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Focus Area:Prevention
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Biomedical Interventions: Oral Pre-exposure Prophylaxis (PrEP) for HIV Prevention
I. Definition of the Prevention Area
Pre-exposure prophylaxis (PrEP) aims to prevent acquisition of HIV through use of antiretroviral (ARV) agents before potential exposure to HIV. Several trials of daily oral PrEP have been completed, and other trials of daily and intermittent use of oral PrEP and injectable agents are underway. The primary strategy being tested involves daily use of one (tenofovir [TDF]) or two (TDF/emtricitabine [FTC]) oral ARV drugs.
II. Epidemiological Justification for the Prevention Area
A safe, effective, and acceptable oral prevention regimen could provide another tool for HIV prevention programs. Three placebo-controlled clinical trials have shown significant reduction in HIV acquisition among HIV-negative persons who received an ARV pill to take daily, as shown in the following:
Study Drug
Men who have sex with men, transgendered women;
Risk reduced by 44%; higher protection (73%) among most consistent users
Partners PrEP
TDF and TDF/FTC
Serodiscordant heterosexual couples;
Risk reduced by: 67% (TDF)
Men and women; Botswana
Risk reduced by 62%
One placebo-controlled trial (FemPrEP) and the oral TDF arm of the VOICE trial were stopped early when data reviews determined that they would be unlikely to answer the study question. (VOICE continues to evaluate daily oral TDF/FTC.). Both trials studied the impact of PrEP in African women.
Data from all these trials suggest that effectiveness is strongly correlated with adherence and that thus far the incidence of acquiring drug-resistant HIV is low. The FemPrEP trial data strongly suggest that the lack of effectiveness was due mainly to women in the trial not taking the tablets consistently. Researchers are continuing to work to understand the interaction between the behavioral and biomedical aspects of these results, and the implications for PrEP.
III. Core Programmatic Components
Roll-out of ARV PrEP has not started, but programs would involve the following components:
- Educating health workers and at-risk populations
- Producing, distributing, and providing ARVs for PrEP
- Recruiting risk candidates who may not wish to disclose risk factors with sensitivity
- Providing individual education and counseling and adherence support
- Testing for HIV before PrEP is provided
- Selecting the regimen
- Following up regularly to assess safety, toxicity, HIV status, and potential resistance
- Identifying and costing service delivery approaches.
Successful implementation would depend on active involvement of national ministries of health, normative agencies, donors, provider organizations, and community groups.
IV. Current Status of Implementation Experience
PrEP is not yet being rolled out in programs largely due to the cost of the approach in large populations and concerns about adverse effects in HIV-negative individuals, yet the optimal approach is being explored through implementation science studies. For example, iPrEX-OLE is exploring implementation questions with iPrEX trial participants; implementation studies are also beginning in the United States. Attention is increasingly focused on implementation questions. Will PrEP need to be taken every day? Will intermittent dosing be effective, less costly, and easier to use? What is the best way to provide PrEP (e.g., service setting, packaging, pricing)? Which groups or individuals should be prioritized? Will side effects prove tolerable to healthy people? Will PrEP promote emergence of resistant HIV? Will people taking PrEP engage in riskier behaviors, offsetting PrEP's benefits? Will PrEP be safe and effective for women who are pregnant or wish to conceive? How can the global health community best balance using ARVs for PrEP with providing ARVs for treatment?
The Centers for Disease Control and Prevention has issued interim guidance for PrEP among men who have sex with men in the United States while formal guidance is developed. Gilead Sciences, the pharmaceutical company that sponsors TDF and TDF/FTC, submitted data to the U.S. Food and Drug Administration requesting a labeling change that approves TDF/FTC as PrEP to reduce the risk of HIV acquisition among adults. The request is being considered under priority review. Efforts to build on completed and ongoing trials are important to understand how best to utilize this potentially important new tool for HIV prevention.
HIV Preexposure Prophylaxis: New Data and Potential Use
Celum, C. L. Topics in Antiviral Medicine (December 2011/January 2012), Vol. 19 No. 5.
This commentary reviews the history of pre-exposure prophylaxis (PrEP) for HIV prevention and evidence to date. Most of the drugs studied are based on tenofovir (tablets or gel) or tenofovir combined with emtricitabine. Four studies have demonstrated PrEP's safety and effectiveness (CAPRISA 004, Partners PrEP, iPrEX, and TDF2) in reducing HIV transmission while two (FemPREP and VOICE) have not shown effectiveness. Drug adherence is critical and complex to ensure and to measure. Further analyses and ongoing trials will provide insights on key issues and PrEP's potential in new populations. It outlines key issues related to implementation, reviewing evidence and outstanding questions: defining "high risk," identifying individuals who may benefit, identifying those health facilities best positioned to provide PrEP, counseling, risk assessment and safety monitoring, and cost. PrEP roll-out will be complex, and implementation studies are key to informing sound program design. The author concludes that implementing new prevention strategies is a welcome challenge.
ARV PrEP for HIV-1 Prevention among Heterosexual Men and Women
Baeten, J., Donell, D., Ndase, P., et al; the Partners PrEP Study Team. 19th Conference on Retroviruses and Opportunistic Infections (2012), Paper #29.
The Partners PrEP trial enrolled 4,758 HIV serodiscordant, heterosexual couples in Kenya and Uganda in a randomized three-arm trial evaluating daily tenofovir (TDF) or emtricitabine (FTC)/TDF against placebo to prevent HIV infection. Participating couples received a standard HIV treatment and prevention package, including risk-reduction counseling and condoms. Both regimens reduced the risk of HIV-1 infection among the HIV-negative male or female partner; TDF was 67 percent efficacious and FTC/TDF was 75 percent efficacious. (Of 82 HIV infections, 17 occurred in the TDF arm, 13 in the FTC/TDF arm, and 52 in the placebo arm). Both regimens were safe, HIV-1 resistance was rare, and adherence was high. In July 2011, the trial's independent Data and Safety Monitoring Board recommended the study results be reported and the placebo arm discontinued early due to strong evidence of effectiveness. The trial showed that among heterosexual men and women with a known HIV-1–infected partner, daily oral TDF and FTC/TDF safely and substantially reduced the risk of HIV-1 infection. Data in this abstract will later be reported in a peer-reviewed journal article.
The FEM-PrEP Trial of Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) among African Women
Van Damme, L., Corneli, A., Ahmed, K., et al; FEM-PrEP Study Group. 19th Conference on Retroviruses and Opportunistic Infections (2012), Paper #32LB.
This abstract reports on FEM-PREP, an oral pre-exposure prophylaxis (PrEP) trial in women in Africa that stopped early for futility after a planned interim analysis determined that the trial was unlikely to be able to demonstrate effectiveness. This randomized, double-blind, placebo-controlled trial enrolled 2,120 women in South Africa, Kenya, and Tanzania to study whether once-daily oral emtricitabine (FTC)/tenofovir (TDF) reduces the risk of HIV infection. Thirty-three infections occurred in the FTC/TDF group and thirty-five in the placebo group (estimated hazard ratio 0.94). The study found no resistance to TDF, and the four cases of resistance to FTC waned over time. Drug-level analysis showed lower adherence than self-report or pill count data. Despite substantial efforts to support participants to take the tablets, it appears that low adherence to the study drug may have undermined the trial's ability to determine whether FTC/TDF is effective in reducing the risk of HIV. This underscores the critical role of adherence in PrEP and the importance of future PrEP trials and programs focusing on adherence. Data in this abstract will later be reported in a peer-reviewed journal article.
Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana: Results from the TDF2 Study
Thigpen, M. C., Kebaabetswe, P. M., Smith, D. K., et al. International AIDS Society, Rome (2011), Paper WELBC01 - Oral Abstract.
The TDF2 study demonstrated that daily oral antiretroviral therapy can reduce HIV acquisition among uninfected men and women exposed through heterosexual sex. In this trial, 1,219 HIV-seronegative male and female participants aged 18 to 39 were randomized to receive either oral tenofovir (TDF)/emtricitabine (FTC) or matching placebo once daily. Monthly study visits included HIV testing and risk reduction counseling, sexually transmitted infection management, and adverse event monitoring. The overall protective efficacy was 62.6 percent, with greater efficacy (77.9 percent) when the analysis included only those who were actually on study medication when infected. There were no reported differences in serious adverse events, and adherence (measured by pill count) was similar across the active and placebo groups. This study shows that daily TDF/FTC was effective and safe for preventing HIV infection among heterosexual men and women. Data from other pre-exposure prophylaxis (PrEP) studies underway, and further analysis of TDF2 results including drug level testing, will provide additional information to help determine how to position PrEP for use in heterosexual populations.
Pre-exposure Chemoprophylaxis for Prevention of HIV Among Trans-women and MSM: iPrEx Study
Grant, R., Lama, J., Glidden, D.; iPrEx Study Team. 18th Conference on Retroviruses and Opportunistic Infections, Boston (2011), Abstract 92.
This abstract discusses additional data from the iPrEX trial on effectiveness, durability of the effect, and adverse events. Data in the presentation slides indicate that the protective effect of emtricitabine (FTC)/tenofovir (TDF) to reduce HIV infection continued for the additional 12 weeks of the trial. These data also confirmed the dose response of effectiveness: FTC/TDF's efficacy in preventing HIV acquisition increased to 68 percent among those who used the drugs most consistently (> 90 percent of doses). There was no evidence of resistance among participants who became infected after starting pre-exposure prophylaxis or of increased risk behaviors. No difference was observed in serious adverse events; adverse events in the FTC/TDF arm (headache, nausea, weight loss) were resolved. Creatinine was somewhat elevated, which may warrant further follow-up. Issues will continue to be studied in iPrEX-OLE, the trial open label extension that should offer more insights into drug use when participants know the drug is effective.
Predicting the Impact of ART and PrEP with Overlapping Regimens on HIV Transmission and Drug Resistance in South Africa
Abbas, U., Glaubius, R., Mubayi, A., et al. 18th Conference on Retroviruses and Opportunistic Infections, Boston (2011), Abstract 98LB.
With increased access to antiretroviral therapy (ART) in South Africa, and tenofovir-based drugs included in first-line treatment, introducing these same agents as pre-exposure prophylaxis (PrEP) may increase resistance and limit their effectiveness for treatment. This model worked to predict the effect of increased ART and PrEP implementation on spread of HIV and drug resistance in South Africa. The models included sexual behavior, HIV transmission, HIV disease progression, and the emergence of drug resistance in the context of the heterosexual HIV epidemic in South Africa. It looked at cumulative new infections prevented and the prevalence of transmitted and acquired resistance from ART and from PrEP. The model suggests that while ART and PrEP together will have a bigger impact on HIV prevention than either ART or PrEP alone, using the same drugs for both treatment and prevention will increase the prevalence of drug resistance. PrEP roll-out would be expected to contribute far less to drug resistance than ART. However, consistent with several other models, this work suggests that PrEP use by people already infected with HIV could increase resistance from PrEP.
MTN-001: A Phase 2 Cross-over Study of Daily Oral and Vaginal TFV in Healthy, Sexually Active Women Results in Significantly Different Product Acceptability and Vaginal Tissue Drug Concentrations
Hendrix, C., Minnis, A., Guddera, V., et al; MTN-001 Study Team. 18th Conference on Retroviruses and Opportunistic Infections, Boston (2011), Abstract 35LB.
This is the first study to compare tenofovir oral tablets and vaginal gel in the same women. It studied acceptability of the two formulations and how the different drug regimens were absorbed by and distributed in the body. Women in the United States and Africa used the vaginal gel, the oral tablet, or both daily for six weeks and then switched. All three regimens were safe and well tolerated, and self-reported adherence was very high (94 percent). Most participants reported they would be "likely" to use the products: oral (93 percent), vaginal (83 percent), and both (82 percent). All (100 percent) of women in the African sites said they would use either tablets or gel. U.S. women preferred tablets (72 percent), while women at the African sites preferred each equally and liked that the gel increased sexual pleasure. Gel use resulted in much higher drug concentrations in the vaginal tissue, whereas the tablet was associated with a higher concentration in blood. This study confirms that different women prefer different regimens, that overall acceptability for both is high, and that the regimens may work differently because of drug availability.
Factors Influencing the Emergence and Spread of HIV Drug Resistance Arising from Rollout of Antiretroviral Pre-exposure Prophylaxis (PrEP)
Abbas, U. L., Hood, G., Wetzel, A. W., et al. PLoS One (2011), Vol. 6 No. 4, p. e18165.
This study used mathematical modeling to examine factors that may influence the prevalence of HIV drug resistance after pre-exposure prophylaxis (PrEP) implementation. PrEP regimens being tested use some of the same antiretroviral drugs that are used to treat AIDS. The possibility that PrEP could contribute to drug resistance, limiting the effectiveness of these drugs for treatment, is a concern. In the model, PrEP was introduced when HIV prevalence among sexually active 15- to 49-year-olds reached 20 percent, mirroring a "sub-Saharan" epidemic. The model included many different factors (age, gender, sexual activity, HIV status, stage of disease, coverage and discontinuation of PrEP, and HIV drug susceptibility) and simulated three scenarios to look at the impact of PrEP on HIV prevention and drug resistance. The model indicates that the rate and length of PrEP use by people already infected with HIV is the most important driver in HIV drug resistance in this population. These outcomes underscore the important role that HIV testing and monitoring will need to play in PrEP programs in order to mitigate the spread of resistance.
Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men
