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Correlates of Dapivirine Vaginal Ring Acceptance among Women Participating in an Open Label Extension Trial

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Abstract

MTN-025/HOPE was an open-label trial of the dapivirine vaginal ring conducted in four African countries between 2016 and 2018. Women were first offered one ring monthly (at baseline, months 1 and 2), thereafter, transitioned to a more applicable real-world dispensation schedule, − 3 rings quarterly (at months 3, 6 and 9). Logistic regression analysis was used to assess correlates of ring acceptance at baseline and through follow-up. A total of 1456 women (median age 31 years) enrolled, 1342 (92.2%) accepted the ring at baseline and 1163 (79.9%) accepted the ring(s) at all visits. Changing ring dispensation from a monthly to a quarterly schedule had no negative effect on acceptance. Having a primary partner and him knowing about the ring being offered in HOPE, use of long-acting contraception (implants, injections, IUDs) or sterilization were associated with ring acceptance, along with prior strong intention to use the ring in the future. Efforts should consider these factors when rolling out the ring for HIV prevention.

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Acknowledgments

The authors would like to acknowledge the full MTN-025/HOPE study team and HOPE study participants, without which this work would not have been possible. The vaginal rings used in this study were developed and supplied by the International Partnership for Microbicides (IPM). Data management was provided by the Statistical Center for HIV/AIDS Research & Prevention (Fred Hutchinson Cancer Research Center, Seattle, WA). Site laboratory oversight was provided by the Microbicide Trials Network Laboratory Center (Pittsburgh, PA). Study Team Leadership: Jared Baeten, University of Washington (Protocol Chair); Thesla Palanee-Phillips, Wits Reproductive Health and HIV Institute (Protocol Co-chair); Nyaradzo Mgodi, Zimbabwe, Harare, University of Zimbabwe College of Health Sciences Clinical Trials Unit(Protocol Co-chair) Elizabeth Brown, Fred Hutchinson Cancer Research Center (Protocol Statistician); Lydia Soto-Torres, US National Institute of Allergy and Infectious Diseases (Medical Officer); Ashley Mayo, FHI 360 (Clinical Research Manager). Study sites and site Investigators of Record: Malawi, Blantyre site (Johns Hopkins University, Queen Elizabeth Hospital): Bonus Makanani; Malawi, Lilongwe site (University of North Carolina, Chapel Hill): Lameck Chinula; South Africa, Cape Town site (University of Cape Town): Gonasagrie Nair; South Africa, Durban – Botha’s Hill, Chatsworth, Isipingo, Tongaat, Umkomaas, Verulam sites (South African Medical Research Council): Gita Ramjee, Logashvari Naidoo, Dishiki Kalonji, Samantha Siva, Nishanta Singh; South Africa, Durban, eThekwini site (Center for the AIDS Programme for Research in South Africa):Leila Mansoor; South Africa, Johannesburg site (Wits RHI): Thesla Palanee-Phillips; Uganda, Kampala site (John Hopkins University, Makerere University): Brenda Mirembe; Zimbabwe, Chitungwiza and Harare—Zengeza, Seke South and Splihaus sites (University of Zimbabwe Clinical Trials Research Centre (UZ-CTRC): Nyaradzo Mgodi, Portia Hunidzarira, and Felix Mhlanga.

Funding

The study was designed and implemented by the Microbicide Trials Network (MTN) and funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The vaginal rings used in this study were supplied by the International Partnership for Microbicides (IPM).

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Authors

Contributions

Jared M. Baeten, Elizabeth Brown, Ariane van der Straten, Lydia Soto-Torres, Thesla Palanee-Phillips, Nyaradzo Mgodi and Ashley Mayo contributed to the study conception, design, and study operations. Thesla Palanee-Phillips, Nyaradzo Mgodi, Rita Nakalega, Mandy Cobbing, Sufia Dadabhai, Leila E. Mansoor, Samantha Siva, Gonasagrie Nair, Lameck Chinula, Carolyne A. Akello, Clemensia Nakabiito and Brenda Gati Mirembe managed site operations, participant enrollment, follow-up, and data collection. Material preparation and data analysis for this manuscript were performed by Maria Valdez Cabrera and Elizabeth R. Brown. The first draft of the manuscript was written by Brenda G. Mirembe, Maria Valdez Cabrera, Ariane van der Straten, Ashley Mayo and Rita Nakalega and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Brenda Gati Mirembe.

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Conflicts of interest/Competing interests

The authors have no relevant financial or non-financial interests to disclose.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the following Institutional Review Boards/Ethics Committees and Drug Regulatory Authorities: Prevention Sciences Research Committee of the US National Institute of Allergy and Infectious Diseases; US Food and Drug Administration; National Health Sciences Research Committee of Malawi; Johns Hopkins University Bloomberg School of Public Health Institutional Review Board; University of North Carolina at Chapel Hill Institutional Review Board; Pharmacy, Medicines and Poisons Board of Malawi; University of Cape Town: Human Research Ethics Committee; Biomedical Research Ethics Committee University of KwaZulu-Natal; South African Medical Research Council Ethics Committee; Human Research Ethics Committee: (Medical), University of Witwatersrand, Johannesburg; Medicines Control Council of South Africa; Joint Clinical Research Centre Institutional Review Board; Uganda National Council for Science and Technology; Johns Hopkins University School of Medicine Institutional Review Board; National Drug Authority of Uganda; Medical Research Council of Zimbabwe; Committee on Human Research, University of California - San Francisco; Joint Parirenyatwa Hospital and College of Health Sciences Research Ethics; Research Council of Zimbabwe; Medicines Control Authority of Zimbabwe.

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Mirembe, B.G., Cabrera, M.V., van der Straten, A. et al. Correlates of Dapivirine Vaginal Ring Acceptance among Women Participating in an Open Label Extension Trial. AIDS Behav 27, 1030–1043 (2023). https://doi.org/10.1007/s10461-022-03841-z

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