Manicaland PrEP Uptake Through Interactive Counselling Trial
Condition: Improving Perceptions of HIV Risk; Improving Uptake of Pre-exposure Prophylaxis for HIV
Study type: Interventional

Summary: 
      Primary Objective:

      The purpose of this trial is to evaluate the impact of an interactive tablet based
      counselling session correcting risk perception and addressing ambiguity around availability,
      usability and effectiveness of PrEP on PrEP uptake within 6 months in adolescent girls and
      young women (AGYW) aged 18-24 years.

      Hypothesis:

      Correcting misperceptions of risks of HIV infection and off-setting ambiguity effects about
      the availability, usability and efficacy of PrEP, through localized, interactive,
      tablet-based counselling, will increase uptake of PrEP in HIV-negative AGYW.

      Study outcomes:

      The primary outcomes for the study will be risk perception measured in a follow-up survey at
      6 months and proportion of women taking up PrEP within 6 months measured with biomarkers of
      plasma antiretroviral (ARV) drug presence.
    

Detailed description: 
      With 6 clusters per arm, mean cluster size of 48 individuals, with co-efficient of variation
      in outcomes between 0.15 to 0.55, the trial will have 80% power to detect difference of 5 - 9
      percentage points when baseline PrEP uptake is assumed to be 1%.

      Primary analysis:

      A two-stage intention-to-treat (ITT) analysis of cluster level summaries will be used. The
      parameter of interest is the adjusted risk difference in primary and secondary outcomes.

      In the first stage, Logistic regression will be used to adjust for confounding variables at
      the individual level. The model will be fitted using data from both trial arms. The
      regression model will include terms for the covariates of interest and pair but not trial
      arm. Adjustment variables will include age group (<20, 20-24), highest level of education
      completed, marital status and baseline measures of outcomes. In the second stage, a formal
      statistical comparison for differences in observed versus expected uptake by arm will be
      conducted using a two-sided paired significance test with α=0.05.

      Secondary analysis:

      In secondary analysis, the complier average causal effect (CACE) will be estimated using an
      instrumental variables approach. The parameter of interest is the adjusted risk difference in
      primary and secondary outcomes.

      Heterogeneity by age and baseline levels of risk and time preferences will also be estimated.
    

Intervention name(s): Interactive tablet-based quiz
Intervention type(s): Behavioral
Intervention description(s): Intervention participants play an interactive tablet based quiz including the following information components:
Risks of HIV infection under different scenarios such as between two hypothetical individuals and with different behaviours.
Interactive counselling on key facts around PrEP, its usability and local availability
All individuals will have the option to sign up for contact by a nurse from the health clinic to discuss PrEP further and make an appointment for a visit. Participants will also be given a PrEP referral letter which they can present directly at one of the participating study clinics to begin PrEP. In two sites a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: matched-cluster randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pre-Exposure Prophylaxis (PrEP) for HIV; Risk perception; HIV