Condom and nonoxynol-9 use and the incidence of HIV infection in serodiscordant couples in Zambia. Efficacy of an HIV prevention intervention for African American adolescent girls: a randomized controlled trial. Efficacy of sexually transmitted disease/human immunodeficiency virus sexual risk-reduction intervention for african american adolescent females seeking sexual health services: a randomized controlled trial. A longitudinal study of human immunodeficiency virus transmission by heterosexual partners. European Study Group on Heterosexual Transmission of HIV. Behavioral intervention to increase condom use among high-risk female adolescents. Condom use after voluntary counselling and testing in central Mozambique. All4You! A randomized trial of an HIV, other STDs, and pregnancy prevention intervention for alternative school students. A brief, low-cost, theory-based intervention to promote dual method use by black and Latina female adolescents: a randomized clinical trial. Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial. A tailored minimal self-help intervention to promote condom use in young women: results from a randomized trial. The efficacy of female condom skills training in HIV risk reduction among women: a randomized controlled trial. Abstinence and safer sex HIV risk-reduction interventions for African American adolescents: a randomized controlled trial. A randomized controlled trial to reduce HIV transmission risk behaviors and sexually transmitted diseases among women living with HIV: The WiLLOW Program. Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial.
We aimed to measure the effectiveness of latex condoms and of nonoxynol-9 [N-9] spermicides, in preventing HIV transmission in heterosexual serodiscordant couples in Lusaka. Each couple was examined at clinic visits scheduled at 3-month intervals for one year or more per couple, or until seroconversion or discontinuation. Couples were given condoms and their choice of 3 N-9 products and advised to use both at every intercourse. Sexual exposure was ascertained from coital logs that recorded coitus and barrier method use. HIV serological testing was done at each clinic visit (ELISA and Western blot if positive). One hundred and ten discordant couples were followed for a mean of 17.6 months. Seventy-eight per cent of coital episodes were protected by condoms, 85% by spermicides and 6.4% were unprotected. Fourteen seroconversions occurred (8.7 infections per 100 couple-years [c-y]). The rate was higher among seronegative men than seronegative women. Among couples who reported using condoms at every intercourse the infection rate was 2.3/100 c-y, compared with 10.7/100 c-y among couples using condoms less consistently (rate ratio [RR] 0.2; 95% confidence interval [CI] 0-1.6). Among couples who reported using N-9 at every intercourse, the seroconversion rate was 6.9/100 c-y; among couples who reported less than full-time N-9 use, the rate was 8.9/100 c-y (RR 0.8; 95% CI 0.2-2.8). Among the subset of female seronegatives, the N-9 RR was 0.5 (95% CI 0.1-3.8). But when we calculated HIV rates according to N-9 consistency in coital acts when condoms were not used, there was no evidence of protection with higher N-9 use. Consistent use of latex condoms reduces the incidence of HIV infection, but the association between N-9 spermicides and HIV is less clear. The current study could not provide compelling data on the impact of N-9 spermicide use on risk of HIV infection. The study's small size, as well as the consistency of concurrent condom use, limited our inferences. Available spermicide products must be studied further. African American adolescent girls are at high risk for human immunodeficiency virus (HIV) infection, but interventions specifically designed for this population have not reduced HIV risk behaviors.
                To evaluate the efficacy of an intervention to reduce sexual risk behaviors, sexually transmitted diseases (STDs), and pregnancy and enhance mediators of HIV-preventive behaviors.
                Randomized controlled trial of 522 sexually experienced African American girls aged 14 to 18 years screened from December 1996 through April 1999 at 4 community health agencies. Participants completed a self-administered questionnaire and an interview, demonstrated condom application skills, and provided specimens for STD testing. Outcome assessments were made at 6- and 12-month follow-up.
                All participants received four 4-hour group sessions. The intervention emphasized ethnic and gender pride, HIV knowledge, communication, condom use skills, and healthy relationships. The comparison condition emphasized exercise and nutrition.
                The primary outcome measure was consistent condom use, defined as condom use during every episode of vaginal intercourse; other outcome measures were sexual behaviors, observed condom application skills, incident STD infection, self-reported pregnancy, and mediators of HIV-preventive behaviors.