Grant, R. M., Lerma, J. R., Anderson, P. L., et al. New England Journal of Medicine (2010), Vol. 363 No. 27, pp. 2587-2599.
This article reports results of the iPrEX study, which demonstrated that oral pre-exposure prophylaxis (PrEP) reduced the risk of HIV acquisition by 44 percent among men and transgendered women who have sex with men. The 2,499 HIV-negative participants enrolled in iPrEX were randomized to receive emtricitabine (FTC)/tenofovir (TDF) or placebo once daily; all participants received a comprehensive HIV risk reduction package. The trial took place in Brazil, Ecuador, Peru, South Africa, Thailand, and the United States. Of the 100 incident HIV infections, 36 occurred in the FTC/TDF group and 64 in the placebo group. The authors report that while self-reported adherence to the study regimen was high, adherence based on drug blood levels was substantially lower. The study concludes that PrEP is effective for slowing the spread of HIV in this population. However, it cautions that the optimal PrEP regimen has not been established and that data from iPrEX cannot be applied to other populations, which are being studied in other PrEP trials.
HIV Preexposure Prophylaxis in the United States: Impact on Lifetime Infection Risk, Clinical Outcomes, and Cost-Effectiveness
Paltiel, A. D., Freedberg, K. A., Scott, C. A., et al. Clinical Infectious Diseases (2009), Vol. 48, pp. 806-815.
This study forecasts clinical, epidemiologic, and economic impact of pre-exposure prophylaxis (PrEP) using emtricitabine (FTC)/tenofovir (TDF) delivered to men who have sex with men (MSM) in the United States who are at high risk of HIV infection. It predicts reduced lifetime HIV risk in U.S. MSM but also predicts a high discounted mean lifetime treatment cost. The study used a common computer simulation of HIV acquisition, detection, and care, and also sought to account for a number of uncertainties, including the level of effectiveness, risks of resistance and toxicity, behavioral disinhibition, and drug costs. It calculated outcomes including lifetime risk of infection, life expectancy, quality-adjusted life expectancy, and cost. It concludes that PrEP could have a substantial impact on the incidence of HIV transmission among the study population. Using this model's assumptions about efficacy (50 percent) and cost (U.S.$753/month), FTC/TDF PrEP is not currently seen as cost-effective based on quality-adjusted life-year gained. However, lower prices and/or higher efficacy could make it cost-effective, especially in younger or high-risk populations. Despite concerns about cost-effectiveness, and in light of the limits of other HIV prevention interventions and research, the authors conclude that additional study of PrEP is warranted.
Circulating HIV Type 1 Drug Resistance will Have Limited Impact on the Effectiveness of Preexposure Prophylaxis among Young Women in Zimbabwe
van de Vijver, D. A., Derdelinckx, I., & Boucher, C. A. Journal of Infectious Diseases (2009), Vol. 199, pp. 1310-1317.
Potential for drug resistance is a concern with pre-exposure prophylaxis (PrEP) roll-out, and this study uses risk equations to predict whether PrEP, in the presence of circulating drug resistance, will reduce the risk of infection with HIV. The model calculated the monthly risk of infection with HIV before and after the introduction of PrEP. Analyses were performed for different ranges of PrEP's effectiveness and assumptions about the degree to which circulating drug resistance would reduce PrEP's effectiveness and the transmissibility of HIV. The model used actual data on women aged 17 to 29 in Zimbabwe. Unlike previous models, it incorporated condom use as well as the potential impact of drug resistance. Based on their analysis, the authors conclude that circulating drug resistance will not have a substantial impact on the effectiveness of PrEP or its public health impact. Instead, these will depend mainly on various other factors: the drug's efficacy and risk behaviors including overall condom use, frequency of sex, the degree to which PrEP is substituted for condoms, and the degree to which people not currently using condoms do use PrEP. The authors underscore the importance of behavioral interventions as integral to PrEP introduction.
The Impact of Pre-exposure Prophylaxis (PrEP) on HIV Epidemics in Africa and India: A Simulation Study
Vissers, D. C. J., Voeten, H. A. C. M., Nagelkerke, N. J. D., et al. PLoS One (2008), Vol. 3, pp. e2077.
This mathematical modeling (simulation) study estimated the potential long-term impact of pre-exposure prophylaxis (PrEP) in different epidemics in India, Botswana, and Kenya among sex workers and their clients. Although this model used a similar scenario as did Abbas et al. in their model, Vissers et al. predicted a smaller impact of PrEP in sub-Saharan Africa (0.14 averted HIV infections per person per year of PrEP compared to 0.33 averted HIV infections per person per year). The predicted impact of PrEP in southern India was much lower than that in sub-Saharan Africa. In southern India, levels of condom use during commercial sex acts are relatively high, so lower rates of condom use could substantially decrease or even negate the impact of PrEP in that setting. This model suggests that the public health impact of PrEP can be substantial, but may be diminished, or even reversed, by changes in risk behavior. PrEP implementation needs to not be seen as a substitute for condoms.
Changes in Sexual Risk Behavior among Participants in a PrEP HIV Prevention Trial
Guest, G., Shattuck, D., Johnson, L., et al. Sexually Transmitted Diseases (2008), Vol. 35, pp. 1002-1008.
Potential for increasing risk behaviors is a common concern related to pre-exposure prophylaxis or other new HIV prevention approaches. This study was conducted among women in Ghana who participated in safety and effectiveness trial of daily oral tenofovir to prevent HIV. All participants received condoms and risk reduction counseling. (The trial was stopped early so did not determine whether oral tenofovir was effective for HIV prevention.) Analysis of self-reported sexual behavior and qualitative data was used to map changes in sexual risk behavior. In contrast to concerns about risk compensation, the study found that risk behavior, on average, decreased across the 12-month trial. This is consistent with findings from other HIV prevention trials. In this study, both the number of sexual partners and rate of unprotected sex acts declined. Subanalysis indicated that "risky" women with more partners were also more likely to use condoms and less likely to have other high-risk behaviors like anal sex. Participants attributed their behavior change to the counseling they received. While the trial's HIV prevention counseling was effective overall, subgroups may need different approaches and messages. These findings may also be relevant to sample size calculations for future HIV prevention trials.
Tenofovir Disoproxil Fumarate for Prevention of HIV Infection in Women: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Trial
Peterson, L., Taylor, D., Roddy, R., et al. PLoS Clinical Trials (2007), Vol. 2, p. 327.
This was the first completed clinical trial to date on the use of tenofovir pre-exposure prophylaxis (PrEP) in humans. The trial was designed to assess safety and preliminary efficacy of PrEP with daily tenofovir in HIV-negative women at high risk for HIV infection. However, efficacy could not be assessed due to premature closures of the study sites in Cameroon and Nigeria. A total of 936 HIV-negative women were randomized to tenofovir or placebo. Tenofovir was not associated with increased adverse events compared to the placebo. Two women on tenofovir and eight women on placebo were diagnosed with new HIV infections during the trial, but the difference was not statistically significant. All women received standard of care prevention counseling. The average number of sexual partners in the past month decreased from 21 at baseline to 14 during follow-up. Reported condom use increased from 52 percent at baseline to 95 percent at the 12-month follow-up. This study demonstrated that tenofovir is safe for HIV-negative women, but it was not able to assess efficacy.
Potential Impact of Antiretroviral Chemoprophylaxis on HIV-1 Transmission in Resource-limited Settings
Abbas, U. L., Anderson, R. M., & Mellors, J. W. PLoS One (2007), Vol. 2, p. e875.
Clinical trials are evaluating the efficacy of pre-exposure prophylaxis (PrEP), but will not specifically assess its public health impact. A mathematical model was used to simulate the effects of PrEP on an HIV-1 epidemic in sub-Saharan Africa with optimistic, neutral, and pessimistic scenarios. The optimistic scenario assumed 90 percent efficacy of PrEP, 75 percent coverage of the general HIV-uninfected population, and no change in sexual behavior among persons taking the medication. With these assumptions, the model predicted a 74 percent decline in cumulative new HIV infections after 10 years. If PrEP were targeted to the highest risk groups (16 percent of the population), the model estimated a 28.8 percent decline in new infections. This approach could avert 2.7 to 3.2 million new HIV-1 infections in southern sub-Saharan Africa over 10 years. The neutral scenario predicted a 6.8 percent decrease in new HIV infections with a risk-targeted strategy; the pessimistic scenario predicted a 0.8 percent decrease. The projected decreases would be partially offset, however, if people using PrEP increased risky sexual behavior or discontinued the drugs. These results suggested that PrEP could be cost-effective if efficacy and adherence were high, long-term use were sustained, and sexual disinhibition were prevented.
Interim Guidance: Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men
Smith, D. K., Grant, R. M., Weidle, P. J., et al. Morbidity and Mortality Weekly Report (2011), Vol. 60 No. 3, pp. 65-68.
U.S. public health agencies are developing guidelines for pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM), but they will take time to complete and publish. These interim recommendations are intended to guide clinical practice so that MSM and providers avoid possibly unsafe and less-effective PrEP regimens. The article notes that in iPrEX, emtricitabine (FTC)/tenofovir (TDF) PrEP showed a significant added benefit within a comprehensive HIV prevention package, and cites a safety study of TDF for PrEP among MSM in the United States. It concludes that daily FTC/TDF as PrEP can contribute to HIV prevention for MSM if it is targeted to MSM at high risk for HIV, it is delivered as part of a comprehensive prevention package, and it includes regular monitoring of HIV status, side effects, adherence, and risk behaviors. The guidance includes specific recommendations for determining eligibility, beginning the regimen, follow-up, and discontinuation. It notes that PrEP should only be considered for MSM until trials in other populations are completed.
Antiretroviral Agents Used by HIV-Uninfected Persons for Prevention: Pre- and Postexposure Prophylaxis
Grant, R. M. Clinical Infectious Diseases (2010), Vol. 50 Suppl. 3, pp. S96–101.
This article reviews evidence, status, and challenges related to use of antiretroviral therapy in HIV prevention, including preclinical and clinical research, and implementation. Lack of animal models and surrogate markers for HIV prevention mean efficacy must be assessed in large trials that enroll healthy people. Prevention trials work with communities to provide a range of information and services, experience that will be valuable to inform roll-out of new prevention approaches in these communities. Pre-exposure prophylaxis (PrEP) is a "biomedical" prevention product that also depends on access and use, so has crucial behavioral, social, and economic dimensions. Concerns about PrEP include adherence, resistance, and risk compensation. These may or may not prove to be problems. Adherence, uneven in trials, may improve once the drugs are proven safe and effective. Implementation will need to incorporate HIV testing, key to identifying HIV infection and limiting resistance. More sensitive HIV tests appropriate for service settings are a priority. Increased sexual risk taking has generally not been seen in trials; new prevention tools may increase people's interest and ability to use protection without increasing risk taking. Cost-effectiveness of PrEP and programs to deliver it will be related to efficacy, dosing, targeting at-risk populations, and other factors.
Planning for Pre-exposure Prophylaxis to Prevent HIV Transmission: Challenges and Opportunities
Kim, S. C., Becker, S., Dieffenbach, C., et al. Journal of the International AIDS Society (2010), Vol. 13 No. 24.
This paper outlines key action points from a 2009 international meeting "Planning for PrEP" that launched a collaborative program of work on the major policy, regulatory, delivery, program implementation, and user-perspective issues related to pre-exposure prophylaxis (PrEP). Participants identified research and action steps needed to complement clinical trial data to maximize the public health impact of PrEP. They recommended developing a "proof of deliverability" pathway, analogous to the "proof of concept" studies in clinical research, to demonstrate PrEP's feasibility in different cultural, ethical, legal, and political settings. The group identified priority activities: model costs and benefits for different epidemics and populations, factoring in testing and resistance, conduct targeted market research, establish regulatory pathways that will influence funders and policymakers, and develop an implementation framework. The article highlights the importance of ensuring coordination, collaboration, and effective communication; country ownership; and working with normative bodies. Recognizing that clinical trial results are just one step in PrEP becoming a public health intervention, the article underscores that this work must be done concurrent with clinical research.
Packaging PrEP to Prevent HIV: An Integrated Framework to Plan for Pre-Exposure Prophylaxis in Clinical Practice
Underhill, K., Operario, D., Skeer, M. R., et al. Journal of Acquired Immune Deficiency Syndromes (2010), Vol. 55 No. 1, pp. 8-13.
Recognizing the challenges of transitioning from clinical trials to program implementation, this commentary proposes a five-part structure for optimizing pre-exposure prophylaxis (PrEP) implementation in clinical practice: prescription, safety screening, behavioral intervention, integration of PrEP with other health care services, and population-level monitoring. Providing drugs will require eligibility guidelines and clinical algorithms for different populations and settings. Feasibility and costs related to monitoring safety (HIV testing, resistance, side effects, sexually transmitted infections) will be key to individual- and population-level impact. Behavioral interventions and support to optimize dosing, promote adherence, and minimize risk behaviors will be critical through both counseling and community education. Behavioral interventions may be difficult to standardize in guidelines and across user groups. Services will need to be established in diverse clinical settings to reach different users and may need to combine clinical and non-clinical service providers to deliver all program components. PrEP users will be in regular contact with care, likely over a long period of time, and as such will need integrated care and referral systems. Finally, national monitoring and evaluation systems will be critical to generate information for adjusting guidelines and determining whether PrEP has an overall benefit.
