BACKGROUND Preexposure prophylaxis with antiretroviral drugs has been effective in the prevention of human immunodeficiency virus (HIV) infection in some trials but not in others. METHODS In this randomized, double-blind, placebo-controlled trial, we assigned 2120 HIV-negative women in Kenya, South Africa, and Tanzania to receive either a combination of tenofovir disoproxil fumarate and emtricitabine (TDF–FTC) or placebo once daily. The primary objective was to assess the effectiveness of TDF–FTC in preventing HIV acquisition and to evaluate safety. RESULTS HIV infections occurred in 33 women in the TDF–FTC group (incidence rate, 4.7 per 100 person-years) and in 35 in the placebo group (incidence rate, 5.0 per 100 person-years), for an estimated hazard ratio in the TDF-FTC group of 0.94 (95% confidence interval, 0.59 to 1.52; P = 0.81). The proportions of women with nausea, vomiting, or elevated alanine aminotransferase levels were significantly higher in the TDF–FTC group (P = 0.04, P<0.001, and P = 0.03, respectively). Rates of drug discontinuation because of hepatic or renal abnormalities were higher in the TDF–FTC group (4.7%) than in the placebo group (3.0%, P = 0.051). Less than 40% of the HIV-uninfected women in the TDF–FTC group had evidence of recent pill use at visits that were matched to the HIV-infection window for women with seroconversion. The study was stopped early, on April 18, 2011, because of lack of efficacy. CONCLUSIONS Prophylaxis with TDF–FTC did not significantly reduce the rate of HIV infection and was associated with increased rates of side effects, as compared with placebo. Despite substantial counseling efforts, drug adherence appeared to be low. (Supported by the U.S. Agency for International Development and others; FEM-PrEP ClinicalTrials.gov number, NCT00625404.)

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Summary Background Identifying interventions to increase men’s uptake of HIV testing in sub-Saharan Africa is essential for the success of combination HIV prevention. HIV self-testing is an emerging approach with high acceptability, but limited evidence exists on optimal strategies for distributing self-tests. We explored a novel approach of providing multiple self-tests to women at high risk of HIV acquisition in order to promote partner HIV testing and facilitate safer sexual decision-making. Methods HIV-uninfected women aged 18–39 years were recruited at two sites in Kisumu, Kenya: a health facility with antenatal (ANC) and postpartum (PPC) clinics, and a drop-in center for female sex workers (FSW). Following informed consent and instructions on using the OraQuick Rapid HIV 1/2 Test, index participants (IPs) enrolled at the health facility and drop-in center received 3 and 5 self-tests, respectively. Structured interviews were conducted with IPs at enrollment and over 3 months to determine how self-tests were used. Key outcomes included the number of self-tests distributed by IPs, the proportion of IPs whose sexual partners used a self-test, couples testing, and sexual behavior following self-testing. Findings Between January 14, 2015 and March 13, 2015, 280 IPs were enrolled (61 ANC, 117 PPC, 102 FSW). Follow-up interviews were completed with 265 IPs (96%). Most IPs with a primary sexual partner distributed a self-test to that partner (53/58, 91% ANC; 91/106, 86% PPC; 64/85, 75% FSW). A vast majority of FSW IPs also distributed ≥1 self-tests to commercial sex clients (82/101, 81%). Among self-tests distributed to and used by IPs’ primary sexual partners, couples testing occurred frequently (27/53, 51% ANC; 62/91, 68% PPC; and 53/64; 83% FSW). Among self-tests distributed to and used by IPs’ sexual partners, an HIV-positive result was obtained for 3.8% (2/53), 2.2% (2/91), and 13.8% (41/298) of the tests in the ANC, PPC, and FSW participant groups, respectively. Sexual intercourse was significantly less likely after a sexual partner tested HIV-positive versus HIV-negative (18% vs. 62%, p<0.0001), while condom use was significantly more likely (100% vs. 44%, p=0.0018). Of 265 IPs with follow-up data, four reported intimate partner violence as a result of self-test distribution. No other adverse events were reported. Interpretation Provision of multiple HIV self-tests to women at high risk of HIV infection was successful in promoting HIV testing among their sexual partners and in facilitating safer sexual decisions. This novel strategy warrants further consideration as countries develop self-testing policies and programs.

BackgroundAchieving higher rates of partner HIV testing and couples testing among pregnant and postpartum women in sub-Saharan Africa is essential for the success of combination HIV prevention, including the prevention of mother-to-child transmission. We aimed to determine whether providing multiple HIV self-tests to pregnant and postpartum women for secondary distribution is more effective at promoting partner testing and couples testing than conventional strategies based on invitations to clinic-based testing.Methods and FindingsWe conducted a randomized trial in Kisumu, Kenya, between June 11, 2015, and January 15, 2016. Six hundred antenatal and postpartum women aged 18–39 y were randomized to an HIV self-testing (HIVST) group or a comparison group. Participants in the HIVST group were given two oral-fluid-based HIV test kits, instructed on how to use them, and encouraged to distribute a test kit to their male partner or use both kits for testing as a couple. Participants in the comparison group were given an invitation card for clinic-based HIV testing and encouraged to distribute the card to their male partner, a routine practice in many health clinics. The primary outcome was partner testing within 3 mo of enrollment. Among 570 participants analyzed, partner HIV testing was more likely in the HIVST group (90.8%, 258/284) than the comparison group (51.7%, 148/286; difference = 39.1%, 95% CI 32.4% to 45.8%, p < 0.001). Couples testing was also more likely in the HIVST group than the comparison group (75.4% versus 33.2%, difference = 42.1%, 95% CI 34.7% to 49.6%, p < 0.001). No participants reported intimate partner violence due to HIV testing. This study was limited by self-reported outcomes, a common limitation in many studies involving HIVST due to the private manner in which self-tests are meant to be used.ConclusionsProvision of multiple HIV self-tests to women seeking antenatal and postpartum care was successful in promoting partner testing and couples testing. This approach warrants further consideration as countries develop HIVST policies and seek new ways to increase awareness of HIV status among men and promote couples testing.Trial RegistrationClinicalTrials.gov NCT02386215.

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