A randomized trial of the intrauterine contraceptive device vs hormonal contraception in women who are infected with the human immunodeficiency virus. A family planning intervention to reduce vertical transmission of HIV in Rwanda.
The purpose of this study was to determine whether the intrauterine contraceptive device (IUD) is effective and safe among women who are infected with the human immunodeficiency virus (HIV).
                We randomly assigned 599 postpartum, HIV-infected women in Zambia to receive either a copper IUD or hormonal contraception and followed them for at least 2 years.
                Women who were assigned randomly to hormonal contraception were more likely to become pregnant than those who were assigned randomly to receive an IUD (rate, 4.6/100 vs 2.0/100 woman-years; hazards ratio, 2.4; 95% CI, 1.3-4.7). One woman who was assigned to the IUD experienced pelvic inflammatory disease (crude rate, 0.16/100 woman-years; 95% CI, 0.004-868); there was no pelvic inflammatory disease among those women who were assigned to hormonal contraception. Clinical disease progression (death or CD4+ lymphocyte count dropping below 200 cells/microL) was more common in women who were allocated to hormonal contraception (13.2/100 woman-years) than in women who were allocated to the IUD (8.6/100 woman-years; hazard ratio, 1.5; 95% CI, 1.04-2.1).
                The IUD is effective and safe in HIV-infected women. The unexpected observation that hormonal contraception was associated with more rapid HIV disease progression requires urgent further study. Since contraception is an effective way of preventing the vertical transmission of HIV, we evaluated the impact of a family planning intervention on hormonal contraceptive use and incident pregnancy in a group of HIV-positive and HIV-negative urban Rwandan women.
                In a longitudinal cohort study, 502 women who were not pregnant or infertile and who had been previously HIV tested and counseled viewed an informational video about hormonal contraception followed by a facilitated discussion. They were given access to oral or injectable hormonal contraception and Norplant at the research clinic; those who used these methods were seen every 3 months.
                Of the 330 HIV-positive and 172 HIV-negative women who underwent the intervention, 120 either became new hormonal method users (n = 40), continued their previous use of a hormonal method (n = 64), or switched to another hormonal method (n = 16) following the intervention. There was a shift to use of longer lasting hormonal methods, and the annualized attrition rate was < 15%, compared to > 50% prior to the intervention. Rates of oral and injectable contraceptive use were similar among HIV-positive and HIV-negative women. Nine per cent of HIV-positive women became pregnant in the year after the intervention compared to 22% in a prior 12 month period when contraceptives were not provided at the study site. The corresponding proportions for HIV-negative women were 20% after the intervention versus 30% before the intervention.
                Access to and information about hormonal contraceptives resulted in increased use and reduced attrition among both HIV-positive and HIV-negative women in this study. The reduction in incident pregnancy was greatest among HIV-positive women, suggesting that factors other than access to hormonal contraceptives may have influenced fertility outcomes. Knowledge of HIV serostatus may have an important influence on family planning decisions.
In the populations studied, the IUD was more effective than hormonal contraception with respect to pregnancy prevention. High quality research is urgently needed to compare the effects, if any, of these two commonly used contraception methods on HIV acquisition/seroconversion and HIV/AIDS disease progression.