Pre-exposure Prophylaxis State of the Science: Empirical Analogies for Research and Implementation
Golub, S. A., Operario, D., & Gorbach, P. M. Current HIV/AIDS Reports (2010), Vol. 7 No. 4, pp. 201-209.
Underscoring that the potential of pre-exposure prophylaxis (PrEP) as a new biomedical intervention for HIV prevention will depend on behavioral and social factors, this article reviews knowledge across a number of behavioral and social science disciplines to draw out lessons for PrEP. It focuses on three individual-level behaviors: adoption of PrEP, adherence to PrEP regimens, and sustained risk reduction practices. A table summarizes the most relevant analogies. Key issues regarding adoption of PrEP include communicating and processing risk and probability to address partial effectiveness, comprehension and application of information on risk in decision making, framing effects as positive or negative, and stigma and its impact on behavior. Lessons from antimalarial prophylaxis, treating latent tuberculosis, oral contraceptive pills, and HIV treatment can inform adherence strategies. Information relevant to sustained risk reduction can be drawn from research on risk perception and how it informs decisions and behaviors in HIV prevention and highly active antiretroviral therapy programs. In presenting empirical analogies directly relevant to PrEP implementation, this article emphasizes that interdisciplinary learning will be critical to the success of PrEP.
Acceptability of PrEP for HIV Prevention Among Women at High Risk for HIV
Guest, G., Shattuck, D., Johnson, L., et al. Journal of Women's Health (2010), Vol. 19 No. 4, pp. 791-798.
This paper reports on acceptability in an early pre-exposure prophylaxis trial assessing the effectiveness of daily oral tenofovir among 400 women in Ghana to prevent HIV infection. (The trial was stopped early.) The study used structured questionnaires and qualitative interviews, and the analysis includes participants' perspectives and social and contextual factors as well as adherence measures. Overall, acceptability was good, and reported adherence to the daily pill was > 82 percent. Problems generally declined as physical side effects decreased, and participants devised strategies for making pill-taking part of their routine. This suggests that future programs will likely need to provide users with enough time to become accustomed to the product and its use. The authors recommend that efforts continue to develop better acceptability measures and to examine the complex interplay among adherence, safety, and effectiveness. While it is unclear how findings from a clinical trial may translate into more routine service settings, this study suggests that a daily oral pill may be a feasible HIV prevention option.
Implementation Science of Pre-exposure Prophylaxis: Preparing for Public Use
Underhill, K., Operario, D., Mimiaga, M. K., et al. Current HIV/AIDS Reports (2010), Vol. 7, pp. 210-219.
This article reviews published and unpublished literature on pre-exposure prophylaxis (PrEP) implementation and organizes the issues and challenges raised around five themes: scientific groundwork, regulatory and policy groundwork, stakeholder and infrastructure groundwork, delivery, and long-term monitoring. It identifies more detailed topics under each of these themes. It argues that PrEP, comprised of biomedical, behavioral, and structural elements, exemplifies the increasing emphasis on multifaceted HIV prevention strategies. As such, PrEP provides an impetus to shape and expand the field of implementation and delivery science for HIV prevention. Lessons from PrEP planning can benefit other combination interventions to prevent HIV. The authors propose that the framework of five themes can serve as a starting point for thinking systematically about PrEP implementation and the broader field of implementation science.
Evaluating the Cost-Effectiveness of Pre-Exposure Prophylaxis (PrEP) and Its Impact on HIV-1 Transmission in South Africa
Pretorius, C., Stover, J., Bollinger, L., et al. PLoS One (2010), Vol. 5 No. 11, p. e13646.
The article presents results of a modeling exercise that aimed to estimate the cost-effectiveness as well as the potential impact of pre-exposure prophylaxis (PrEP) on HIV transmission in the context of expanding antiretroviral therapy (ART) programs. Using a model developed to study the ART program in South Africa, it examines the coverage and potential impact on HIV incidence of ART and PrEP programs compared to a scenario where ART coverage expands at its current rate. Its assumptions about cost for PrEP and ART include services like counseling and testing as well as the drugs. The model varies levels of condom substitution, targeting high-risk groups, and coverage, and finds that the most cost-effective approach would involve targeting women aged 25 to 35 in an optimistic efficacy scenario (90 percent). The model finds that assuming growing availability of ART, PrEP has a "window" within which it would be cost-effective as treatment rolls out, relative to universal test and treat, which is both a treatment and prevention approach. It notes the role of other prevention interventions; while PrEP and universal test and treat are effective relative to other interventions, they are also relatively expensive. It recommends additional work in other settings with generalized epidemics and ART programs.
Preexposure Antiretroviral Prophylaxis Attitudes in High-risk Boston Area MSM: Limited Knowledge and Experience but Potential for Increased Utilization after Education
Mimiaga, M. J., Case, P., Johnson, C. V., et al. Journal of AIDS (2009), Vol. 50, pp. 77-83.
This paper reports findings from a study of 227 HIV-uninfected men who have sex with men (MSM) in the Boston, MA, area. Recognizing that intentions to use pre-exposure prophylaxis (PrEP), acceptability, and adherence will be critical to PrEP's use-effectiveness, the study explored behavioral and demographic characteristics likely to be associated with intention to use PrEP among MSM. After being given information about PrEP, participants were interviewed about their knowledge of and intention to use PrEP as well as a range of demographic and behavioral information. Few (19 percent) in this diverse high-risk MSM population were aware of the potential of antiretroviral therapy for HIV prevention. After hearing about PrEP, most (74 percent) reported an interest in using it, especially if it had no side effects and was available free of charge. Interest in future PrEP use was not associated with higher risk behaviors, but it was associated with relatively lower education and modest income. This study identifies the potential for rapid uptake of PrEP among this population, as well as the importance of careful community and individual educational messages.
Anticipating the Results of PrEP Trials: A Powerful New AIDS Prevention Tool May be on the Horizon. Are We Prepared?
AIDS Vaccine Advocacy Coalition. (2008).
This publication, part of the AIDS Vaccine Advocacy Coalition's Anticipating and Understanding Results series, outlines scientific and policy issues related to pre-exposure prophylaxis (PrEP). While the summary of research results is now dated, it highlights several topics that are not examined in most other resources on PrEP implementation: procurement, resource mobilization, financing, national and international policies, and normative guidance. Given complex and diverse funding structures for AIDS prevention globally, it is important to identify and mobilize potential sources of funding through the Global Fund to Fight AIDS, Tuberculosis and Malaria, the U.S. President's Emergency Plan for AIDS Relief, national budgets, national health plans, and insurance coverage. Building awareness and support for PrEP among national health leaders will lay the groundwork for incorporating PrEP into national AIDS plans, with delivery strategies tailored to specific epidemic profiles. Working with other global health agencies, the World Health Organization should prepare to issue normative guidance for PrEP to ensure it is available as soon as possible after effectiveness is demonstrated. It underscores the importance of adequate and sustained funding for PrEP research and implementation.
Limited Knowledge and Use of HIV Post- and Pre-exposure Prophylaxis among Gay and Bisexual Men
Liu, A. Y., Kittredge, P. V., Vittinghoff, E., et al. Journal of AIDS (2008), Vol. 47, pp. 241-247.
This study examined awareness and use of post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP) among 1,819 HIV-uninfected gay/bisexual men in California. PEP is currently indicated after a high-risk exposure to HIV. At the time of the study, PrEP effectiveness had not been established, but media reports suggested that gay men had started using PrEP and that some physicians were prescribing it. Overall, knowledge of both PEP and PrEP was low, with only 16 percent of the study population aware of PrEP and less than half (47 percent) aware of PEP. Approximately two-thirds (67 percent) of the study participants indicated that they would take PrEP if it were safe and effective. Older, wealthier men with higher risk profiles were more likely to have heard of PEP. Participants who reported risky behaviors were more likely to know about PrEP and to indicate they would be willing to use it. Friends and media were the main sources of information on PrEP, suggesting that accurate reporting and community education campaigns are and will remain critical.
Pre-exposure Prophylaxis for HIV Infection: What if it Works?
Paxton, L. A., Hope, T., & Jaffe, H. W. The Lancet (2007), Vol. 370, pp. 89-93.
This article, written as pre-exposure prophylaxis (PrEP) trials were beginning, presages a number of issues about PrEP research and implementation. Some issues anticipated here—including immediate widespread demand and side effects specific to HIV-negative people—have not proven problematic so far. Resource allocation, risk compensation, and public health policy are addressed within an ethical framework. The authors consider and reject the notion that providing PrEP could tacitly condone risky behavior, arguing that, as public health policy, new prevention should be offered to people regardless of their behavior. Delivering PrEP will require guidelines for use, community education, and infrastructure. Unlike vaccines or microbicides, drugs for oral PrEP are available and can be manufactured at scale. Appropriate HIV counseling and testing may be challenging with fewer resources available than in trials. PrEP will need to be provided in the context of other prevention approaches; prevention is already underfunded, so new resources will be needed. The authors identify marshaling resources from donors, planning for guidelines, and coordinating governments and regulatory agencies as priorities while clinical testing is ongoing. They underscore that despite its complexity, PrEP is a promising potential intervention and should be supported.
Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men
Anderson, P.L., Glidden, D.V., Liu, A., et al. Science Translational Medicine (2012), Vol. 4 No. 151: 151ra125.
In the i-PrEX trial, detectable levels pre-exposure prophylaxis (PrEP) drugs were found in the plasma or peripheral blood mononuclear cells (PBMCs) of 22 of 43 seronegative men who have sex with men (MSM), compared with only 3 of the 34 HIV-infected MSM participating in the intervention arm of the study. The predicted efficacy of the iPrEx trial increased from 44% to more than 90% when detectable drug in the plasma or PBMCs were taken into consideration. The study documented in this article, which was a substudy of iPrEx, seeks to understand the relationship between adherence and drug concentrations in the body. Data from iPrEx and from another study, STRAND, were used to measure the active form of tenofovir (intracellular TFV-DP) in PBMCs, in order to better understand the relationship between TFV-DP concentrations and PrEP efficacy. Data from the iPrEx trial were used to estimate drug concentrations associated with decreased HIV acquisition. Data from the STRAND trial were utilized to establish a link between expected TFV-DP concentrations when two, four, or seven doses of tenofovir disoproxil fumarate (TDF) were directly observed every week. Among STRAND trial participants assigned to receive oral PrEP, the relationship between drug concentration and HIV infection risk was found to be significant. The risk of HIV acquisition was similar in participants in the STRAND trial control arm compared with those in the intervention arm with undetectable concentrations. PrEP efficacy improved when participants were directly observed taking increased doses per week—76 percent when two doses were taken, 96 percent for four doses, and 99 percent for seven. In conclusion, PrEP can be an effective HIV prevention strategy for men who have sex with men with good adherence to a regimen of multiple doses each week.
Antiretroviral Pre-Exposure Prophylaxis (PrEP) for Preventing HIV In High-Risk Individuals
Okwundu, C.I., Uthman, O.A., Okoromah, C.A. Cochrane Database of Systematic Reviews (2012), Vol. 7: CD007189.
Okwundu and colleagues conducted a systematic analysis of six randomized controlled trials of oral pre-exposure prophylaxis (PrEP) to prevent HIV transmission for high-risk individuals—such as people in serodiscordant sexual relationships and men who have sex with men. The review, which includes data from more than 9,849 participants, evaluated daily oral tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) versus placebo, TDF versus placebo, and daily TDF-FTC versus intermittent TDF-FTC. The authors found a 49 percent reduction in risk of acquiring HIV in the four trials comparing TDF-FTC to the placebo. In two of the trials that compared TDF to the placebo, the authors found a 62 percent reduction in risk of acquiring HIV infection. Although participants reported a high rate of adherence in both trials, some participants' drug levels suggested that the level of adherence may be lower than reported.
Preexposure Prophylaxis for HIV Infection Among African Women
Van Damme, L., Corneli, A., Ahmed, K., et al. New England Journal of Medicine (2012), Vol. 367 No. 5, pp. 411-422.
The article reports on the primary findings of the Preexposure Prophylaxis Trial for HIV Prevention among African Women (FEM-PrEP) in Kenya, South Africa, and Tanzania, which was stopped early because the protocol being evaluated did not meaningfully reduce the HIV infection rate. The study was randomized, double blinded, and placebo controlled to test the efficacy of the once-daily oral dose of tenofovir-emtricitabine (TDF-FTC) among women at high risk for HIV infection in an effort to reduce their HIV acquisition. HIV-negative women were recruited between June 2009 and April 2011, and 2,120 women were randomized to the placebo and intervention arms. Of the 68 HIV seroconversions, 33 occurred in the PrEP intervention arm and 35 in the control arm. The estimated hazard ratio in acquiring HIV in the TDF-FTC group, 0.94, was not significant between study groups. Although 95 percent of the women reported "usually" or "always" taking their assigned drug, testing showed drug levels to be quite low among seroconverting TDF-FTC group women, who showed only 26 percent of the target drug levels at the beginning of the infection window and 21 percent at the end of the window. Drug levels in uninfected women in the control group were slightly higher, with 35 percent at the beginning of the infection window and 37 percent at the end of the window. Most women viewed themselves at no or low risk for HIV infection. Because the trial demonstrated no reduction of HIV infection as a result of PrEP, it was therefore stopped. The authors surmise that perception of low risk levels could have triggered poor adherence to the assigned drug regimen, which in turn could have affected its effectiveness.
Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in Botswana
Thigpen, M.C., Kebaabetswe, P.M., Paxton, L.A., et al. New England Journal of Medicine (2012), Vol. 367 No. 5, pp. 423-434.
This randomized, double-blinded, and placebo-controlled study examined the effects of PrEP in an HIV-negative heterosexual population in Botswana as a means to measure its effectiveness in reducing HIV acquisition. The trial closed early because of low retention. All participants exited the study by May 2010, after five years, with the exception of those who acquired HIV, who were pregnant, or who had ongoing serious adverse events; these participants were followed for an additional year. For the original trial, 1,219 participants underwent randomization, and 89.3 percent completed exit procedures. Between the intervention and control arms, there was no significant difference with regards to early withdrawal and loss to follow-up, and adherence rates were similar, based on pill counts and self-reported data. Adverse effects were more numerous, and more statistically significant, in the TDF-FTC group than in the placebo group, with 18.5 percent experiencing nausea, 11.3 percent vomiting, and 15.1 percent dizziness. Bone density declined significantly in the TDF-FTC group compared with the placebo group. Thirty-six participants became infected with HIV during the trial—10 in the intervention group and 26 in the placebo group, equaling a 62.2 percent efficacy level in the TDF-FTC group. Drug levels in those who seroconverted were significantly lower than for those who did not seroconvert. The findings in this trial are consistent with those of other studies, where drug levels are high in the intervention group and that group shows reduced HIV transmission rates.
High Acceptability of HIV Pre-exposure Prophylaxis but Challenges in Adherence and Use: Qualitative Insights from a Phase I Trial of Intermittent and Daily PrEP in At-Risk Populations in Kenya
Van der Elst, E.M., Mbogua, J., Operario, D., et al. AIDS and Behavior (October 2012), e-publication ahead of print.
The qualitative study reported here, conducted between October 2009 and April 2010, sought to understand the acceptability of pre-exposure prophylaxis (PrEP) and PrEP adherence in two populations in Kenya at high risk for acquiring HIV infection—men who have sex with men and female sex workers. The qualitative sample was selected from a larger randomized, placebo-controlled blind trial where daily and intermittent PrEP was prescribed. The intermittent dose of Truvada was prescribed for Mondays and Fridays, and within two hours after sexual intercourse but no more than one dose per day. The 72 participants enrolled in the trial were assigned either to the intervention arm or the placebo arm; 51 participated in the qualitative portion of the study. Focus group discussions and semi-structured, in-depth interviews were conducted with participants who completed the trial, and in-depth interviews were conducted with individuals who discontinued the study or who during their monthly clinical visits revealed low adherence. It was found that acceptability was high and that counseling and commitment increased adherence. Participants suggested that the pill's shape and color could be improved to increase their comfort in taking it and to cause less discoloration in their mouths and thus be less noticeable to others. Side effects subsided over time. Participants preferred the intermittent dosing, but those on intermittent dosing expressed greater difficulties with adherence, especially after sexual intercourse. Barriers to adherence included alcohol use, work schedules, and stigma and discrimination. Risk reduction caused by participation in the study was noted. In conclusion, the authors recommended that behavioral activities such as counseling and social support could enhance PrEP adherence in these high-risk populations.
UNAIDS/WHO Pre-Exposure Prophylaxis Modelling Meeting: Meeting Report
Joint United Nations Programme on HIV/AIDS & World Health Organization. (2011).
This report summarizes discussions among many of the leading mathematical modelers and public health professionals working on pre-exposure prophylaxis (PrEP). Convened by the World Health Organization and the Joint United Nations Programme on HIV/AIDS, participants reviewed PrEP modeling processes, outcomes, and priority next steps. Models discussed addressed the potential impact and cost for delivering oral PrEP and microbicides in different epidemiological contexts and populations. Some also examine potential concerns such as drug resistance and behavioral disinhibition. The report sheds light on some of the thinking and decision making behind assumptions reflected in the models, many of which are in the literature, including what data are used and what additional data would be useful to inform modeling. It includes reflections and recommendations about how these different groups can best coordinate and link their work with demonstration projects and service providers. It also describes the contribution modeling can make to decision making.
PrEP Resources
AIDS Vaccine Advocacy Coalition: Global Advocacy for HIV Prevention. (n.d.).
The AIDS Vaccine Advocacy Coalition (AVAC), a nonprofit organization, works to accelerate the ethical development and global delivery of new and emerging HIV prevention options, including male circumcision, pre-exposure prophylaxis (PrEP), microbicides and AIDS vaccines. Its website includes accessible and substantive summaries, policy analysis, research findings, links, and a range of other resources on all of these HIV prevention options. Information and links for AVAC and external resources are updated regularly. Information on PrEP is presented under three categories: Playbook 2012, summarizing AVAC's analysis, perspectives, and recommendations; What's New, covering recent developments; and Background, with a range of information on PrEP research and implementation. The page contains information and links to a range of resources on PrEP: introductory information, ongoing trials and recent results, and in-depth PrEP resources. It is a helpful source of timely information on PrEP as well as other HIV prevention approaches.
Pre-Exposure Prophylaxis for HIV Prevention: Promoting Safe and Effective Use in the United States
Centers for Disease Control and Prevention. (2011).
This fact sheet from the U.S. Centers for Disease Control and Prevention (CDC) summarizes a number of key issues related to pre-exposure prophylaxis (PrEP) use in the United States. It emphasizes implications for men who have sex with men, noting that effectiveness had only been demonstrated among that population, and includes cautions about what is and is not known, partial effectiveness and the need to use PrEP in conjunction with other risk reduction measures, and the importance of adherence and close collaboration with a health provider. It outlines practical interim guidance for physicians as formal guidelines are being developed, and maps out CDC's approach to developing those formal U.S. public health service guidelines in collaboration with other key agencies.
Ongoing and Planned Pre-Exposure Prophylaxis (PrEP) Trials
AIDS Vaccine Advocacy Coalition, (2012).
This summary table lists all ongoing and planned PrEP trials: open label; safety and effectiveness; and safety, adherence, acceptability, and feasibility. It contains brief descriptions of each trial's phase, start date, sponsor/funder, location, population, intervention arm(s), and the status and/or when results are expected. Information in the table is updated periodically.
A Cascade of Hope and Questions: Anticipating the Results of ARV-based HIV Prevention Trials: Volume 1
AIDS Vaccine Advocacy Coalition. (2010).
Published just prior to the International AIDS conference in Vienna and in anticipation of the CAPRISA 004 tenofovir gel trial results, this publication contextualizes pre-exposure prophylaxis (PrEP) research within the broader arena of antiretroviral-based prevention trials (which included tenofovir in a vaginal gel as well as oral PrEP). It describes how HIV prevention trials are conducted and maps out several scenarios and the implications for further research, ongoing trials, implementation programs, and advocacy.
Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults
U.S. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report (2012), Vol. 61 No. 31, pp. 586-589.
Epidemiologists at the U.S. Centers for Disease Control and Prevention have issued interim guidance on pre-exposure prophylaxis (PrEP) for heterosexual adults in the wake of the U.S. Food and Drug Administration's approval of Truvada, a combination antiretroviral drug, for use as PrEP. This new guidance is based on data from four different clinical trials that randomized participants to receive combination oral PrEP of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)—the two active components of Truvada—or a placebo. In two of the studies, daily oral TDF/FTC was found to be safe for reducing the risk of sexual HIV transmission when used consistently. The four primary guidelines include: 1) contraindication for PrEP for those with positive or unknown HIV status; 2) daily PrEP for men and women at high risk of acquiring HIV from penile-vaginal intercourse; 3) use by serodiscordant couples attempting to conceive; and 4) pregnancy testing for women before starting PrEP and periodically during PrEP, so that, if they become pregnant, health care providers can advise them of the possible risks and benefits of continuing PrEP during the pregnancy. The guidance also advises health care providers to tell patients that PrEP efficacy depends on adherence to daily doses and that the long-term safety for HIV-negative adults or fetuses has not yet been determined.
Guidance on Oral Pre-exposure Prophylaxis (PrEP) for Serodiscordant Couples, Men and Transgender Women Who Have Sex with Men at High Risk of HIV: Recommendations for Use in the Context of Demonstration Projects
World Health Organization (2012).
Clinical trials of regimens for pre-exposure prophylaxis (PrEP) have been successful in two populations—men and transgender women who have sex with men (MSM-TG) and serodiscordant heterosexual couples. However, how these results translate to real world settings is less known. The World Health Organization (WHO) recommends that countries implement demonstration projects that will offer advice on key safety, effectiveness, adherence, and sustainability questions surrounding PrEP interventions. The guidance provides an overview of the research conducted to date and recommendations on PrEP for serodiscordant couples, MSM-TG, and other groups. The guidance lists nine key points to guide demonstration projects, among them ensuring the HIV-negative status of participants, monitoring participants' safety, supporting high adherence levels, and developing transition mechanisms for those who want or need to discontinue treatment. Plans are for the WHO to review and revise this guidance in 2015.
AVAC, Global Advocacy for HIV Prevention
The website offers the latest news on the past, present, or ongoing status of biomedical HIV prevention research studies. Readers can review summary tables from various HIV prevention clinical trials, search information on prevention trials, see what is new on the site this month, and review the user's guide for help in using the site. The site offers information about the following biomedical prevention trials: microbicides, pre-exposure prophylaxis, treatment as prevention, and vaccines.
PrEP Using Daily Oral TDF/FTC or TDF in Women (and Men): What the Science Tells Us in March 2012
AIDS Vaccine Advocacy Coalition. (2012).
This one-page brief, aimed at advocates, summarizes the implications of concluded and ongoing clinical trials and other research on pre-exposure prophylaxis (PrEP), including new information presented at the 2012 Conference on Retroviruses and Opportunistic Infections. It states that PrEP using a daily oral tenofovir (TDF) or TDF/emtricitabine (FTC) tablet reduces the risk of HIV in women and men, and summarizes the information to support this statement. It provides brief descriptions of information to support additional conclusions from PrEP research to date, underscoring that adherence is critical to effectiveness, that risk perception appears to contribute to an individual's willingness and ability to adhere to the daily regimen, and that regular HIV testing is and will remain critical to addressing resistance. Finally, the brief identifies pregnant women and adolescents as among the key groups where more data are needed.
View Report (PDF, 222 KB)
Partners PrEP Study Demonstrates that PrEP Significantly Reduces HIV Risk: Key Messages
University of Washington, International Clinical Research Center. (2011).
This document lists "key messages" prepared by the study team in anticipation of the release of results from the Partners PrEP study. Randomization was stopped early at the recommendation of the trial's independent Data Safety and Monitoring Board due to overwhelming evidence of effectiveness, and results were announced at the International AIDS Conference in July 2011, just a week later. This document provides an overview of the trial, its conduct, the trial findings, and their implications for pre-exposure prophylaxis in these and other populations.
View Report (PDF, 64 KB)
PrEP Implementation Policy Forum: Developing Country-level Preparation and Capacity for PrEP Implementation
International AIDS Society. (2007).
This report contains proceedings of a policy forum focused on country-level preparedness for pre-exposure prophylaxis (PrEP). It outlines approaches for translating research into policy and deriving lessons from implementation planning for male circumcision for HIV prevention. Ministry of Health representatives from several key countries emphasized that country-level preparedness will be predicated on the evidence, defining target populations, cost and financing, and addressing stigma and integration into existing health systems. The report also addresses designing global and national PrEP guidelines and affordability and availability of PrEP drugs. It concludes with 10 "Key Take Home Messages" to consider in preparing for PrEP implementation.
View Report (PDF, 162 KB)
Criteria for Drugs Used in Pre-exposure Prophylaxis Trials against HIV Infection
Derdelinckx, I., Wainberg, M. A., Lange, J. M., et al. PLoS Medicine (2006), Vol. 3, p. e454.
This paper proposes criteria for deciding which medications should be used for pre-exposure prophylaxis (PrEP). Drug safety is a critical consideration because PrEP is given to healthy individuals for long-term prevention. Drugs used for PrEP must be potent against HIV, easy to use, cost-effective, and have a high barrier to resistance. Theoretically, drugs that interfere with HIV replication before the virus enters the host cell are preferable. An ideal PrEP drug would also have a unique resistance profile and not be used in treatment of established HIV infection, but such a medication does not yet exist.
View Full Study


