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 KatzIván C BalánKrishnaveni ReddyJuliane EtimaKubashni WeberThelma TauyaMillicent AtujunaRachel ScheckterKenneth NgureLydia Soto-TorresNyaradzo MgodiThesla Palanee-PhillipsJared M BaetenAriane van der StratenPublished in: AIDS and behavior (2022)
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.
Keyphrases
- hiv testing
- open label
- men who have sex with men
- phase iii
- phase ii
- clinical trial
- study protocol
- hiv positive
- smoking cessation
- antiretroviral therapy
- hiv infected
- human immunodeficiency virus
- glycemic control
- hepatitis c virus
- hiv aids
- type diabetes
- squamous cell carcinoma
- emergency department
- healthcare
- randomized controlled trial
- polycystic ovary syndrome
- pregnant women
- drug induced
- south africa
- rectal cancer