{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T14:25:15Z","timestamp":1768314315276,"version":"3.49.0"},"reference-count":56,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,3,13]],"date-time":"2024-03-13T00:00:00Z","timestamp":1710288000000},"content-version":"unspecified","delay-in-days":12,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010409","name":"The Children\u2019s Investment Fund Foundation","doi-asserted-by":"crossref","award":["2106-06589"],"award-info":[{"award-number":["2106-06589"]}],"id":[{"id":"10.13039\/100010409","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100010409","name":"The Children\u2019s Investment Fund Foundation","doi-asserted-by":"crossref","award":["1903-03681"],"award-info":[{"award-number":["1903-03681"]}],"id":[{"id":"10.13039\/100010409","id-type":"DOI","asserted-by":"crossref"}]},{"name":"National Institute of Mental Health of the National Institutes of Health","award":["R34MH119982"],"award-info":[{"award-number":["R34MH119982"]}]},{"name":"U.S. President\u2019s Emergency Plan for AIDS Relief (PEPFAR) and U.S. Agency for International Development","award":["AID-OAA-A-13-00088"],"award-info":[{"award-number":["AID-OAA-A-13-00088"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,2,7]]},"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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\u2019s sexual and reproductive health needs. We will gauge the DPP\u2019s acceptability in two cross-over clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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\u201340\u2009years) and Harare, Zimbabwe (n=30, 16\u201324\u2009years) will be randomised 1:1 to the order of regimens\u2014DPP or two separate tablets\u2014each 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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\u2019s 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration numbers<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04778514\">NCT04778514<\/jats:ext-link>\n                      ,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04778527\">NCT04778527<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-075381","type":"journal-article","created":{"date-parts":[[2024,3,13]],"date-time":"2024-03-13T01:50:26Z","timestamp":1710294626000},"page":"e075381","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["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"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct04778514","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04778527","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04778527","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04778514","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5041-3634","authenticated-orcid":false,"given":"Barbara A","family":"Friedland","sequence":"first","affiliation":[{"name":"Population Council, Center for Biomedical Research, New York, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nyaradzo M","family":"Mgodi","sequence":"additional","affiliation":[{"name":"University of Zimbabwe - Clinical Trials Research Centre, Harare, Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thesla","family":"Palanee-Phillips","sequence":"additional","affiliation":[{"name":"Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Faculty of Health Sciences, School of Public Health, Johannesburg, South Africa"},{"name":"University of Washington, Department of Epidemiology, School of Public Health, Seattle, Washington, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanyukta","family":"Mathur","sequence":"additional","affiliation":[{"name":"Population Council, Washington, District of Columbia, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marlena G","family":"Plagianos","sequence":"additional","affiliation":[{"name":"Population Council, Center for Biomedical Research, New York, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irene V","family":"Bruce","sequence":"additional","affiliation":[{"name":"Population Council, Center for Biomedical Research, New York, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maud","family":"Lansiaux","sequence":"additional","affiliation":[{"name":"Population Council, Center for Biomedical Research, New York, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline","family":"Murombedzi","sequence":"additional","affiliation":[{"name":"University of Zimbabwe - Clinical Trials Research Centre, Harare, Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Petina","family":"Musara","sequence":"additional","affiliation":[{"name":"University of Zimbabwe - Clinical Trials Research Centre, Harare, Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adlight","family":"Dandadzi","sequence":"additional","affiliation":[{"name":"University of Zimbabwe - Clinical Trials Research Centre, Harare, Zimbabwe"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Krishnaveni","family":"Reddy","sequence":"additional","affiliation":[{"name":"Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Faculty of Health Sciences, School of Public Health, Johannesburg, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nkosiphile","family":"Ndlovu","sequence":"additional","affiliation":[{"name":"Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Faculty of Health Sciences, School of Public Health, Johannesburg, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sihle K","family":"Zulu","sequence":"additional","affiliation":[{"name":"Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Faculty of Health Sciences, School of Public Health, Johannesburg, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lerato R","family":"Shale","sequence":"additional","affiliation":[{"name":"Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Faculty of Health Sciences, School of Public Health, Johannesburg, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brady","family":"Zieman","sequence":"additional","affiliation":[{"name":"Population Council, Center for Biomedical Research, New York, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa B","family":"Haddad","sequence":"additional","affiliation":[{"name":"Population Council, Center for Biomedical Research, New York, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,3,12]]},"reference":[{"key":"2025120617565660000_14.3.e075381.1","unstructured":"Joint United Nations Programme on HIV\/AIDS . 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