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According to the National Foster Care Month website, there are more than
400,000 children and teens currently in the foster care system, and the
need for families to care for these young people is great. May is National Foster Care Month, a time to recognize foster parents for their extraordinary work with this nation's foster children. It is also a time to recognize how difficult life is for most foster children when they are taken from their families and schools and placed in new households for temporary or permanent stays. Finally, it is a time to note the efforts of the professionals who work in foster care, recruiting and training foster families, placing children in good homes, providing support and treatment to foster children and always being available to foster parents if a problem arises.
KidsPeace is committed to helping find permanency for foster children, which is in line with federal and state guidelines. We are also committed to helping foster teens make the transition from foster care to independence when they age out of the system at 18. We provide life skills training programs to older foster kids to help them prepare to find a job and an apartment, buy, register and insure a car, open and track a checking account, pay bills on time and learn many other skills that help them face life on their own. KidsPeace also ensures that foster children receive the mental health and tutoring services they need to be successful in foster placement.
KidsPeace carefully matches each child to a family that will best suit their needs and with which he or she will be a good fit. It is extremely hard on children to be moved from one house to another until a good match is made. "The federal mandate is to reduce 'drift,' which means kids being placed in home after home, which is very damaging to their ability to attach and their self-esteem. It is therefore the job of organizations such as ours to be extremely selective when interviewing potential foster families and providing them with in-depth training and support to deal with any crises that arise, 24/7," according to Foster Care and Family Services Regional Director for KidsPeace Ken Olson. "At KidsPeace, we do everything in our power to make our placements successful. We want our kids to stay in one foster home until they are returned to their families or are adopted, often by their foster families."
You are never alone if you join the KidsPeace Foster Care team. Our training is extensive, we are always there to help you and your foster child and you become a member of our Foster Care Community, where you will meet other foster parents, participate in KidsPeace sponsored events and know that you are a vital member of the child's foster care team. We often have sibling groups that will be so happy if a family takes them in together. KidsPeace especially encourages you to agree to take in a teen to guide to adulthood.If you have ever thought about what it might be like to be a foster parent, please take step toward foster parenting this May. KidsPeace invites the you to consider becoming a foster parent by reviewing these questions: 1. Would you like to make a difference in the life of a child in need? 2. Can you open your home to a foster child who has been closely matched with the dynamics of your family?3. Are you loving, patient, understanding, nonjudgmental and warm, and do you respect each child as an individual?4. Would you like to be treated as a full member of the professional team focused on your child's best interest?5. Can you provide your foster child with a safe environment that allows privacy and personal space? 6. Are you over 21? 7. Do you have a source of earned income that is sufficient to support your family?8. Do you have a fully insured automobile and the time to transport your foster child to appointments, activities and family visitations? 9. Are you available to attend extensive training about foster parenting?10. Do you have a background that is free of crime against children?If you answered yes to all of these questions, you may be eligible to become a foster parent. For more information, visit KidsPeace Foster Care at Fostercare.com.

