A randomized trial of the intrauterine contraceptive device vs hormonal contraception in women who are infected with the human immunodeficiency virus

OBJECTIVE: 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). STUDY DESIGN: 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. RESULTS: 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% Cl, 1.3- 4.7). One woman who was assigned to the IUD experienced pelvic inflammatory disease (crude rate, 0.16/100 woman- years; 95% Cl, 0.004- 868); there was no pelvic in- flammatory disease among those women who were assigned to hormonal contraception. Clinical disease progression (death or CD4+ lymphocyte count dropping below 200 cells/ mu L) 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% Cl, 1.04- 2.1). CONCLUSION: 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.