Manicaland PrEP Uptake Through Interactive Counselling Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Risk Perception and Uptake of Pre-exposure Prophylaxis (PrEP) Through Interactive Feedback Based Counselling (and Community Engagement) in Young Women in Manicaland

Conditions
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Improving Perceptions of HIV Risk, Improving Uptake of Pre-exposure Prophylaxis for HIV

Intervention / Treatment
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* Behavioral: Interactive tablet-based quiz


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women Age 18-24 years Exclusion Criteria: Participants testing HIV-positive at baseline Self-reporting taking PrEP at baseline

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: matched-cluster randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive tablet-based quiz<br>Individuals participate in an interactive tablet-based risk perception and PrEP counselling information session. | Behavioral: Interactive tablet-based quiz<br>* 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.<br>|
| No Intervention: Control arm<br>No intervention will be administered to the control arm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of Pre-exposure prophylaxis for HIV | The proportion of women taking up PrEP within 6 months measured with biomarkers of plasma ARV presence. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in perception of risk of HIV from age-disparate partnerships | Risk perception with be measured in a follow-up survey at 6 months with the following specific definitions Proportion of women correctly reporting a 25-29 year old man is more likely infected with HIV in Manicaland than a 15-19 year old man Proportion of women correctly reporting a 25-29 year old man is more likely infected with HIV in Manicaland than a 15-19 year old woman | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-Exposure Prophylaxis (PrEP) for HIV, Risk perception, HIV