Women's experience receiving drug feedback and adherence counseling in MTN-025/HOPE - an HIV Prevention open-label trial of the Dapivirine Vaginal Ring

Ariana Wendy Keel Katz; Iván C Balán; Krishnaveni Reddy; Juliane Etima; Kubashni Weber; Thelma Tauya; Millicent Atujuna; Rachel Scheckter; Kenneth Ngure; Lydia Soto-Torres; Nyaradzo Mgodi; Thesla Palanee-Phillips; Jared M Baeten; Ariane van der Straten

doi:10.1007/s10461-022-03663-z

Women's experience receiving drug feedback and adherence counseling in MTN-025/HOPE - an HIV Prevention open-label trial of the Dapivirine Vaginal Ring

AIDS Behav. 2022 Nov;26(11):3607-3619. doi: 10.1007/s10461-022-03663-z. Epub 2022 May 10.

Authors

Ariana Wendy Keel Katz¹, Iván C Balán^{2

3}, Krishnaveni Reddy⁴, Juliane Etima⁵, Kubashni Weber⁶, Thelma Tauya⁷, Millicent Atujuna⁸, Rachel Scheckter⁹, Kenneth Ngure¹⁰, Lydia Soto-Torres¹¹, Nyaradzo Mgodi⁷, Thesla Palanee-Phillips⁴, Jared M Baeten^{12

13}, Ariane van der Straten^{14

15}

Affiliations

¹ RTI International, 2150 Shattuck Avenue, Suite 800, 94104, Berkeley, CA, USA. [email protected].
² HIV Center for Clinical and Behavioral Studies, Columbia University, New York, New York, United States.
³ Present affiliation Florida State University College of Medicine, Tallahassee, FL, USA.
⁴ Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa.
⁵ Makerere University, Johns Hopkins University Research Collaboration, Kampala, Uganda.
⁶ Medical Research Council, Durban, South Africa.
⁷ College of Health Sciences Clinical Trials Unit, University of Zimbabwe, Harare, Zimbabwe.
⁸ Desmond Tutu AIDS Foundation, University of Cape Town, Cape Town, South Africa.
⁹ FHI 360, Durham, North Carolina, USA.
¹⁰ Department of Community Health, Jomo Kenyatta University of Agriculture and Technology, Juja, Kenya.
¹¹ DAIDS, NIH/NIAID, Bethesda, MD, USA.
¹² University of Washington, Seattle, WA, USA.
¹³ Present affiliation Gilead Sciences, Foster City, CA, USA.
¹⁴ Center for AIDS Prevention Studies (CAPS), University of California San Francisco, San Francisco, CA, USA.
¹⁵ Present affiliation ASTRA Consulting, Kensington, CA, USA.

Abstract

In the Phase IIIB MTN-025/HOPE open label extension trial, participants were offered the dapivirine vaginal ring as HIV prophylaxis, and those who accepted the ring received semi real-time individual adherence feedback, based on residual drug level (RDL) from returned rings, during Motivational Interviewing-based counseling. Counseling messages, based on the best knowledge at the time, framed RDL results in terms of ring use and HIV protection, from no use /no protection (0 RDL) to high use /high protection (3 RDL). At six HOPE sites, in-depth-Interviews (IDIs) about RDL were conducted with 64 participants who had received at least one RDL result. We found mixed interpretations of what the RDL meant and strong emotional reactions with a focus on the external validation of the level itself. Counseling was critical to help participants process their reactions to the RDL and make decisions accordingly (i.e., persistence, adherence improvement, and/or switching to another HIV prevention method). Providing drug adherence feedback was complex to implement yet proved useful as a component of a multi-pronged adherence support strategy.

Keywords: Dapivirine vaginal ring; Drug feedback; HIV prevention; Microbicide.

Publication types

Clinical Trial, Phase III

MeSH terms

Anti-HIV Agents* / therapeutic use
Contraceptive Devices, Female*
Counseling
Feedback
Female
HIV Infections* / drug therapy
HIV Infections* / prevention & control
Humans
Pyrimidines
Research Design

Substances

Anti-HIV Agents
Pyrimidines
Dapivirine

Abstract

Publication types

MeSH terms

Substances

Grants and funding