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Does the Ring Work? Perceptions and Understanding of the Efficacy of a Dapivirine Vaginal Ring for HIV Prevention Amongst Women in a Placebo-Controlled Trial

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Abstract

As demonstrated by the Phase III clinical trial, MTN-020/ASPIRE, the monthly dapivirine vaginal ring is well tolerated and reduces the risk of HIV-1 as a woman-initiated prevention option. This analysis uses data from the follow-on MTN-032/Assessment of ASPIRE and HOPE Adherence (AHA) qualitative study to understand how perceptions (or misperceptions) of ring efficacy may have influenced behavior during ASPIRE, and affected intention to use the ring in future ring projects, specifically HOPE, the planned open-label extension study. Single in-depth interviews (n = 98) and 12 focus group discussions (n = 89) were conducted with women at seven sites in Malawi, South Africa, Uganda and Zimbabwe. Eligibility included participation in the ASPIRE active arm, and ring use for ≥ 3 months or at least 1 month if seroconversion occurred. Interviews were audio-recorded, transcribed into English, coded in Dedoose and thematically analyzed. Demographic and behavioral questionnaire data were summarized in Stata. Most AHA participants perceived the ring to be effective, and described simply trusting it or having confidence in it because they, or other participants in risky situations, remained HIV-uninfected. Participants described ring efficacy after receiving ASPIRE results as a binary assessment: the ring worked or not. Many did not remember exact efficacy percentages because of lack of comprehension or memory but recalled key details about age differences. The majority expressed interest in future ring use. There is a need to investigate improved ways of explaining placebo-controlled trials and efficacy to women in Sub-Saharan Africa. Now that ring efficacy, is known, these benefits must be well communicated, and understood by end-users and key stakeholders. Engagement with end-users to construct effective messages and to develop tools to measure understanding of partial efficacy will be essential.

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Funding

The MTN-032 study was designed and implemented by the Microbicide Trials Network (MTN) funded by the National Institute of Allergy and Infectious Diseases through individual grants (UM1AI068633, UM1AI068615 and 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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Author notes

  1. Morgan Garcia

    Present address: FHI360, Durham, USA

Authors and Affiliations

  1. Makerere University-Johns Hopkins University Research Collaboration, Upper Mulago Hill Road, P. O. Box 23491, Kampala, Uganda

    Juliane Etima

  2. Women’s Global Health Imperative, RTI International, Berkeley, CA, USA

    Ariana W. K. Katz & Elizabeth T. Montgomery

  3. Division of Social and Behavioural Sciences in the School of Public Health and Family Medicine, University of Cape Town, Rondebosch, Cape Town, South Africa

    Zoe Duby

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

    Thesla Palanee-Phillips, Krishnaveni Reddy & Florence Mathebula

  5. UNC-Lilongwe, Lilongwe, Malawi

    Chifundo Zimba

  6. Centre for the AIDS Programme of Research in South African (CAPRISA), Durban, South Africa

    Leila E. Mansoor

  7. Magee-Womens Research Institute, Pittsburgh, PA, USA

    Devika Singh

  8. University of Zimbabwe College of Health Sciences Clinical Trials Research Centre (UZCHS-CTRC), Harare, Zimbabwe

    Elmah Manengamambo

  9. HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa

    Sarita Naidoo

  10. The Aurum Institute, Johannesburg, South Africa

    Sarita Naidoo

  11. Division of AIDS, NIH, Bethesda, MD, USA

    Lydia Soto-Torres

Authors
  1. Juliane Etima
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  2. Ariana W. K. Katz
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Consortia

the MTN-020/ASPIRE, MTN 025/HOPE, MTN-032 Study teams

Contributions

All authors contributed to the review and finalization of this paper. The original draft preparation was done by Juliane Etima under the mentorship of Zoe Duby. Detailed content review was done by Elizabeth Montgomery who was the study Protocol Chair, Ariana Katz of Research Triangle Institute (RTI) International and Morgan Garcia of Family Health International (FHI) 360. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Juliane Etima.

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Conflict of interest

The primary author implemented the study at the Kampala-Uganda site as the Investigator of Record through the Microbicide Trials Network (MTN). The study was funded by the National Institute of Allergy and Infectious Diseases through individual grants (UM1AI068633, UM1AI068615 and 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 primary author received salary support during the implementation of this study.

Ethical Approval

This study was approved at the various study sites by all regulatory/ethics committees in each respective country. At Makerere University-Johns Hopkins University (MUJHU) in Uganda where the primary author conducted the study, ethical approval was received from Joint Clinical Research (JCRC) ethics review committee, Uganda National Council for Science and Technology (UNCST) and Johns Hopkins Medicine IRB. All study participants were consented for participation in the study, dissemination and publication of the study findings.

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Etima, J., Katz, A.W.K., Duby, Z. et al. Does the Ring Work? Perceptions and Understanding of the Efficacy of a Dapivirine Vaginal Ring for HIV Prevention Amongst Women in a Placebo-Controlled Trial. AIDS Behav 26, 1597–1606 (2022). https://doi.org/10.1007/s10461-021-03512-5

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