                Relative to the comparison condition, participants in the intervention reported using condoms more consistently in the 30 days preceding the 6-month assessment (unadjusted analysis, intervention, 75.3% vs comparison, 58.2%) and the 12-month assessment (unadjusted analysis, intervention, 73.3% vs comparison, 56.5%) and over the entire 12-month period (adjusted odds ratio, 2.01; 95% confidence interval [CI], 1.28-3.17; P =.003). Participants in the intervention reported using condoms more consistently in the 6 months preceding the 6-month assessment (unadjusted analysis, intervention, 61.3% vs comparison, 42.6%), at the 12-month assessment (unadjusted analysis, intervention, 58.1% vs comparison, 45.3%), and over the entire 12-month period (adjusted odds ratio, 2.30; 95% CI, 1.51-3.50; P<.001). Using generalized estimating equation analyses over the 12-month follow-up, adolescents in the intervention were more likely to use a condom at last intercourse, less likely to have a new vaginal sex partner in the past 30 days, and more likely to apply condoms to sex partners and had better condom application skills, a higher percentage of condom-protected sex acts, fewer unprotected vaginal sex acts, and higher scores on measures of mediators. Promising effects were also observed for chlamydia infections and self-reported pregnancy.
                Interventions for African American adolescent girls that are gender-tailored and culturally congruent can enhance HIV-preventive behaviors, skills, and mediators and may reduce pregnancy and chlamydia infection. To evaluate the efficacy of an intervention to reduce incident sexually transmitted disease (STD) and enhance STD/human immunodeficiency virus (HIV)-preventive behaviors and psychosocial mediators.
                A randomized controlled trial of an HIV prevention program.
                Clinic-based sample in Atlanta, Georgia.
                African American adolescent females (N = 715), aged 15 to 21 years, seeking sexual health services. Participants completed an audio computer-assisted self-interview and provided self-collected vaginal specimens for STD testing. Intervention Intervention participants received two 4-hour group sessions and 4 telephone contacts over a 12-month period, targeting personal, relational, sociocultural, and structural factors associated with adolescents' STD/HIV risk, and were given vouchers facilitating male partners' STD testing/treatment. Main Outcome Measure Incident chlamydial infections.
                Over the 12-month follow-up, fewer adolescents in the intervention had a chlamydial infection (42 vs 67; risk ratio [RR], 0.65; 95% confidence interval [CI], 0.42 to 0.98; P = .04) or recurrent chlamydial infection (4 vs 14; RR, 0.25; 95% CI, 0.08 to 0.83; P = .02). Adolescents in the intervention also reported a higher proportion of condom-protected sex acts in the 60 days preceding follow-up assessments (mean difference, 10.84; 95% CI, 5.27 to 16.42; P < .001) and less frequent douching (mean difference, -0.76; 95% CI, -1.15 to -0.37; P = .001). Adolescents in the intervention were also more likely to report consistent condom use in the 60 days preceding follow-up assessments (RR, 1. 41; 95% CI, 1.09 to 1.80; P = .01) and condom use at last intercourse (RR, 1.30; 95% CI, 1.09 to 1.54; P = .005). Intervention effects were observed for psychosocial mediators of STD/HIV-preventive behaviors.
                Interventions for African American adolescent females can reduce chlamydial infections and enhance STD/HIV-preventive behaviors and psychosocial mediators of STD/HIV-preventive behaviors. Trial Registration clinicaltrials.gov Identifier: NCT00633906. Worldwide, the predominant mode of human immunodeficiency virus (HIV) transmission is heterosexual intercourse, but the risk of heterosexual transmission and the effectiveness of measures to prevent it are not well defined.
                We conducted a prospective study of HIV-negative subjects whose only risk of HIV infection was a stable heterosexual relationship with an HIV-infected partner. Every six months the subjects were interviewed, tested for HIV, and counseled about safe sexual practices.
                A total of 304 HIV-negative subjects (196 women and 108 men) were followed for an average of 20 months. During the study, 130 couples (42.8 percent) ended their sexual relationships, most often because of the HIV-infected partner's illness or death. Of the 256 couples who continued to have sexual relations for more than three months after enrollment in the study, only 124 (48.4 percent) used condoms consistently for vaginal and anal intercourse. Among these couples, none of the seronegative partners became infected with HIV, despite a total of about 15,000 episodes of intercourse. Among the 121 couples who used condoms inconsistently, the rate of seroconversion was 4.8 per 100 person-years (95 percent confidence interval, 2.5 to 8.4). Eleven couples refused to answer questions about condom use. The risk of transmission increased with advanced stages of HIV infection in the index partners (P < 0.02) and with genital infection in the HIV-negative partners (P < 0.04). Withdrawal to avoid ejaculation in the vagina had a protective effect in uninfected women (P < 0.02).
                Consistent use of condoms for heterosexual intercourse is highly effective in preventing the transmission of HIV. Among couples not using condoms regularly, the risk of HIV transmission varies widely. To determine whether condom use among high-risk female adolescents could be increased by a behavioral intervention, with the use of infection with Chlamydia trachomatis as a biomarker of condom practices.