subset: commoncrawl


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It's been a blast!
But unfortunately, Blighty has now closed down.
If you would like to watch incredible wildlife, history and other factual programming like the ones we were so proud to show, please head over to Eden (Sky 532 & Virgin 208) or Yesterday (Freeview 19, Sky 537 & Virgin 203).


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Trever Thornton-Payne was born January 12, 2011 in Talihina to John Rousseau and Julie Ann Payne. He passed from this life on March 14, 2012 in Antlers at the age of 14 months. Trever was a precious little boy. He loved horses, especially Blaze, and Jax, his Blue Heeler that always kept him out of trouble. He was truly loved and will be missed by everyone who knew him. He is survived by his parents: John & Julie of the home; sisters: Jessica Payne and Rebekah R. of Moyers; brother: Payton Neal of Moyers; many cousins, friends, and other relatives.
An Oklahoma teen becomes addicted to tobacco every 95 minutes, due in large part to the tobacco industry's decades-long practice of targeting young people through crafty advertising.
More than 90 percent of surveyed tobacco users said they started as teenagers, and the state figures mirror national findings released this month in a U.S. Surgeon's General report on tobacco use among youths and young adults.
Surgeon General Regina Benjamin started her report summary with a blunt conclusion: "Nearly all tobacco use begins during youth and young adulthood."
Antlers received $100,136 in sales tax disbursements in February, an increase over the $95,522 received in February of last year. Antlers also received a use tax disbursement of $5,352 in February, down from the $6,184 received in February of last year.
Clayton received a $40,416 sales tax disbursement in February, up from the $29,059 received in February of 2011.
Rattan received a sales tax disbursement of $1,530 in February, a decrease from the $2,116 received last February.
All last week the Pushmataha County Courthouse played host to the second of four trials of individuals charged with the murder of Robert Strickland of Hugo. This crime took place in April of 2010 and crime scenes were located in Choctaw, McCurtain and Pushmataha Counties. Twelve O.S.B.I. Agents and over 30 law enforcement officers, belonging to multiple agencies in the three counties, were involved in these investigation.
Signaling a changing of the seasons, Mother Nature battered north Texas and much of eastern Oklahoma on Monday and Tuesday, creating flooding conditions in many areas. Including Dumpling Creek, near Antlers on Ethel Road, where an unfortunate motorist got swept away in the rising water.
The Bearcats split a double header Friday night picking up a win against Clayton and a loss to Atoka.
Starting out against the Bulldogs in the 1st inning with two catches by center fielder, Chandon Draper and a strike out by pitcher Dakota Turner the Bearcats were off to a good start. Offensively the Bearcats would score 3 runs with a double hit by Bryce Martin and single from Turner, Drew McKnight, and Arizona Taylor. Draper would draw a walk.
On the evening of March 17, 2012, a new Miss RHS was chosen after a magnificent night full of excitement! Mrs. Dana House, Principal at Rattan School, welcomed everyone to the 21st Annual Miss RHS Scholarship Pageant. The show opened with the contestants and reigning Miss RHS 2012, Carleigh Crowley, thrilling the audience by performing a dance to "Runway".
The new Miss RHS 2012 is Miss Stepheney Haddox, a freshman and the daughter of Mark and Becky Rosa and Steve Haddox. She was escorted by Landon Carper, a junior and the son of Bill Carper and Chrystal Carper.
The Pushmataha County 4-H held its annual Speech and Demonstrations contest on Wednesday, March 14th at the United Methodist Church in Antlers. Seventy one 4-Her's participated in the contest. New county officers were also voted in.
The new officers are: Kat Bailey, Song Leader, Trey Greer, Game Leader, Tyanna Thurman, Recreational Leader, Will Lewis, Reporter, Tiffany Noel, Treasurer, Lindsay Hedrick, Secretary, Colby Watts, Co Vice-President, Dillon Hembree, Co Vice-President and Brandon Alford, President.
The Rattan Rams Junior High Baseball Team won 1st Place in the Valliant Junior High Baseball Tournament held on March 1st - 3rd. During the tournament, the team defeated Valliant, Lukfata and Broken Bow.
The basketball court is not the only place the Lady Rams succeeded this season. They're also doing quite well in the classroom. Rattan's varsity girls basketball team was recognized as the academic state champions for Class 2A. The ceremony took place on championship Saturday March 10 at State Fair Arena. Rattan boasted a GPA of 3.96 for the first semester. That honor shouldn't come as much of a surprise, though. The Lady Rams were also named academic state champions for the spring 2011 slow-pitch softball season and 2011 fall fast-pitch season.


