Randomized assignment to copper IUD or depot-medroxyprogesterone acetate: feasibility of enrollment, continuation and disease ascertainment. A randomized trial of the intrauterine contraceptive device vs hormonal contraception in women who are infected with the human immunodeficiency virus.
We conducted a feasibility study to enroll and follow family planning acceptors who were randomly assigned to use an intrauterine device (IUD) or injectable depot-medroxyprogesterone acetate (DMPA).
                Centers in Brazil, Guatemala, Egypt and Vietnam aimed to enroll 100 participants per site. Enrolled women were randomly assigned to have inserted a TCu 380A IUD, or to receive injections of 150 mg of DMPA every 3 months, and scheduled for up to 12 months of follow-up. We tested for cervical infection at first and final visits, and examined for signs of pelvic inflammatory disease (PID) at each visit.
                The sites screened 555 women and enrolled 368. Two women (0.5%) had three discomfort signs of PID during follow-up. The prevalence of gonorrhea at each woman's final follow-up visit was 0.5%, and the prevalence of chlamydia at final visit was 5.4%. Sixty-eight percent of women either completed 12 months of observation with their assigned method or were still using their method at the end of the study.
                A larger, definitive clinical trial appears feasible. The majority of women we approached agreed to participate; nearly 400 women were enrolled; two thirds continued to use their assigned method until study closeout; and the STI risk was moderate. 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.
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.