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.

Autor:	Friedland BA; Population Council, Center for Biomedical Research, New York, New York, USA Bfriedland@popcouncil.org., Mgodi NM; University of Zimbabwe - Clinical Trials Research Centre, Harare, Zimbabwe., Palanee-Phillips T; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Faculty of Health Sciences, School of Public Health, Johannesburg, South Africa.; University of Washington, Department of Epidemiology, School of Public Health, Seattle, Washington, USA., Mathur S; Population Council, Washington, District of Columbia, USA., Plagianos MG; Population Council, Center for Biomedical Research, New York, New York, USA., Bruce IV; Population Council, Center for Biomedical Research, New York, New York, USA., Lansiaux M; Population Council, Center for Biomedical Research, New York, New York, USA., Murombedzi C; University of Zimbabwe - Clinical Trials Research Centre, Harare, Zimbabwe., Musara P; University of Zimbabwe - Clinical Trials Research Centre, Harare, Zimbabwe., Dandadzi A; University of Zimbabwe - Clinical Trials Research Centre, Harare, Zimbabwe., Reddy K; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Faculty of Health Sciences, School of Public Health, Johannesburg, South Africa., Ndlovu N; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Faculty of Health Sciences, School of Public Health, Johannesburg, South Africa., Zulu SK; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Faculty of Health Sciences, School of Public Health, Johannesburg, South Africa., Shale LR; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Faculty of Health Sciences, School of Public Health, Johannesburg, South Africa., Zieman B; Population Council, Center for Biomedical Research, New York, New York, USA., Haddad LB; Population Council, Center for Biomedical Research, New York, New York, USA.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Mar 12; Vol. 14 (3), pp. e075381. Date of Electronic Publication: 2024 Mar 12.
DOI:	10.1136/bmjopen-2023-075381
Abstrakt:	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 Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand's Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences. Trial Registration Numbers: NCT04778514, NCT04778527. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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