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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

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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References

  1. UNAIDS D. Update AE. Geneva: Joint United Nations Programme on HIV. AIDS. 2019.

  2. Eakle R, Bourne A, Jarrett C, Stadler J, Larson H. Motivations and barriers to uptake and use of female-initiated, biomedical HIV prevention products in sub-Saharan Africa: an adapted meta-ethnography. BMC Public Health. 2017;17(1):968.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, et al. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. N Engl J Med. 2016;375(22):2121–32.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  4. Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015;372(6):509–18.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399–410.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  6. Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367(5):423–34.

    CAS  Article  PubMed  Google Scholar 

  7. Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, et al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013;381(9883):2083–90.

    Article  PubMed  Google Scholar 

  8. van der Straten A, Stadler J, Montgomery E, Hartmann M, Magazi B, Mathebula F, et al. Women’s experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa. PloS One. 2014;9(2):e89118.

    Article  PubMed  PubMed Central  Google Scholar 

  9. Baeten J, Palanee-Phillips T, Mgodi N, Ramjee G, Gati B, Mhlanga F, et al. High adherence and sustained impact on HIV-1 incidence: final results of an open-label extension trial of the dapivirine vaginal ring. J Int AIDS Soc. 2019;22:29.

    Google Scholar 

  10. Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, et al. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. N Engl J Med. 2016;375:2121.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  11. Nel A, Bekker L-G, Bukusi E, Hellstrӧm E, Kotze P, Louw C, et al. Safety, acceptability and adherence of dapivirine vaginal ring in a microbicide clinical trial conducted in multiple countries in Sub-Saharan Africa. PloS One. 2016;11(3):e0147743.

    Article  PubMed  PubMed Central  Google Scholar 

  12. World Health Organization. European Medicines Agency (EMA) approval of the dapivirine ring for HIV prevention for women in high HIV burden settings. Geneva: WHO; 2020.

    Google Scholar 

  13. Underhill K, Morrow KM, Colleran C, Calabrese SK, Operario D, Salovey P, et al. Explaining the efficacy of pre-exposure prophylaxis (PrEP) for HIV prevention: a qualitative study of message framing and messaging preferences among US men who have sex with men. AIDS Behav. 2016;20(7):1514–26.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Koblin BA, Mansergh G, Frye V, Tieu HV, Hoover DR, Bonner S, et al. Condom-use decision making in the context of hypothetical pre-exposure prophylaxis efficacy among substance-using men who have sex with men: project MIX. JAIDS J Acquir Immun Defic Syndr. 2011;58(3):319–27.

    Article  Google Scholar 

  15. Montgomery ET, Stadler J, Naidoo S, Katz AW, Laborde N, Garcia M, et al. Reasons for nonadherence to the dapivirine vaginal ring: narrative explanations of objective drug-level results. AIDS. 2018;32(11):1517–25.

    CAS  Article  PubMed  Google Scholar 

  16. Woodsong C, Alleman P, Musara P, Chandipwisa A, Chirenje M, Martinson F, et al. Preventive misconception as a motivation for participation and adherence in microbicide trials: evidence from female participants and male partners in Malawi and Zimbabwe. AIDS Behav. 2012;16(3):785–90.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Katz AW, Naidoo K, Reddy K, Chitukuta M, Nabukeera J, Siva S, et al. The power of the shared experience: MTN-020/ASPIRE trial participants’ descriptions of peer influence on acceptability of and adherence to the dapivirine vaginal ring for HIV prevention. AIDS Behav. 2020;24:2387.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Montgomery ET, van der Straten A, Chidanyika A, Chipato T, Jaffar S, Padian N. The importance of male partner involvement for women’s acceptability and adherence to female-initiated HIV prevention methods in Zimbabwe. AIDS Behav. 2011;15(5):959–69.

    Article  PubMed  Google Scholar 

  19. Montgomery ET, van der Straten A, Stadler J, Hartmann M, Magazi B, Mathebula F, et al. Male partner influence on women’s HIV prevention trial participation and use of pre-exposure prophylaxis: the importance of “understanding.” AIDS Behav. 2015;19(5):784–93.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Chitukuta M, Duby Z, Katz A, Nakyanzi T, Reddy K, Palanee-Phillips T, et al. Negative rumours about a vaginal ring for HIV-1 prevention in sub-Saharan Africa. Cult Health Sex. 2019;21(11):1209–24.

    Article  PubMed  PubMed Central  Google Scholar 

  21. Dellar RC, Karim QA, Mansoor LE, Grobler A, Humphries H, Werner L, et al. The preventive misconception: experiences from CAPRISA 004. AIDS Behav. 2014;18(9):1746–52.

    Article  PubMed  Google Scholar 

  22. Ott MA, Alexander AB, Lally M, Steever JB, Zimet GD, the Adolescent Medicine Trials Network (ATN). Preventive misconception and adolescents’ knowledge about HIV vaccine trials. J Med Ethics. 2013;39(12):765–71.

    Article  PubMed  Google Scholar 

  23. Lally M, Goldsworthy R, Sarr M, Kahn J, Brown L, Peralta L, et al. Evaluation of an intervention among adolescents to reduce preventive misconception in HIV vaccine clinical trials. J Adolesc Health. 2014;55(2):254–9.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Stadler J, Saethre E. Blockage and flow: intimate experiences of condoms and microbicides in a South African clinical trial. Cult Health Sex. 2011;13(1):31–44.

    Article  PubMed  Google Scholar 

  25. Young I, Valiotis G. Strategies to support HIV literacy in the roll-out of pre-exposure prophylaxis in Scotland: findings from qualitative research with clinical and community practitioners. BMJ Open. 2020;10(4):e033849.

    Article  PubMed  PubMed Central  Google Scholar 

  26. van der Straten A, Montgomery ET, Musara P, Etima J, Naidoo S, Laborde N, et al. Disclosure of pharmacokinetic drug results to understand nonadherence: results from a qualitative study. AIDS (London, England). 2015;29(16):2161.

    Article  Google Scholar 

  27. Rubincam C, Newman PA, Atujuna M, Bekker L-G. ‘Why would you promote something that is less percent safer than a condom?’: Perspectives on partially effective HIV prevention technologies among key populations in South Africa. SAHARA-J J Soc Asp HIV/AIDS. 2018;15(1):179.

    Article  Google Scholar 

  28. Tarkang EE, Zotor FB. Application of the Health Belief Model (HBM) in HIV prevention: a literature review. Central Afr J Public Health. 2015;1(1):1–8.

    Google Scholar 

  29. Marshall VK, Given BA. Factors associated with medication beliefs in patients with cancer: an integrative review. Oncol Nurs Forum. 2018;45:508.

    Article  PubMed  Google Scholar 

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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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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.

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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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Keywords

  • Efficacy
  • Understanding
  • Perceptions
  • Dapivirine vaginal ring