FEM-PrEP

Facilitators of Adherence to the Study Pill in the FEM-PrEP Clinical Trial

INTRODUCTION FEM-PrEP did not demonstrate a reduction in HIV acquisition because of low study pill adherence. Yet, plasma and intracellular drug concentrations indicated that some participants had evidence of recent pill use. We conducted a follow-up study to identify, among other topics, participants' reasons for taking the study pill. METHODS Qualitative, semi-structured interviews (SSIs) w...

Hepatitis B virus reactivation or reinfection in a FEM-PrEP participant: a case report

INTRODUCTION The FEM-PrEP trial was a pre-exposure prophylaxis clinical trial to test the safety and efficacy of Truvada (tenofovir disoproxil fumarate and emtricitabine) in the prevention of human immunodeficiency virus infection. Because Truvada can suppress hepatitis B virus replication, and withdrawal of Truvada can cause hepatic flares in patients with chronic hepatitis B, pre-enrollment s...

Medroxyprogesterone acetate levels among Kenyan women using depot medroxyprogesterone acetate in the FEM-PrEP trial☆☆☆

OBJECTIVE To describe medroxyprogesterone acetate (MPA) levels among Kenyan depot medroxyprogesterone acetate (DMPA) users in the FEM-PrEP HIV prevention trial, and to compare MPA levels between ARV for HIV prevention (treatment) and placebo groups. STUDY DESIGN We measured MPA in previously collected plasma samples from 63 Kenyan trial participants who used DMPA for one or two complete inter...

To prep or not to prep.

The Sexual Risk Context among the FEM-PrEP Study Population in Bondo, Kenya and Pretoria, South Africa

BACKGROUND Incidence rates in the FEM-PrEP and VOICE trials demonstrate that women from diverse sub-Saharan African communities continue to be at substantial HIV risk. OBJECTIVE To describe and compare the sexual risk context of the study population from two FEM-PrEP trial sites-Bondo, Kenya, and Pretoria, South Africa. METHODS At baseline we collected information about demographics, sexual...