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 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 randomised 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. 1,200
HIV-negative young women 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 bio-markers 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
behaviour. If successful, policymakers could consider such an intervention in school-based education
campaigns or as post- HIV-testing counselling for young people.
Trial Registration
This trial has been registered on clinicaltrials.gov on 21/06/2018 (identifier: NCT03565575).
https://clinicaltrials.gov/ct2/show/NCT03565575