Status:
COMPLETED
Effectiveness of Smartphone Application for Adherence Support (Vuka+)
Lead Sponsor:
Eastern Virginia Medical School
Collaborating Sponsors:
CONRAD
Desmond Tutu Health Foundation
Conditions:
Adherence, Medication
Smartphone Application
Eligibility:
FEMALE
15-24 years
Phase:
NA
Brief Summary
This is a Type I Hybrid effectiveness-implementation trial to evaluate an HIV Pre-Exposure Prophylaxis (PrEP) medication adherence, persistence and social support app (Vuka+) for adolescent girls and ...
Detailed Description
We will recruit 330 AGYW, aged 15-24 from the surrounding community, PrEP clinics and service providers in Cape Town, South Africa. If AGYW qualify for enrollment, they will be offered daily Truvada a...
Eligibility Criteria
Inclusion
- Assigned female at birth
- Age 15-24 years
- Healthy and weight at least 35kg
- Sexually active (had a male sexual partner in the past 6 months)
- Consistent access to a smartphone
- HIV-negative (clinic test)
- PrEP naive or no PrEP use in the past 6 months
- Eligible to start oral PrEP
Exclusion
- Unable to currently start PrEP
- Abnormal laboratory, medical, physical, or social finding which could impact study participation, by investigator discretion
- Unwilling or unable to provide informed consent
- Participating in another PrEP trial
- Unwilling to provide at least 2 forms of contact for follow-up
- Taking renal toxic medications
- Sexual partner known to be HIV-positive
Key Trial Info
Start Date :
December 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2024
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT06897059
Start Date
December 15 2022
End Date
November 8 2024
Last Update
March 26 2025
Active Locations (1)
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1
Desmond Tutu Health Foundation
Cape Town, South Africa