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.)

IntroductionThe customs of widow cleansing and widow inheritance are practiced in several communities throughout sub-Saharan Africa. In the Nyanza Province of Kenya, according to tradition, Luo widows are expected to engage in sexual intercourse with a “cleanser,” without the use of a condom, in order to remove the impurity ascribed to her after her husband's death. Luo couples, including widows, are also expected to engage in sex preceding specific agricultural activities, building homes, funerals, weddings, and other significant cultural and social events. Widows who are inherited for the purpose of fulfilling cultural obligation have a higher prevalence of HIV than those who remain un-inherited or are inherited for the purpose of companionship.MethodsAs part of a larger descriptive qualitative study to inform study procedures for FEM-PrEP, an HIV prevention pre-exposure prophylaxis clinical trial, we conducted 15 semi-structured interviews (SSIs) with widows, 15 SSIs with inheritors, and four focus group discussions with widows in the Bondo and Rarieda districts in Nyanza Province to explore the HIV risk context within widow cleansing and inheritance practices. Thematic qualitative analysis was used to analyze the data.ResultsThe majority of widows reported in the demographic questionnaire being inherited, and most widows in the SSIs described participating in the cleansing ritual. We identified two main themes related to HIV prevention within the context of widow cleansing and inheritance: 1) widows must balance limiting their risk for HIV infection with meeting cultural expectations and ensuring that their livelihood needs are met, and 2) sexual abstinence undermines cultural expectations in widowhood while the use of condoms is deemed inappropriate in fulfilling culturally prescribed sexual rituals, and is often beyond the widow's ability to negotiate.ConclusionsWomen-controlled HIV prevention methods such as antiretroviral-based oral pre-exposure prophylaxis, vaginal gels, and vaginal rings are needed for HIV-negative widows who engage in sexual rituals related to widowhood.

Whereas modern dietary advice emphasizes the importance of freshly preparing food, many African communities leave food to ferment. Fermentation of cereals is a traditional method of reducing the microbial contamination of porridges. Beliefs and consumption patterns of fermented food were examined among mothers of children aged under five and health workers in a rural and urban community in Kenya. The majority (83%) of rural mothers reported that their families regularly consumed fermented food and over half (66%) gave their young children fermented food. In the urban area, fewer mothers (56%) reported that their families ate fermented food and only (40%) gave their children some kind of fermented food. Several reasons for the declining uses of fermented food were given including education by health workers that fermented foods were bad, declining production and availability, and substitution of traditional foods by commercial products such as soft drinks. Health educators need to consider that mothers may be missing out on a potentially useful means of preventing diarrhoea in their children.

IntroductionUptake of voluntary medical male circumcision (VMMC) as an intervention for prevention of HIV acquisition has been low among men aged !25 years in Nyanza region, western Kenya. We conducted a baseline survey of the prevalence and predictors of VMMC among men ages 25-39 years as part of the preparations for a cluster randomized controlled trial (cRCT) called the Target, Speed and Coverage (TASCO) Study. The TASCO Study aimed to assess the impact of two demand creation interventions-interpersonal communication (IPC) and dedicated service outlets (DSO), delivered separately and together (IPC + DSO)-on VMMC uptake. MethodsAs part of the preparatory work for implementation of the cRCT to evaluate tailored interventions to improve uptake of VMMC, we conducted a survey of men aged 25-39 years from a traditionally non-circumcising Kenyan ethnic community within non-contiguous locations selected as study sites. We determined their circumcision status, estimated the baseline circumcision prevalence and assessed predictors of being circumcised using univariate and multivariate logistic regression. ResultsA total of 5,639 men were enrolled of which 2,851 (50.6%) reported being circumcised. The odds of being circumcised were greater for men with secondary education (adjusted Odds Ratio (aOR) = 1.65; 95% CI: 1.45-1.86, p<0.001), post-secondary education (aOR = 1.72; 95% CI: 1.44-2.06, p <0.001), and those employed (aOR = 1.32; 95% CI: 1.

To meet the reproductive health needs of women, especially those in sub-Saharan Africa, multipurpose prevention technologies (MPTs) that combine pregnancy and HIV prevention into a single product could be highly beneficial. This qualitative study with health care providers in Kenya and South Africa examined health system factors that may facilitate or inhibit the delivery of these MPTs. Twelve qualitative interviews were conducted with health care providers at each site (24 interviews total). Providers were presented with pictures and actual placebo prototypes of 4 MPTs: a vaginal ring, an oral pill, an injectable, and an implant. Four themes emerged related to health care providers' reported interest in offering the proposed MPTs: (1) perceptions of young women's interest in the MPTs, (2) considerations about product administration, (3) feedback about product attributes, and (4) providers' training needs. Overwhelmingly, health care providers are eager to offer a product that prevents both HIV and unintended pregnancy in young women.