Improving risk perception and uptake of pre-exposure prophylaxis (PrEP) through interactive feedback-based counselling with and without community engagement in young women in Manicaland, East Zimbabwe: study protocol for a pilot randomized trial

Ranjeeta Thomas, Morten Skovdal, Matteo M Galizzi, Robin Schaefer, Louisa Moorhouse, Constance Nyamukapa, Rufurwokuda Maswera, Phyllis Mandizvidza, Timothy B Hallett, Simon Gregson, Ranjeeta Thomas, Morten Skovdal, Matteo M Galizzi, Robin Schaefer, Louisa Moorhouse, Constance Nyamukapa, Rufurwokuda Maswera, Phyllis Mandizvidza, Timothy B Hallett, Simon Gregson

Abstract

Background: HIV incidence in adolescent girls and young women remains high in sub-Saharan Africa. Progress towards uptake of HIV prevention methods remains low. Studies of oral pre-exposure prophylaxis (PrEP) have shown that uptake and adherence may be low due to low-risk perception and ambivalence around using antiretrovirals for prevention. No evidence exists on whether an interactive intervention aimed at adjusting risk perception and addressing the uncertainty around PrEP will improve uptake. This pilot research trial aims to provide an initial evaluation of the impact of an interactive digital tablet-based counselling session, correcting risk perception, and addressing ambiguity around availability, usability, and effectiveness of PrEP.

Methods/design: This is a matched-cluster randomized controlled trial which will compare an interactive tablet-based education intervention against a control with no intervention. The study will be implemented in eight sites. In each site, two matched clusters of villages will be created. One cluster will be randomly allocated to intervention. In two sites, a community engagement intervention will also be implemented to address social obstacles and to increase support from peers, families, and social structures. A total of 1200 HIV-negative young women aged 18-24 years, not on PrEP at baseline, will be eligible. Baseline measures of endpoints will be gathered in surveys. Follow-up assessment at six months will include biomarkers of PrEP uptake and surveys.

Discussion: This will be the first randomized controlled trial to determine whether interactive feedback counselling leads to uptake of HIV prevention methods such as PrEP and reduces risky sexual behavior. If successful, policymakers could consider such an intervention in school-based education campaigns or as post-HIV-testing counselling for young people.

Trial registration: Clinicaltrials.gov, NCT03565575. Registered on 21 June 2018.

Keywords: HIV prevention; Pre-exposure prophylaxis; Randomized trial; Zimbabwe.

Conflict of interest statement

SG declares shares in GlaxoSmithKline and AstraZeneca. TBH declares grants outside the subject area from: UNAIDS, WHO, BMGF, MRC. RT declares grants outside the subject area from EDCTP. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Study sites and patterns of HIV risk in AGYW in Manicaland, Zimbabwe: (a) study sites by type and location; (b) spatial pattern of HIV prevalence, 2009–2011; (c) trends in HIV incidence over time, 1998–2013; and (d) HIV prevalence by two-year age group
Fig. 3
Fig. 3
Intervention procedures
Fig. 4
Fig. 4
Timeline of study procedures

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