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Acceptability and Use of the Dapivirine Vaginal Ring and Daily Oral Pre-exposure Prophylaxis (PrEP) During Breastfeeding in South Africa, Malawi, Zimbabwe, and Uganda

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Abstract

This study examines qualitative acceptability of the dapivirine vaginal ring (DVR) and oral daily pre-exposure prophylaxis (PrEP) among breastfeeding persons participating in Microbicide Trials Network 043/B-PROTECTED, a phase 3B safety and drug detectability study of DVR and oral PrEP in breastfeeding. A subsample of 52 participants were purposively sampled to participate in an in-depth interview (IDI). Breastfeeding participants found both study products to be acceptable, and easy to use. A common motivation for product use was to protect the baby from HIV, although participants’ understanding of how the study drug would work to protect their babies was often unclear. While most participants did not report experiencing side effects, fears about side effects were common as both initial worries about how the study products would affect their health and the health of their baby, and increased anxiety that health issues experienced by them, or their baby were from the products.

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Data Availability

Data are available through the Microbicide Trials Network.

Code Availability

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Acknowledgements

Full MTN-043/B-PROTECTED Study Team: Study Site Staff: Frank Taulo, MBBS, MPH, FCOG (Investigator of Record [IoR]), Linly Seyama, MSc, RNM (Study Coordinator [SC]), Zayithwa Fabiano, MBBS (SC), Sufia Dadabhai, PhD (Clinical Research Site [CRS] Leader), and Taha Taha, PhD (Clinical Trials Unit [CTU] Principal Investigator [PI], Johns Hopkins University Research Project; Brenda Gati Mirembe, MBChB, MSc (IoR), Phionah Bridget Kibalama Ssemambo, MBchB, MSc PH (SC), Clemensia Nakabiito, MBChB, MMed (Co-Investigator), and Mary Glenn Fowler, MD, MPH (CTU PI), Makerere University—Johns Hopkins University (MU-JHU) Research Collaboration; Elizea Horne, MBChB (IoR), Carlotta Mabuza, BS, PGDip, Dip (SC), Lee Fairlie, MBChB, FCPaeds (CRS Leader), and Hermien Gous, PharmD (CRS Leader), Wits RHI Shandukani Research Centre; Felix Mhlanga, MBChB, MMed (IoR), Nyaradzo M. Mgodi, MBChB, Mmed (IoR), Petina Musara, BSW (SC), and Z. Mike Chirenje, MD, FRCOG (CTU PI), University of Zimbabwe Clinical Trials Research Centre (UZ-CTRC)

Protocol Team: Jeanna M. Piper, MD (DAIDS Senior Medical Officer (MO)), Naana Cleland, PhD (Health Specialist Clinical Microbicide Research Branch (CMRB)), and Roberta Black, PhD (Chief, CMRB), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS); Nahida Chakhtoura, MD, MsGH (NICHD MO), Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institutes of Health (NIH); Dianne M. Rausch, PhD (Director, DAIDS Research) and Teri Senn, PhD (Program Chief, Psychosocial Comorbidities of HIV Prevention and Treatment), National Institutes of Mental Health (NIMH); James F. Rooney, MD (Vice President Medical Affairs), Gilead Sciences; Zeda Rosenberg, ScD (Chief Executive Officer), International Partnership for Microbicides; Craig Hendrix, MD (Biomedical Science Working Group (BSWG) Representative, Protocol Pharmacologist), Jenny Robinson, MD, MPH, FACOG (BSWG Representative), Bonus Makanani MB BS, FCOG (SA), Department of Obstetrics & Gynecology, College of Medicine, University of Malawi, and College of Medicine-Johns Hopkins Research Project in Blantyre, Lisa Noguchi, PhD, CNM (Protocol Co-Chair), and Mark Marzinke, PhD, DABCC (Laboratory Center [LC] Pharmacology Core), Johns Hopkins University; Peter Anderson, PharmD (LC Pharmacology Core), University of Colorado School of Pharmacy; Rachel Scheckter, MPH (Sr. Clinical Research Manager [CRM]), Ashley J. Mayo, MPH (Sr. CRM), Tara McClure, MPH (Sr. CRM), Abraham Johnson, MPH (Community Program Associate), Cheryl Blanchette, MS(Sr. Community Program (MTN). Manager (CPM), Jontraye Davis, MHA (CPM), and Lisa Levy, MPH, MTN Associate Director, FHI 360; Katherine Bunge, MD, MPH (Protocol Safety Physician [PSP]), Richard H. Beigi, MD, MSc (Protocol Physician), and Sharon A. Riddler, MD, MPH (Protocol Physician), Magee-Womens Hospital and the University of Pittsburgh Medical Center (UPMC); Devika Singh, MD, MPH (PSP), University of Vermont; Cindy Jacobson, PharmD (Director of Pharmacy Affairs), Edward Livant, BSMT (ASCP), MPH (MTN LC Research Manager), May Beamer, BS (Laboratory Manager), Lisa Rossi, BA (MTN Director of Communications), Luis Duran, DrPH, MPIA (Project Manager), Mei Song, PhD (Project Manager), and Sharon Hillier, PhD (MTN Principal Investigator), Magee-Womens Research Institute-UPMC; Elizabeth Montgomery, PhD (Behavioral Research Working Group [BRWG] Lead), Imogen Hawley, MA, MSc (Qualitative Coordinator), and Marie Stoner, PhD (Qualitative Coordinator), RTI International; Ivan Balan, PhD (BRWG Representative), Florida State University College of Medicine; Maxensia Owor, MBChB, MMed (Paed), MPH (Protocol Chair), MU-JHU; Barbra Richardson, PhD (Statistician), Jennifer Balkus, PhD, MPH (Protocol Co-Chair), Holly Gundacker, MS (Statistical Research Associate), Jillian Zemanek, MPH (Lead Clinical Data Manager), and Wen-Min Hou, MPH, BSN (Lead Clinical Safety Associate), Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center and the University of Washington.

