Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlled, cross-over studies in South Africa and Zimbabwe
Introduction
Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women’s sexual and reproductive health needs. We will gauge the DPP’s acceptability in two cross-over clinical trials.
Methods and analysis
PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16–40 years) and Harare, Zimbabwe (n=30, 16–24 years) will be randomised 1:1 to the order of regimens—DPP or two separate tablets—each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024.
Ethics and dissemination
PC952 was approved by the Ministry of Health and Child Care, Medical...
Source: BMJ Open - Category: General Medicine Authors: Friedland, B. A., Mgodi, N. M., Palanee-Phillips, T., Mathur, S., Plagianos, M. G., Bruce, I. V., Lansiaux, M., Murombedzi, C., Musara, P., Dandadzi, A., Reddy, K., Ndlovu, N., Zulu, S. K., Shale, L. R., Zieman, B., Haddad, L. B. Tags: Open access HIV/AIDS Source Type: research
More News: African Health | Children | Clinical Trials | Computers | Conferences | General Medicine | HIV AIDS | Hospitals | Medical Ethics | Pregnancy | Research | South Africa Health | Study | Viread | Women | Zimbabwe Health