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Correlates of Adherence to the Dapivirine Vaginal Ring for HIV-1 Prevention

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Abstract

Understanding characteristics associated with adherence to pre-exposure prophylaxis (PrEP) methods for HIV-1 prevention may assist with optimizing implementation efforts. The dapivirine vaginal ring is a novel topical PrEP delivery method. Using data from a randomized, double-blind, placebo-controlled, phase III trial of the dapivirine vaginal ring conducted in four African countries, generalized estimating equation models were used to evaluate correlates of ring adherence. Two levels of quarterly dapivirine blood plasma, and dapivirine released from returned rings defined measures of adherence for recent and cumulative use, respectively. Time on study, calendar time, primary partner knowledge that the participant was taking part in the study, and use of long-acting contraceptive methods were associated with ring adherence whereas younger age, ring worries, condom use, episodes of menstrual bleeding and vaginal washing were associated with non-adherence. These findings may be useful for recruitment into future clinical studies and dapivirine ring implementation efforts.

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Acknowledgements

We wish to thank the MTN-020/ASPIRE study team, including those who made the dapivirine laboratory testing possible, as well as the dedication of all study participants. MTN-020/ASPIRE Study Team: Study Team Leadership: Jared Baeten, University of Washington (Protocol Chair); Thesla Palanee-Phillips, Wits Reproductive Health and HIV Institute (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); Katie Schwartz, 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): Francis Martinson. South Africa, Cape Town site (University of Cape Town): Linda-Gail Bekker; South Africa, Durban – Botha’s Hill, Chatsworth, Isipingo, Tongaat, Umkomaas, Verulam sites (South African Medical Research Council): Vaneshree Govender, Samantha Siva, Zakir Gaffoor, Logashvari Naidoo, Arendevi Pather, and Nitesha Jeenarain; South Africa, Durban, eThekwini site (Center for the AIDS Programme for Research in South Africa): Gonasagrie Nair; South Africa, Johannesburg site (Wits RHI): Thesla Palanee-Phillips; Uganda, Kampala site (John Hopkins University, Makerere University): Flavia Matovu; Zimbabwe, Chitungwiza, Seke South and Zengeza sites (University of Zimbabwe, University of California San Francisco): Nyaradzo Mgodi; Zimbabwe, Harare, Spilhaus site (University of Zimbabwe, University of California San Francisco): Felix Mhlanga. Data management was provided by The Statistical Center for HIV/AIDS Research & Prevention (Fred Hutchinson Cancer Research Center, Seattle, WA) and site laboratory oversight was provided by the Microbicide Trials Network Laboratory Center (Pittsburgh, PA).

Funding

The MTN-020/ASPIRE study was designed and implemented by the Microbicide Trials Network (MTN). The MTN is 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. 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 developed and supplied by the International Partnership for Microbicides (IPM).

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Authors and Affiliations

  1. Fred Hutchinson Cancer Research Center, Seattle, USA

    Marla J. Husnik & Elizabeth R. Brown

  2. University of Washington, Seattle, USA

    Marla J. Husnik & Jared M. Baeten

  3. Wits Reproductive Health and HIV Institute, University of the Witwatersrand, School of Clinical Medicine, Johannesburg, South Africa

    Thesla Palanee-Phillips

  4. National Institutes of Health, Bethesda, USA

    Lydia Soto-Torres

  5. Magee-Womens Research Institute, Pittsburgh, USA

    Edward Livant & Devika Singh

  6. MU-JHU Research Collaboration, Kampala, Uganda

    Flavia Matovu Kiweewa & Brenda Gati Mirembe

  7. Centre for the AIDS Programme of Research in South Africa, Durban, South Africa

    Leila E. Mansoor

  8. South African Medical Research Council, Durban, South Africa

    Zakir Gaffoor, Nitesha Jeenarain & Samantha Siva

  9. Johns Hopkins Bloomberg School of Public Health, Blantyre, Malawi

    Sufia S. Dadabhai

  10. RTI International, Women’s Global Health Imperative, San Francisco, CA, USA

    Ariane van der Straten

  11. Center for AIDS Prevention Studies, Department of Medicine, UCSF, San Francisco, CA, USA

    Ariane van der Straten

  12. Department of Global Health, University of Washington, 325 Ninth Avenue, Box 359927, Seattle, WA, 98104, USA

    Jared M. Baeten

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  1. Marla J. Husnik
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Consortia

for the M. T. N.-020/ASPIRE Study Team

  • Jared Baeten
  • , Thesla Palanee-Phillips
  • , Elizabeth Brown
  • , Lydia Soto-Torres
  • , Katie Schwartz
  • , Bonus Makanani
  • , Francis Martinson
  • , Linda-Gail Bekker
  • , Vaneshree Govender
  • , Samantha Siva
  • , Zakir Gaffoor
  • , Logashvari Naidoo
  • , Arendevi Pather
  • , Nitesha Jeenarain
  •  & Felix Mhlanga

Corresponding author

Correspondence to Jared M. Baeten.

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Conflict of interest

Financial interests—Dr. Jared M. Baeten has received research grants from NIH, CDC, USAID, and Bill & Melinda Gates Foundation. Non-financial interests—Dr. Jared M. Baeten has served on advisory boards for Gilead Sciences, Janssen, and Merck corporations.

Ethical Approval

Institutional review boards at each participating clinical site approved the study protocol. In obtaining and documenting informed consent, the investigator of record and their designees complied with applicable local and US regulatory requirements and adhered to Good Clinical Practices and ethical principles that have their origin in the Declaration of Helsinki.

Informed Consent

All participants provided written informed consent for participation and specimen storage.

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Husnik, M.J., Brown, E.R., Dadabhai, S.S. et al. Correlates of Adherence to the Dapivirine Vaginal Ring for HIV-1 Prevention. AIDS Behav 25, 2801–2814 (2021). https://doi.org/10.1007/s10461-021-03231-x

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