Hypothesis | Rational | Study design and approach | Primary outcome | Secondary outcomes | |
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Aim 1 | CBCT platforms will facilitate access to and initiation of PrEP by adolescent girls and young women | Numerous barriers exist that delay or inhibit YW’s access to clinic-based reproductive health and HIV prevention services | Cross-sectional, mixed methods. Integrate PrEP initiation services into CBCT pop-up testing sites and home-based testing platforms in extremely high HIV burden and under-researched rural and urban settings of South Africa | The proportion of eligible young women accepting PrEP as part of CBCT services | (1) PrEP initiation rates by a) community type (urban vs. rural), and b) CBCT platform (pop-up testing sites vs systematic home-based testing); (2) In-depth qualitative understanding of immediate, delayed and never accepting PrEP; (3) Socio-demographic and behavioural correlates of immediate, delayed and never initiating PrEP |
Aim 2 | Cognitive behavioural-based adherence support programmes will be associated with a substantial increase in prevention-effective use of PrEP compared to a control | Lack of PrEP efficacy in African YW in clinical trials was strongly associated with poor adherence. To maximize the prevention benefits of PrEP, scalable adherence support interventions are needed | Randomized controlled trial. Enrol and randomize PrEP-accepting young women to receive one of two adherence support interventions or standard care (basic adherence support) | Comparison of tenofovir-diphosphate concentration levels in dried blood spots by study arm, with a 12-month primary outcome and 24-month assessment of intervention durability | (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 that discontinue PrEP and factors associated with discontinuation; and (4) Qualitative description and factors associated with of patterns of PrEP use |
Aim 3 | Community-based PrEP initiation and adherence support platforms will increase uptake of and adherence to PrEP among YW, and cost-effectively avert HIV infections compared to standard practice | Evidence on cost and cost-effectiveness can be used by decision makers regarding the use of resources to support PrEP scale-up | Mathematical modelling and micro-costing studies. Estimate incremental costs and cost-effectiveness of community-based PrEP initiation and adherence support programmes among YW relative to standard practice. | Estimate the cost-effectiveness and budget impact of targeted PrEP initiation and adherence support | (1) Micro-costing studies will evaluate costs incurred and costs averted; (2) Estimate impact of support interventions on HIV incidence, HIV-related deaths and DALYs, using proportion on PrEP |