CDC124 - Publication Only
FEM-PrEP: current status of a phase III trial of ARV for PrEP among higher risk African women
L. Van Damme1, A. Corneli2, K. Agot3, K. Ahmed4, J. Lombaard5, R. Manongi6, J. Hakim7, J. Deese2, D. Taylor2
1FHI, Clinical Sciences, Arlington, United States, 2FHI, Durham, NC, United States, 3Impact Research and Development Organization, Kisumu, Kenya, 4Setshaba Research Centre, Pretoria, South Africa, 5JOSHA Research, Bloemfontein, South Africa, 6Kilimanjaro Christian Medical Center, Moshi, Tanzania, United Republic of, 7UZ-UCSF Collaborative Research Programme, University of Zimbabwe, Harare, Zimbabwe
Background: FEM-PrEP is an ongoing PrEP trial.
Methods: FEM-PrEP is a placebo-controlled trial designed to assess the safety and effectiveness of daily oral Truvada in preventing HIV infection among higher-risk women in sub-Saharan Africa. Participants attend screening, enrollment and monthly follow-up visits (12 months on product), and are required to be using an effective contraceptive method at enrollment. Women who seroconvert are taken off product and followed for 12 months. Extensive behavioral research and community engagement activities support the trial.
Results: As of 31 January 2011, 3632 women were screened and 1912 enrolled (~50% of sample size) in Pretoria (SA); Bloemfontein (SA); Bondo (Kenya); and Arusha (Tanzania). Harare (Zimbabwe) had not begun enrollment. Common reasons for exclusion include existing HIV infection (N=693), medical conditions (N=326) mostly identified through lab testing, and not returning for enrollment (N=189).
At screening, 63% of women reported contraceptive use, with injectables (39%), oral contraceptives (8%), and condoms (13%) being most common. Reported sexual behavior is similar across sites with a mean of three vaginal sex acts, one partner and inconsistent condom use in the week prior to enrollment. Anal sex in the previous month was reported by 1.5% of women (2.6% in Bondo). Screening prevalence of N. gonorrheoea, C. trachomatis, trichomoniasis, bacterial vaginosis, and candidiasis was 5.6%, 13.8%, 5.5%, 42%, and 11.3%, respectively, and varies across sites.
Findings from focus groups with community stakeholders and in-depth interviews with trial participants suggest the trial is well accepted.
Conclusions: Results from the trial are expected late 2013.The relatively high screening prevalence of HIV makes recruitment a challenge. Approximately 10% of screened women were ineligible due to existing medical conditions. Any need to identify these before initiating PrEP may pose a challenge to future roll-out programs in resource constrained settings.
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