Data Management: Data management was provided by The Statistical Center for HIV/AIDS Research & Prevention (Fred Hutchinson Cancer Center, Seattle, WA) and site laboratory oversight was provided by the Microbicide Trials Network Laboratory Center (Pittsburgh, PA). For qualitative data, management was provided by the Women’s Global Health Imperative Program (RTI International, Berkeley, CA). We would also like to acknowledge Maryam Matean and Alejandro Baez at RTI international for their support with qualitative coding and analysis.

Funding

The study was designed and implemented by the Microbicide Trials Network (MTN). From 2006 until November 30, 2021, the MTN was an HIV/AIDS clinical trial network 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 NIH.

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Authors and Affiliations

  1. Women’s Global Health Imperative, RTI International, 2150 Shattuck Avenue, Berkeley, CA, 94104, USA

    Marie C. D. Stoner, Imogen Hawley & Elizabeth T. Montgomery

  2. Makerere University–Johns Hopkins University (MU-JHU) Research Collaboration, Kampala, Uganda

    Juliane Etima, Doreen Kemigisha & Maxensia Owor

  3. Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe

    Prisca Mutero & Adlight Dandadzi

  4. FHI 360, Durham, USA

    Rachel Scheckter

  5. Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

    Florence Mathebula & Elizea Horne

  6. Department of Epidemiology, University of Washington School of Public Health, Seattle, USA

    Jennifer E. Balkus

  7. Vaccine and Infectious Disease Division, Fred Hutch Cancer Center, Seattle, USA

    Jennifer E. Balkus

  8. Division of Reproductive, Maternal, Newborn, Child and Adolescent Health, Jhpiego/Johns Hopkins University, Washington, DC, USA

    Lisa Noguchi

  9. Johns Hopkins Project, College of Medicine, University of Malawi, Blantyre, Malawi

    Linly Seyama & Zayithwa Fabiano

Authors
  1. Marie C. D. Stoner
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  2. Imogen Hawley
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  3. Florence Mathebula
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  15. Elizabeth T. Montgomery
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Contributions

MCDS, IH and ETM managed qualitative data and did coding and data analysis. FM, EH, JE, DK, PM, AD, LS, and ZF conducted data collection, and quality control of transcripts. RS, LM, MO and JEB over saw study implementation. MCDS led manuscript writing with support from IH and ETM. All authors have read and approved the final manuscript.

Corresponding author

Correspondence to Marie C. D. Stoner.

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Conflict of interest

The authors have not disclosed any competing interests.

Ethical 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; College of Medicine Research and Ethics Committee; Johns Hopkins School of Public Health Institutional Review Board; Pharmacy, Medicines and Poisons Board of Malawi; Human Research Ethics Committee: (Medical), University of Witwatersrand, Johannesburg; South African Health Products Regulatory Authority; Joint Clinical Research Centre Institutional Review Board; Uganda National Council for Science and Technology; Johns Hopkins Medicine Office of Human Subjects Research Institutional Review Board; National Drug Authority of Uganda; Medical Research Council of Zimbabwe; Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals; Research Council of Zimbabwe; Medicines Control Authority of Zimbabwe.

Consent to Participate

All participants provided informed consent for the study.

Study Products

The DVRs used in this study were developed and supplied by the International Partnership for Microbicides (IPM). Oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) was donated by Gilead Sciences.

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Stoner, M.C.D., Hawley, I., Mathebula, F. et al. Acceptability and Use of the Dapivirine Vaginal Ring and Daily Oral Pre-exposure Prophylaxis (PrEP) During Breastfeeding in South Africa, Malawi, Zimbabwe, and Uganda. AIDS Behav 27, 4114–4123 (2023). https://doi.org/10.1007/s10461-023-04125-w

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