For Aim 1, our primary outcome will be the proportion of eligible individuals accepting PrEP as part of CBCT services. Secondary outcomes will include (1) stratification of PrEP initiation by both location and CBCT platform; (2) in-depth qualitative understanding of PrEP initiation; (3) correlates of immediate, delayed, and no PrEP initiation; and (4) comparison of sexual behaviours, risk profiles, and self-perception of risk in immediate, delayed, and never acceptors. Using the IMB model to inform the selection of variables and contextualization of results, an assessment of determinants of PrEP uptake will include (1) socio-demographic factors, (2) risk behaviours, (3) self-perception of risk, (4) previous knowledge of PrEP and perception of those taking PrEP, (5) partner characteristics and HIV status, (6) HIV-related stigma, and (7) screening scores for depression, substance abuse, and social support. Baseline STIs will be used as an independent marker of sexual risk behaviour, and to validate self-reported sexual risk behaviours and self-perception of risk.

For Aim 2, the primary outcome will be a comparison of TFV-DP levels by study arm at months 3, 6, 12, 18, and 24, with a 12-month primary outcome and 24-month assessment of intervention durability. Based on cumulative adherence behaviour, as measured in iPrEX OLE [14], adherence will be categorized as (1) low adherence (≤ 3 tablets per week; ≤ 699 fmol/DBS punch), and (2) high adherence (4–7 tablets per week; ≥ 700 fmol/DBS punch). Analysis of primary outcomes will be conducted on an intention-to-treat basis. Secondary outcomes will include (1) predictors of PrEP adherence after adjusting for study arm, socio-demographic factors, exposure to adherence support activities, and risk profiles; (2) characterization of changes in sexual behaviours and risk profiles following PrEP initiation; (3) proportion of individuals who discontinue PrEP and factors associated with discontinuation; (4) proportion of individuals who discontinue but subsequently restart PrEP and characteristics associated with this subgroup; (5) factors associated with of patterns of PrEP use; and (6) profiles of individuals that may benefit more from group-based vs. individualized adherence support.

For Aim 3, we will estimate incremental costs relative to standard practice for the intervention. Micro-costing studies will use activity-based approaches for costs incurred (e.g. start-up activities, recruitment, service delivery, lab monitoring, adherence support, and PrEP) and costs averted (e.g. health costs saved by averting HIV infections). Adjusting for time spent on research activities (e.g. informed consent, research questionnaires), the total time required for the intervention will be estimated. Time and costs for PrEP delivery through community-based platforms will be estimated through staff interviews, accounting for time available for the intervention. Costs incurred by patients to access PrEP will be assessed through participant interviews. Furthermore, we will estimate the impact of PrEP strategies by measuring: (1) the difference in HIV incident cases among intervention and control arm participants, (2) changes in HIV incident cases at the population level, and (3) changes in disability-adjusted life years (DALYs) between intervention and control arm participants. The model simulates intervention impact and projects the effect on health outcomes over 10 years. Sensitivity analyses will explore the impact of PrEP uptake and adherence on model outcomes outside a study setting, reduction in HIV transmission due to ART adherence, and PrEP supply-chain interruptions.

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