                Prospective, randomized, controlled intervention.
                Urban family planning and sexually transmitted disease clinics.
                Two hundred nine female adolescents, aged 15 through 19 years, who were treated for C. trachomatis genitourinary infection, were randomly assigned to standard (control) or experimental (behavioral intervention) groups. One hundred twelve subjects returned for follow-up 5 to 7 months after enrollment and comprise the study subjects.
                Subjects completed a multiinstrument questionnaire measuring sexual behavior, condom practices, attitudes and beliefs, cognitive complexity, sociodemographics, and motivation at enrollment and follow-up. Endourethral and endocervical sites were sampled for C. trachomatis.
                Among the 112 subjects who returned for repeated examination, those who had received the experimental intervention reported increased use of condoms by their sexual partners for protection against sexually transmitted diseases (odds ratio = 2.4; p = 0.02) and for vaginal intercourse (odds ratio = 3.1; p = 0.005) at the 6-month follow-up. Multivariable logistic regression analysis controlling for condom use at enrollment demonstrated that the experimental intervention (odds ratio = 2.8; p = 0.03) and the higher cognitive complexity (odds ratio = 4.6; p = 0.02) independently contributed to greater condom use at follow-up. Despite greater use of condoms among the group who had received the intervention, use remained inconsistent and rates of reinfection with C. trachomatis were not significantly different (26% vs 17%; p = 0.3).
                Although a brief behavioral intervention among high-risk female adolescents can increase condom use by their sexual partners, incident infection does not appear to be reduced, because condom use remained inconsistent. To evaluate the efficacy of voluntary counselling and testing (VCT) for HIV/AIDS in changing risky sexual behaviour in central Mozambique.
                Longitudinal cohort study of men and women aged at least 18 years from October 2002 to June 2003. We interviewed 622 participants in VCT groups and 598 in non-VCT groups. The interviews occurred before counselling and 4 and 6 months afterwards.
                Reported use of condoms while having sex with a friends/prostitute increased over each time period in the VCT group and between baseline and first visit in the non-VCT group. Both men and women in the VCT group increased their condom use over time, but the women in the non-VCT group did not. Reported always/sometimes use of condoms for both literate and illiterate subjects was higher and rose over time in the VCT group.
                People who undergo voluntary counselling and testing fro HIV/AIDS change their behaviour, presumably as a result of their counselling. This study evaluated All4You!, a theoretically based curriculum designed to reduce sexual risk behaviors associated with HIV, other STDs, and unintended pregnancy among students in alternative schools. The study featured a randomized controlled trial involving 24 community day schools in northern California. A cohort of 988 students was assessed four times during an 18-month period using a self report questionnaire. At the 6-month follow-up, the intervention reduced the frequency of intercourse without a condom during the previous 3 months, the frequency of intercourse without a condom with steady partners, and the number of times students reported having intercourse in the previous 3 months. It also increased condom use at last intercourse. These behavioral effects were no longer statistically significant at the 12- and 18-month follow-ups. The All4You! intervention was effective in reducing selected sexual risk behaviors among students in alternative school settings; however, the effects were modest and short term. HIV/AIDS disproportionately affects young women of color. Young women who use hormonal contraception are less likely to use condoms. Brief, inexpensive HIV-prevention interventions are needed for high-volume clinics. This study was a randomized clinical trial of two interventions: (a) a video made for this study and (b) an adaptation of Project RESPECT counseling. Four hundred Black and Latina teenage women completed a questionnaire about their sexual behaviors and were randomly assigned to (a) see the video, (b) get counseling, (c) see the video and get counseling, or (d) receive usual care. At 3-month follow-up, those who saw the video and received counseling were 2.5 times more likely to have used a condom at last intercourse with their main partner than teens in the usual care group. These differences did not persist at 12-month follow-up. This suggests that a brief intervention can positively affect condom use in the short term. The male condom is the most effective barrier method available for protection against sexually transmitted diseases (STDs), including HIV infection. There is an urgent need to develop and evaluate other prevention methods, such as the female condom. This study estimated the additional protection against STDs offered to sex workers by giving them the option of using the female condom when clients refused to use a male condom.
                Sex establishments in four cities in Thailand were randomized into two study groups: one in which sex workers were instructed to use male condoms consistently (male condom group); and one in which sex workers had the option of using the female condom if clients refused or were not able to use male condoms (male/female condom group). Randomization was done by sex establishments, and not by individuals, to minimize sharing of female condoms across study groups. The proportion of unprotected sexual acts (defined as sexual acts in which condoms were not used, tore, or slipped in or out) and incidence rate of STDs (gonorrhoea, chlamydial infection, trichomoniasis and genital ulcer disease) were measured over a 24-week period and compared between the two study groups.
