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Table 1 Study overview: aims, rational, hypothesis, design and outcomes

From: The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol

 

Hypothesis

Rational

Study design and approach

Primary outcome

Secondary outcomes

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