Manicaland PrEP Uptake Through Interactive Counselling Trial

NCT03565575 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1055

Last updated 2023-09-28

No results posted yet for this study

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.

Conditions

  • Improving Perceptions of HIV Risk
  • Improving Uptake of Pre-exposure Prophylaxis for HIV

Interventions

BEHAVIORAL

Interactive tablet-based quiz

Intervention participants play an interactive tablet based quiz including the following information components: 1. Risks of HIV infection under different scenarios such as between two hypothetical individuals and with different behaviours. 2. 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.

Sponsors & Collaborators

  • Biomedical Research and Training Institute, Zimbabwe

    collaborator OTHER
  • University of Copenhagen

    collaborator OTHER
  • London School of Economics and Political Science

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Simon Gregson

    lead OTHER

Principal Investigators

  • Simon Gregson, PhD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-07
Primary Completion
2021-01-30
Completion
2021-01-30

Countries

  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03565575 on ClinicalTrials.gov