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New art faculty exhibit runs through Feb. 23
The work "Painting" from Adrienne Callander's current project, Ball Series.
New faculty in Mississippi State's Department of Art are showcasing their artwork during an exhibition running through Feb. 23.
Titled "New Associations: Works by New Faculty in the Department of Art," the show in the gallery in McComas Hall will feature works by Adrienne Callander, Neil Callander, Gregory Martin and Suzanne Powney.
Adrienne Callander is the department's most recent addition as a lecturer in 2-D design and art appreciation. She graduated with a bachelor's degree from Reed College in Portland, Ore., a post-baccalaureate from Maryland Institute College of Art and a master's from the Mason Gross School of the Arts at Rutgers University.
Before becoming foundations coordinator and the drawing, painting and design assistant professor at MSU, Neil Callander taught painting and drawing at the University of Louisville and Indiana University Southeast. Callander received his bachelor's degree from Indiana University and his master's from the Mason Gross School of the Arts at Rutgers University. His work has shown in the 2011 WaterTower Regional, the 2011 Paint Snob Invitational in Waco, Texas, and First Look at the New Jersey Center for Contemporary Art.
Martin, assistant professor of drawing and design, received his bachelor's degree in illustration from CSU Long Beach and his master's in painting from Claremont Graduate School. Previously, Martin was a visiting lecturer at Otis College of Art and Design, USC Roski School of Fine Art, and U.C. San Diego Visual Arts.
MSU's new assistant professor of letterpress, graphic design and advertising, Powney received her master's degree from the University of Houston. Her works have exhibited as part of a group show at the University of Houston's Blaffer Art Museum, and she has been a member of the Museum of Printing History Printers Guild and the American Institute of Graphic Design of Houston. She also is the letterpress printer and operator for BlackDog Letterpress.
For more information about the exhibit, contact the art department at 662-325-2970.
Margaret Kovar | University Relations


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ROCKSPRINGS — "Victory for Meigs County, victory for the State of Ohio, and victory for Appalachia."
That was one of the statements made by Congressman Bill Johnson on Friday morning in reference to the new Meigs Emergency Room Facility.
Congressman Johnson joined many local and state officials at the official groundbreaking ceremony for the facility at 41861 Pomeroy Pike near Pomeroy. Dozens of local residents and current Holzer employees were also in attendance for the ceremony.
The facility will be operated by Holzer Health System and is being constructed through a collaborative effort with the Meigs County Community Improvement Corporation (CIC).
Paul Reed, President of the CIC, welcomed all of those in attendance and recognized many of the those in attendance who have played a role in making the long awaited facility a reality.
A constant theme among the speakers was of the time that has been put into making the facility happen and the need for such a facility in Meigs County.
Joy Padgett, assistant director for the Governor's Office of Appalachia seemed to sum it up best, saying it was an "example of patience and perseverance."
Speakers at the ceremony included Representative Debbie Phillips, Commissioner Randy Smith, Director of the Ohio Development Services Agency David Goodman, Chairman of the Board of Holzer Health Systems Brent Saunders, and Holzer Health Systems Chief Executive Officer T. Wayne Munro, MD.
Johnson referred to the work to bring an emergency facility to Meigs County as a "real example of national, state and local government and private sector innovation working together to make something happen.
Reed also noted the involvement of Mick Davenport, former Meigs County Commissioner, stating that Davenport dedicated his service to improving the health care available in Meigs County.
The work of Perry Varnadoe, Meigs County Economic Development Director, was also noted by Reed. He stated that without the work of Varnadoe these thing would not be happening today.
Phillips stated the facility had been a long time in the making, adding that for those carrying the torch on the project, it had been like a relay race passed down from one to another. She noted Davenport and the late Charlie Wilson as some of those who had previously worked on the project to Perry Varnadoe and Paul Reed as those currently working toward the goal.
Reed also read a letter sent by State Senator Lou Gentile congratulating those involved on the groundbreaking of the project.
Commissioner Smith reflected back to 16 years ago when he graduated high school from Meigs, located just beyond where the new facility will sit.
Smith noted that the road used to stop in the area of the school and that none of the medical facilities were present, with the area an empty lot from which all of this is emerging.
"The facility will be a monumentally piece of the health care campus," said Smith.
The campus also includes Hopewell Health Center (formerly Family Healthcare) and the future Meigs County Emergency Operations Center. The emergency room and the operations center will be side by side with a helipad located between them. Hopewell Health Center is on the opposite side of the road.
As Reed introduced Munro and Saunders to give there remarks, Reed noted that this was the first major project of the combined Holzer Health System, and would provide emergency care to one of two counties in the state which does not currently have an emergency facility.
Saunders stated that Holzer is pleased to expand services to the area.
Munro noted the current facility for primary care and urgent care services as signs of Holzer Health System's current involvement in the county, while adding that they look forward to becoming more involved in the future.
Goodman presented both Holzer Health System and the CIC with a proclamation from the Governor's office for their efforts on the project.
Director of Chaplaincy Services Fred Williams, Ph.D., gave the invocation before the National Anthem and Pledge of Allegiance lead by Hal Kneen to open the ceremony.
Following the speakers, the official ground breaking was held.
The facility will be operated by Holzer Health System and is being established in a collaborative effort with the Meigs County Community Improvement Corporation (CIC).
The facility is expected to open in the fall of 2014 and create around 30 new full-time positions.
The facility will feature a 24-hour staffed emergency department, equipped with state-of-the-art equipment and a helipad.
The building, which has been designed by Don Dispenza of Panich and Noel, will include eight treatment rooms, one double trauma room, two triage rooms, lab, pharmacy, general radiation and CT suite, along with areas for public and staff.
Kinsale Corporation of Chester, Ohio, will be the contractor for the project.
The $6 million project is financed by Ohio Valley Bank, with the commissioners having previously approved a bond resolution for the project.
The facility project was also assisted by Buckeye Hills-Hocking Valley Regional Development District, the Governor's Office of Appalachia, Senators Sherrod Brown and Rob Portman, Congressman Bill Johnson, Ohio Senator Lou Gentile, and Ohio Representative Debbie Phillips.


text: Ideally warm the pot first with a splash of hot water. Use one teabag per cup and use freshly drawn water which is heated to around 80 degrees. You can either pour the water before it reaches boiling point or allow the water to sit for a few minutes afterwards. Allow to brew for 2-3 minutes according to taste. Should be drunk without milk.


