Acceptability of injectable cabotegravir versus daily oral TDF/FTC for PrEP: lesson from HPTN 084

Title

Acceptability of injectable cabotegravir versus daily oral TDF/FTC for PrEP: lesson from HPTN 084

Presenter

Nomhle Khoza

Authors

E. Tolley (1,2), A. Bula (3), M. Chitukuta (4), J. Etima (5), N. Khoza * (6), E. Namey (1), D. Kemigisha (5), L. Makhale (6), M. Tsidya (3), L. Schrumpf (7), M. Hosseinipour (3), S. Delany- Moretlwe (6), HPTN 084 Study Team

Institutions

(1) FHI 360, Behavioral, Epidemiological & Clinical Sciences, Durham, United States, (2) University of North Carolina, Maternal and Child Health, Chapel Hill, United States, (3) UNC Project Malawi, Lilongwe, Malawi, (4) University of Zimbabwe, College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe, (5) Makerere University, Johns Hopkins University (MU-JHU) Research Collaboration, Kampala, Uganda, (6) Wits Reproductive Health & HIV Institute, Johannesburg, South Africa, (7) FHI 360, Science Facilitation, Durham, United States

BACKGROUND: HPTN 084, a multisite, double-blind, randomized Phase 3 trial, compared the safety and efficacy of a long-acting cabotegravir (CAB LA) injectable to daily oral TDF/FTC for prevention of HIV-1 in uninfected African women. Like a similar trial in MSM/TGW (HPTN 083), the trial was stopped early for demonstrating superiority of CAB LA over TDF/FTC in preventing HIV. The shortened timeline of these two trials has expedited the need to consider introduction strategies for different populations. We examine qualitative data from a four-country substudy nested within HPTN 084 to better understand acceptability of these two PrEP methods and considerations for CAB LA access among African women at risk of HIV.
METHODS: Qualitative research teams in Malawi, South Africa, Uganda and Zimbabwe conducted repeated, in-depth interviews with 68 women to understand beliefs about and experiences with trial products across individual, partner, community and clinical trial contexts. The research teams followed a four-step process to read transcripts, develop a codebook and apply codes in NVivo to transcripts with intermittent interrater reliability checks. We developed memos describing Sexual History, Product-related Acceptability, Adherence, Pregnancy, PrEP Use, and Clinical Trial Experiences. We classified participants as: self-declared sex work, transactional sex, non-transactional partners, and monogamy; summarizing information in Excel matrices to explore differences across risk categories related to product acceptability and other themes.
RESULTS: Participants overwhelmingly preferred IM injections to daily pills. Regardless of risk category, women liked the injectable's privacy from husbands, boyfriends, sexual clients or just 'nosey people'.At least half of participants worried about forgetting to take pills, describing previous mishaps with oral contraception or challenges with study pills. Late night work, unexpected travel or heavy drinking impeded pill adherence for some women. Descriptions of pain - the most common injectable concern ' were variable; other side effects were rarely mentioned. Women in high-risk categories were more likely to mention 'effectiveness' as a reason to prefer the injection, to have disclosed about study participation, and to know where they might access PrEP beyond the trial.
CONCLUSIONS: Women's desire for privacy and ease of use outweighed other injectable concerns, resulting in a strong preference for CAB LA.

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