NCT06897059Completed
Effectiveness of Smartphone Application for Adherence Support (Vuka+)
Effectiveness of Smartphone Application (Vuka+) for Adherence Support in Adolescent Girls and Young Women -Type I Hybrid Implementation Trial
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
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 young women (AGYW) in South Africa. This 6-month, 2-arm effectiveness and implementation trial (standard of care \[SOC\] vs. intervention app) will assess acceptability, feasibility and effectiveness. In addition, we will gather information on intervention delivery and barriers and facilitators for real-world delivery to inform future implementation and scale up.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 330 (actual)
- First submitted
- 20 Mar 2025
- Start date
- 15 Dec 2022
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- Eastern Virginia Medical School
- NCT number
- NCT06897059
What you commit to
- Study type: Interventional
- Participants enrolled: 330
- From 15 Dec 2022 to the primary completion date, 1 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking renal toxic medications
Other illness
- Sexual partner known to be HIV-positive
Lab values
- Abnormal laboratory, medical, physical, or social finding which could impact study participation, by investigator discretion
Other
- Unable to currently start PrEP
- Unwilling or unable to provide informed consent
- Participating in another PrEP trial
- Unwilling to provide at least 2 forms of contact for follow-up
Who the study is looking for
- 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
Age in the registry: 15 years to 24 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Desmond Tutu Health Foundation Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.