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Wednesday, October 30, 2013
Justin Pelic rushed for two touchdowns and Steven Schlosser scored one as the Play It Again Sports Crusaders held off a resilient Cario White team 22-16 to capture the MPRD JV (12-13 year olds) Post Season Championship.
Pelic raced in from 41 yards out to put the Crusaders on the board first. However, Cario would answer and take an 8-6 halftime lead when Rhett Kafka scored on a 13-yard run and Kellan Noonan tacked on the extra point.
The Crusaders would mount a comeback in the second half when Pelic added his second touchdown on a 22-yard run and Schlosser barreled in from three yards out. Cario White did not quit though as Noonan hauled in a 48-yard touchdown from Jaxen Rogers in the final seconds, but the Crusaders recovered the onside kick and ran out the clock.
Coach Biggers and the Play It Again Sports Crusaders capped a perfect season as regular and post season champions with the win, while Coach Schaefer and the Cario White Comets finished as post season runners-up.
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Thursday, June 19, 2014
Soup, crackers, applesauce, beef jerky, coffee, baby food, cake mixes, charcoal and non-perishable items galore
People came from all over, battling traffic and long lines, to take part in the clearance sale that started this morning at the Piggly Wiggly warehouse in Jedburg.
I have enough applesauce for probably a year and it doesnt expire until June of next year! said shopper Sharron Sommerfeldt.
Store items have been discounted to up to 70 percent off and the sale continues through June 21 but only while supply lasts. Already on social media people are reporting the warehouse is nearly wiped clean.
Christy Boudolf, senior director of marketing and advertising with Piggly Wiggly Carolina, said early today that the warehouse was very limited with items and would likely be closing early. It will not be open Saturday.
On Thursday Boudolf said the warehouse sale made a big dent in a mere three hours; there were folks lined up early before the sale started at 10 a.m.
The turnout was larger than we had expected, she said.
Up to a mile of traffic piled up on Old Dairy Road and Newton Way, leading up to the warehouse. People were reportedly in line outside the warehouse for up to two hours, and were being let inside as buggies and carts became available for shopping.
By noon Boudolf estimated they had seen more than 500 shoppers.
Despite the lengthy wait people endured to get inside the building, Boudolf said things went smoothly.
Everybody has been patient, calm and things have been very orderly, she said.
Item options include groceries, cleaning supplies, general merchandise, health and beauty, frozen foods and cigarettes. All sales are final and the warehouse will not hold any items. Shoppers can pay with credit cards, debit cards and cash no checks, EBT or WIC will be accepted.
Boudolf said the first things they sold out on were bath tissue and paper towels.
When its gone, its gone, Boudolf said. Theres no replenishments.
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If you find a comment that is objectionable, please click "report abuse" and we will review it for possible removal. Please be reminded, however, that in accordance with our Terms of Use and federal law, we are under no obligation to remove any third party comments posted on our website. Read our full terms and conditions.
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It seems that EVERYONE is doing giveaways these days and I suppose it's about time I show you sweet readers a little giveaway love!
The other day I had you all ask me questions and one of those questions was about my all time favorite book which is:
Like I said in my answer, it's not the world's best written book or the world's most thought provoking book. But every time I read it I laugh out loud. And I could be having the world's worst day and it can cheer me up. PLUS it's about blogging!
So. I've decided it's about time that one of you lucky readers gets your hands on this book. How can you do that? Why, enter my giveaway, of course! Here's how:
Entry #1: Comment and tell me why YOU'RE weird.
Entry #2: Follow my blog (no I'm not looking for high numbers, folks, it's just another way for YOU to win).
Entry #3: Tweet OR blog about this giveaway (and let me know, of course).
All entries must be submitted by this Sunday January 17th at 11:59PM central time.I'll announce the winner on Monday the 18th.


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Don't forget to check your spam folder if you cannot find the email. For further assistance please contact us at email@example.com .Okay
maxwell's 9.13.34 llc
At Maxwell's 9.13.34 we believe the home expresses an individual's personality and style. Because of their heritage and craftsmanship, antiques are our specialty, and we marry them with the new for a fresh and eclectic result. Our offerings include furniture, accessories, stationery, books, and linens. We hope that you will enjoy our finds and select some of them as life-long partners on your quest to create not just your house, but your home.


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Varsity Outreach blog lists MSU Facebook at No. 3
January 15, 2013
The blog, Varsity Outreach, has listed Mississippi State's Facebook page at No. 3 on its "Most Engaging College Facebook pages of 2012." The authors said, "We wanted to highlight those colleges and universities that were the most successful at consistently engaging their fan bases on Facebook this past year."
Varsity Outreach has been involved in helping students navigate the college admission process for more than six years. They've worked with top brands and state organizations, powering college-related content and tools on their websites. They are experts in building engaging, high-quality online resources for college-bound teenagers.
To view the listing, click here.


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Country Music Scholar
Published:20 January 2006
Distinguished historian of country music Bill Malone is interviewed by Southern Spaces editorial board member Charles Reagan Wilson at the University of Mississippi in October 2005. Malone offers a brief perspective on the beginnings of his career and discusses themes in his work. Videography by Joe York, University of Mississippi.
Use the scroller to the right of the playlist to watch all eight parts of the talk.
About Bill Malone:
Bill Malone is Professor Emeritus of History at Tulane University. His books include Country Music, U.S.A.; Southern Music/American Music; Southern Culture and the Roots of Country Music; and Don't Get Above Your Raisin': Country Music and the Southern Working Class.
Copyright © 2006 by Bill Malone.


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Enjoy good luck when you wear this Good Luck Sterling Silver Four Leaf Clover Pendant Necklace! This necklace features a four leaf clover charm that measures 1 inch in either direction and weighs 4 grams, making it the perfect simple Sterling Silver Shamrock Necklace. Legend has it that the four leaves on the clover represent love, faith, hope and luck. Bring more of those four great things in your life with this lucky four leaf clover necklace will look great with our matching silver lucky charm bracelet.
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You may return or exchange your jewelry within 60 days of purchase if you are not satisfied with it. The jewelry must be returned in its original condition for a refund or exchange. Engraved, personalized, photo, monogram, name and initial, chocolate and clearance items are not returnable or exchangeable.


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Find hotels in Bracken using the list and search tools below. Search for cheap and discounted hotel and motel rates in or near Bracken, NV for your personal leisure or group travel. Explore the most favored Bracken, Nevada hotel and motel rooms. Browse the Bracken area hotels to find the perfect lodging! Please use the provided map of the Bracken hotels.The Bracken center is about the area of Rio all suite hotel and the area of Orleans Arena.
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I absolutely loved this. I added my own little flair to it by bringing the temp down too 350 and adding in some garlic salt with a touch of dried oregano leaves. The lower temp made it so that they were still nice and crunchy, but warm and delicious :) Even as a teenager I highly enjoyed this!
Lauren, Ledyard, CT


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The American College of Obstetricians and Gynecologists
American Diabetes Association
Canadian Diabetes Association
Women's Health Matters
Gestational diabetes. ACOG practice bulletin No. 30.
Obstet Gynecol.
Gestational diabetes mellitus (GDM). EBSCO DynaMed website. Available at:
Updated August 19, 2014. Accessed September 29, 2014.
Hillier TA, Pedula KL, Vesco KK, et al. Excess gestational weight gain: modifying fetal macrosomia risk associated with maternal glucose.
Obstet Gynecol.
How to treat gestational diabetes. American Diabetes Association website. Available at:
http://www.diabetes.org/diabetes-basics/gestational/how-to-treat-gestational.html. Updated April 29, 2014. Accessed September 29, 2014.
2/5/2009 DynaMed's Systematic Literature Surveillance
http://www.ebscohost.com/dynamed: Cheng YW, Chung JH, Kurbisch-Block I, Inturrisi M, Shafer S, Caughey AB. Gestational weight gain and gestational diabetes mellitus: perinatal outcomes.
Obstet Gynecol.
4/1/2011 DynaMed's Systematic Literature Surveillance
http://www.ebscohost.com/dynamed: Dhulkotia JS, Ola B, Fraser R, Farrell T.
Oral hypoglycemic agents vs insulin in management of gestational diabetes: a systematic review and metaanalysis.
Am J Obstet Gynecol.
3/17/2014 DynaMed's Systematic Literature Surveillance
http://www.ebscohost.com/dynamed: Luoto R, Laitinen K, et al. Impact of material probiotic-supplemented dietary counselling on pregnancy outcome and prenatal and postnatal growth: a double-blind, placebo-controlled study. Br J Nutr. 2010. Jun;103(12):1792-1799.
6/9/2014 DynaMed's Systematic Literature Surveillance
http://www.ebscohost.com/dynamed: Qin JZ, Pang LH, et al. Obstetric complications in women with polycystic ovary syndrome: a systematic review and meta-analysis. Reprod Biol Endocrinol. 2013;11:56
10/13/2014 DynaMed's Systematic Literature Surveillance
http://www.ebscohost.com/dynamed: Zhang C, Tobias DK, et al. Adherence to healthy lifestyle and risk of gestational diabetes mellitus: prospective cohort study. BMJ. 2014 Sep 30;349.
This content is reviewed regularly and is updated when new and relevant evidence is made available. This information is neither intended nor implied to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with questions regarding a medical condition.
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Admissions & Financial Aid
Kent State University Ashtabula is an open-enrollment institution. Students who possess the minimum of a high school diploma or its equivalent may enroll for classes.
Te request information, fill in your email address in the box to the right.
The Admissions Office is here to help you through the process of being admitted to the Ashtabula Campus. Admissions is located in the Student Services Office in Main Hall.


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Your goal is a financially secure and comfortable retirement. Our goal is to get you there by helping you accumulate wealth for retirement and generate income in retirement. Find out how you can take charge of your retirement.
If retirement is on your horizon, here are 10 things you should do now.
Can I realistically retire at 58 and maintain my present lifestyle without touching the $2 million principal?
People used to retire at 62, and were dead by 65. That norm is changing thanks to the Age Wave.
Only Social Security for Retirement? That's a Paycut of Up to 70%
Are Target-Date Funds Off the Mark?
How to Start Saving for Retirement at 40
The Notion of Traditional Retirement Is Disappearing
A frequent question in retirement planning is if an IRA should be converted to a Roth. Get Ric's advice.
Learn why you should be cautious when rolling over your workplace retirement plan into an IRA.
The rules on RMDs are complex. Learn about the 4 biggest traps before you get caught in one.
Is Your 401(k) Safe?
The Biggest Issues with Workplace Retirement Plans
When Should You Start Contributing to Your 401(k)?
New British Law: What Not to Do with Your Pension
Are you wondering if you need a will, or how to make a will? Learn the basics about wills, and what happens if you don't have one.
What is a trust? How does it differ from a will? Which one is better for you? Watch this video to find out.
Parents often make the same mistake when naming beneficiaries of IRAs or life insurance policies. Learn the solution.
Should You Create a Trust?
One Simple Way to Prevent Your Heirs from Fighting
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The Cost of Creating a Trust