                Results are available from 34 sex establishments (249 women) in the male/female condom group, and 37 sex establishments (255 women) in the male condom group. Condom use was very high in both groups (97.9 and 97.3 % of all sexual acts, respectively, P > 0.05). Male condom use was lower in the male/female condom group when compared with the male condom group (88.2 and 97.5%, respectively, P < 0.001). However, this reduction in male condom use was counterbalanced by the use of female condoms in 12.0% of all sexual acts in the male/female condom group, contributing to a 17% reduction in the proportion of unprotected sexual acts in this group when compared to the male condom group (5.9 versus 7.1%, respectively, P = 0.16). Female condom use was sustained over the entire study period. There was also a 24% reduction in the weighted geometric mean incidence rate of STDs in the sex establishments of the male/female condom group compared to the male condom group (2.81 versus 3.69 per 100 person-weeks, P = 0.18). To evaluate the efficacy of a theory-based tailored minimal self-help intervention to increase condom use among young women at risk for HIV/sexually transmitted disease (STD).
                Randomized controlled trial on an intent-to-treat basis in two managed care plans, in Washington state and North Carolina, with follow-up at 3 and 6 months.
                A proactively recruited sample of 1210 heterosexually active, non-monogamous, non-pregnant women, aged 18-24 years recruited June 1999-April 2000; 85% completed the 6-month follow-up.
                Arm 1 received usual care. Arm 2 received a mailed computer-generated self-help magazine, individually tailored on survey items including stage of readiness to use condoms, barriers to condom use, partner type; condom samples and a condom-carrying case were included in the packet; this was followed 3 months later by a tailored 'booster' newsletter. The a priori 6-month main outcomes were percentage of women using condoms during the previous 3 months (overall and by partner type) and proportion of total episodes of intercourse during which condoms were used in the previous 3 months.
                Relative to usual care, intervention group women reported significantly more condom use overall [adjusted odds ratio (OR), 1.86; 95% confidence interval (CI), 1.32-2.65; P = 0.0005] and with recent primary partners (OR, 1.97; 95% CI, 1.37-2.86; P = 0.0003). They also reported using condoms for a higher proportion of intercourse episodes (52.7% versus 47.9%; P = 0.05). Significantly more intervention women carried condoms, discussed condoms with partners, and had higher self-efficacy to use condoms with primary partners.
                Tailored cognitive/behavioral minimal self-help interventions hold promise as HIV/STD prevention strategies for diverse populations of young at-risk women. We evaluated the efficacy of skills training designed to increase female condom use among women.
                We conducted a randomized controlled trial of 409 women, recruited from family planning clinics in northern California, who were randomly assigned to the experimental 4-session female condom skills training intervention or the comparison 4-session women's general health promotion intervention. Participants received condom use instructions at baseline and male and female condoms during the study. They completed audio computer-assisted self-interviews at baseline and at 3 and 6 months.
                At 3 and 6 months, women in the experimental group were more likely than those in the comparison group to have used the female condom at least once in the prior 3 months. The increase in the percentage of sexual acts protected by female condoms from baseline to the 6-month follow-up was greater for the experimental group. The percentage of sexual acts during which any condom was employed was higher in the experimental group at 6 months. There were no group differences in male condom use.
                Outcomes suggest that skills training can increase female condom use and protected sexual acts without reducing male condom use among women. African American adolescents are at high risk of contracting sexually transmitted infection with human immunodeficiency virus (HIV), but which behavioral interventions to reduce risk are most effective and who should conduct them is not known.
                To evaluate the effects of abstinence and safer-sex HIV risk-reduction interventions on young inner-city African American adolescents' HIV sexual risk behaviors when implemented by adult facilitators as compared with peer cofacilitators.
                Randomized controlled trial with 3-, 6-, and 12-month follow-up.
                Three middle schools serving low-income African American communities in Philadelphia, Pa.
                A total of 659 African American adolescents recruited for a Saturday program.
                Based on cognitive-behavioral theories and elicitation research, interventions involved 8 1-hour modules implemented by adult facilitators or peer cofacilitators. Abstinence intervention stressed delaying sexual intercourse or reducing its frequency; safer-sex intervention stressed condom use; control intervention concerned health issues unrelated to sexual behavior.
                Self-reported sexual intercourse, condom use, and unprotected sexual intercourse.
