BACKGROUND: HPTN 084 demonstrated that long-acting injectable cabotegravir (CAB) was superior to daily oral TDF/FTC for HIV prevention in individuals born female. In 2022, following a protocol amendment, eligible participants were offered the choice of open-label CAB or TDF/FTC as PrEP in an open-label extension (OLE).
METHODS: In HPTN 084 participants who were eligible for (n=3028) and accepted OLE participation (n=2472), we assessed initial PrEP choice and reasons. We used the Decisional Conflict Scale to measure perceptions of effective decision-making (0=no conflict and 100=high decisional conflict). We compared participant demographic, behavioral and decision characteristics by initial product choice using chi-squared tests.
RESULTS: Of 2472 participants, 1931 (78%) chose CAB and 536 (22%) chose TDF/FTC. Among those initially randomized to TDF/FTC (n=1219), 817 (67%) chose CAB with 177 (15%) choosing the oral lead-in and 640 (53%) preferring direct-to-inject. Among those initially randomized to CAB (n=1253), 131 (11%) chose TDF/FTC. Participants who chose CAB (n=1931) preferred injections (77%), desired a convenient or discrete PrEP method (11%), valued CAB effectiveness (8%) or gave other/no reasons (4%). Those that chose TDF/FTC (n=536) preferred pills (81%), feared injection pain or side effects (5%), desired pregnancy (1%) or efficient clinic visits (1%), or gave no reason (12%). Product choice varied by country (p<0.001). Participants who chose CAB were more likely to be sexually active but not live with partner (p<0.025), to have experienced recent physical intimate partner violence (p<0.013) and to have been paid for sex (0.002). Although overall decision conflict scores were low and similar between groups (CAB 14; TDF/FTC16; p=0.9), effective decision sub-score differences suggest CAB users perceived more strongly that they had made a good decision (CAB 6; TDF/FTC 13; p 0.011). While most participants (66%) reported their choice was their own, discussions with study staff (20%) or family and friends (11%) were also influential.
CONCLUSIONS: The majority of HPTN 084 participants chose CAB for PrEP. Product choice was influenced by personal preference for product attributes, participant risk behaviours and social context. Future PrEP programs will need to adopt strategies that align user values and preferences with product choices.