Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,055

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

June 11, 2018

Completed

10 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed

16 days until next milestone

Study Start

First participant enrolled

July 7, 2018

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed

Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2.6 years

First QC Date

June 11, 2018

Last Update Submit

September 26, 2023

Conditions

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

Keywords

Pre-Exposure Prophylaxis (PrEP) for HIVRisk perceptionHIV

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Changes in perception of risk of HIV from age-disparate partnerships
6 months

Study Arms (2)

Interactive tablet-based quiz

EXPERIMENTAL

Individuals participate in an interactive tablet-based risk perception and PrEP counselling information session.

Behavioral: Interactive tablet-based quiz

Control arm

NO INTERVENTION

No intervention will be administered to the control arm

Interventions

Interactive tablet-based quizBEHAVIORAL

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.

Interactive tablet-based quiz

Eligibility Criteria

Age18 Years - 24 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsParticipant eligibility is based on self-representation of gender identity.

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Women
Age 18-24 years

You may not qualify if:

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

Contact the study team to confirm eligibility.