                Mean age of the enrollees was 11.8 years; 53% were female and 92.6% were still enrolled at 12 months. Abstinence intervention participants were less likely to report having sexual intercourse in the 3 months after intervention than were control group participants (12.5% vs 21.5%, P=.02), but not at 6- or 12-month follow-up (17.2% vs 22.7%, P=.14; 20.0% vs 23.1%, P=.42, respectively). Safer-sex intervention participants reported significantly more consistent condom use than did control group participants at 3 months (odds ratio [OR]=3.38; 95% confidence interval [CI], 1.25-9.16) and higher frequency of condom use at all follow-ups. Among adolescents who reported sexual experience at baseline, the safer-sex intervention group reported less sexual intercourse in the previous 3 months at 6- and 12-month follow-up than did control and abstinence intervention (adjusted mean days over prior 3 months, 1.34 vs 3.77 and 3.03, respectively; P< or =.01 at 12- month follow-up) and less unprotected intercourse at all follow-ups than did control group (adjusted mean days, 0.04 vs 1.85, respectively, P<.001, at 12-month follow-up). There were no differences in intervention effects with adult facilitators as compared with peer cofacilitators.
                Both abstinence and safer-sex interventions can reduce HIV sexual risk behaviors, but safer-sex interventions may be especially effective with sexually experienced adolescents and may have longer-lasting effects. To evaluate the efficacy of an intervention to reduce HIV transmission risk behaviors and sexually transmitted diseases (STDs) and enhance HIV-preventive psychosocial and structural factors among women living with HIV.
                A randomized controlled trial of 366 women living with HIV in Alabama and Georgia.
                The intervention emphasized gender pride, maintaining current and identifying new network members, HIV transmission knowledge, communication and condom use skills, and healthy relationships.
                Unprotected vaginal intercourse. OTHER OUTCOMES: Proportion never used condoms, incident STDs, psychosocial factors, and number of supportive network members.
                Over the 12-month follow-up, women in the WiLLOW intervention, relative to the comparison, reported fewer episodes of unprotected vaginal intercourse (1.8 vs. 2.5; P = 0.022); were less likely to report never using condoms (odds ratio [OR] = 0.27; P = 0.008); had a lower incidence of bacterial infections (Chlamydia and gonorrhea) (OR = 0.19; P = 0.006); reported greater HIV knowledge and condom use self-efficacy, more network members, fewer beliefs that condoms interfere with sex, and fewer partner-related barriers to condom use; and demonstrated greater skill in using condoms.
                This is the first trial to demonstrate reductions in risky sexual behavior and incident bacterial STDs and to enhance HIV-preventive psychosocial and structural factors among women living with HIV. To compare the contraceptive effectivenesses of a polyurethane condom and a standard latex condom. Secondary outcomes of interest were safety, functionality, discontinuation, and acceptability.
                We randomized 901 couples to use either the polyurethane condom or a standard latex condom as their only form of contraception. We tested for pregnancy at enrollment and at every scheduled follow-up visit (weeks 4, 10, 16, 22, and 30).
                The 6-month typical-use pregnancy probabilities were 9.0% (95% confidence interval [CI] 5.9, 12.2) for the polyurethane group and 5.4% (95% CI 2.9, 7.8) for the latex group; the hazard ratio was 1.7 (95% CI 1.1, 2.7), and we failed to reject the null hypothesis of our test of noninferiority. Females in the polyurethane group reported fewer genital irritations (hazard ratio 0.6; 95% CI 0.5, 0.8; P <.01), whereas males in both groups reported the same number of genital irritations (hazard ratio 1.0; 95% CI 0.7, 1.5; P =.94). Total clinical failures (breakage and slippage) were 8.4% for the polyurethane condom and 3.2% for the latex condom (difference 5.3%, 90% CI 2.8, 7.7). The risk of discontinuation did not differ between groups. Participants judged both condoms favorably in terms of the four primary acceptability outcomes (willingness to purchase, willingness to recommend, confidence in method, and general comfort).
                The polyurethane condom was not shown to be as effective as the latex comparator condom for pregnancy prevention. However, the risk of pregnancy in the polyurethane group falls in the range of other barrier methods. For people with latex sensitivity or who find latex condoms unacceptable, this polyurethane condom represents one of several synthetic male condom alternatives currently available on the US market.
This review indicates that consistent use of condoms results in 80% reduction in HIV incidence. Consistent use is defined as using a condom for all acts of penetrative vaginal intercourse. Because the studies used in this review did not report on the "correctness" of use, namely whether condoms were used correctly and perfectly for each and every act of intercourse, effectiveness and not efficacy is estimated. Also, this estimate refers in general to the male condom and not specifically to the latex condom, since studies also tended not to specify the type of condom that was used. Thus, condom effectiveness is similar to, although lower than, that for contraception.