Background Women in biomedical HIV prevention clinical trials are frequently counselled to use effective contraceptive methods in order to avoid pregnancy during the study and consequent withholding of study products. Moreover, research study participants often have access to medical care at research clinics that might not otherwise be as readily available in their communities. We evaluated change in contraceptive use among women after exiting from a biomedical HIV prevention clinical trial in Kenya.
Methods The Partners in Prevention HSV/HIV Transmission Study enrolled HIV serodiscordant couples at 14 sites in East Africa and Southern Africa, including a site in Thika, Kenya. Participants were offered contraception free-of-charge at the research site during the clinical trial. Unblinding visits, at which the results of the trial were conveyed to participants, were conducted after the trial results were reported. Contraceptive use data were collected at the trial exit visit and at the later study unblinding visit.
Results Among 213 women from Thika in the trial, 114 returned for the unblinding visit, of whom 80 (70.2%) were HIV positive. The median time between exit and the unblinding visit was 1.11 years (ranging from 0.84—to 2.13 years). Non-barrier contraceptive prevalence (ie, use of oral, injectable, implantable contraceptives, intrauterine devices [IUD] or surgical) dropped from 62.3% to 47.4% (p=0.01) between exit and unblinding visits: from 70.0% to 53.8%, (p=0.03) among HIV positive women and from 44.1% to 32.4%, (p=0.31) among HIV negative women. However, the prevalence of IUD use among the HIV positive women increased from 3.8% to 20%, (p=0.002) during this period. Additionally, the proportion of women who were using condoms as their sole contraceptive method decreased, from 29% at study exit to 1.8% at the unblinding visit (p<0.0001), resulting in greater numbers of women who were not using any contraceptive method.
Conclusions There was a high rate of contraceptive discontinuation, both hormonal and barrier methods, after women exited from a biomedical HIV prevention trial. Discontinuation of contraception may reflect participant fertility desires after trial procedures are completed, or may reflect loss of clinical and counselling services available during the study. Innovative strategies to support the contraceptive needs of women after exiting HIV prevention trials are urgently needed.
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