Manicaland PrEP Uptake Through Interactive Counselling Trial
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ClinicalTrials.gov Identifier: NCT03565575 |
Recruitment Status :
Completed
First Posted : June 21, 2018
Last Update Posted : October 6, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
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Improving Perceptions of HIV Risk Improving Uptake of Pre-exposure Prophylaxis for HIV | Behavioral: Interactive tablet-based quiz | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1055 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Improving Risk Perception and Uptake of Pre-exposure Prophylaxis (PrEP) Through Interactive Feedback Based Counselling (and Community Engagement) in Young Women in Manicaland |
Actual Study Start Date : | July 7, 2018 |
Actual Primary Completion Date : | July 30, 2020 |
Actual Study Completion Date : | January 30, 2021 |

Arm | Intervention/treatment |
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Experimental: Interactive tablet-based quiz
Individuals participate in an interactive tablet-based risk perception and PrEP counselling information session.
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Behavioral: Interactive tablet-based quiz
Intervention participants play an interactive tablet based quiz including the following information components:
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. |
No Intervention: Control arm
No intervention will be administered to the control arm
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- Uptake of Pre-exposure prophylaxis for HIV [ Time Frame: 6 months ]The proportion of women taking up PrEP within 6 months measured with biomarkers of plasma ARV presence.
- Changes in perception of risk of HIV [ Time Frame: 6 months ]Risk perception with be measured in a follow-up survey at 6 months

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Ages Eligible for Study: | 18 Years to 24 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Participant eligibility is based on self-representation of gender identity. |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women
- Age 18-24 years
Exclusion Criteria:
- Participants testing HIV-positive at baseline
- Self-reporting taking PrEP at baseline

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565575
Zimbabwe | |
Manicaland Centre for Public Health Research | |
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 | |
Nyanga, Zimbabwe |
Principal Investigator: | Simon Gregson, PhD | Imperial College London |
Responsible Party: | Simon Gregson, Professor of Demography and Behavioural Science, Imperial College London |
ClinicalTrials.gov Identifier: | NCT03565575 |
Other Study ID Numbers: |
P67251_PrEP 1R01MH114562-01 ( U.S. NIH Grant/Contract ) |
First Posted: | June 21, 2018 Key Record Dates |
Last Update Posted: | October 6, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pre-Exposure Prophylaxis (PrEP) for HIV Risk perception HIV |