Manicaland PrEP Uptake Through Interactive Counselling Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Improving Perceptions of HIV Risk; Improving Uptake of Pre-exposure Prophylaxis for HIV
• Intervention / Treatment: Behavioral: Interactive tablet-based quiz

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.

• Study Type: Interventional
• Enrollment (Actual): 1055
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zimbabwe
  • Nyanga, Zimbabwe
    • Manicaland Centre for Public Health Research
  • Manicaland
    • Bonda, Manicaland, Zimbabwe
      • Manicaland Centre for Public Health Research
    • Eastern Highlands, Manicaland, Zimbabwe
      • Manicaland Centre for Public Health Research
    • Hobhouse, Manicaland, Zimbabwe
      • Manicaland Centre for Public Health Research
    • Honde, Manicaland, Zimbabwe
      • Manicaland Centre for Public Health Research
    • Nyazura, Manicaland, Zimbabwe
      • Manicaland Centre for Public Health Research
    • Sakubva, Manicaland, Zimbabwe
      • Manicaland Centre for Public Health Research
    • Selbourne, Manicaland, Zimbabwe
      • Manicaland Centre for Public Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women
• Age 18-24 years

Exclusion Criteria:

• Participants testing HIV-positive at baseline
• Self-reporting taking PrEP at baseline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Simon Gregson
• Collaborators: National Institute of Mental Health (NIMH); University of Copenhagen; London School of Economics and Political Science; Biomedical Research and Training Institute, Zimbabwe
• Investigators: Principal Investigator: Simon Gregson, PhD, Imperial College London

Publications and helpful links

General Publications

• Thomas R, Skovdal M, Galizzi MM, Schaefer R, Moorhouse L, Nyamukapa C, Maswera R, Mandizvidza P, Hallett TB, Gregson S. 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. Trials. 2019 Dec 2;20(1):668. doi: 10.1186/s13063-019-3791-8.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2018
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Risk perception; Pre-Exposure Prophylaxis (PrEP) for HIV
• Other Study ID Numbers: P67251_PrEP; 1R01MH114562-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No