Clinical trial NCT06897059: Effectiveness of Smartphone Application for Adherence Support (Vuka+)
Official title: Effectiveness of Smartphone Application (Vuka+) for Adherence Support in Adolescent Girls and Young Women -Type I Hybrid Implementation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Medication
Smartphone Application
Keywords: PrEP
HIV
smartphone
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
Collaborators: name: CONRAD
name: Desmond Tutu Health Foundation
name: Florida State University
name: University of North Carolina, Chapel Hill
name: United States Agency for International Development (USAID)
name: Gilead Sciences
name: Old Dominion University
First posted: 2025-03-26
Enrollment: 330
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 as PrEP. Participants will then be randomized 1:1 at baseline to SOC counselling and the Vuka+ intervention app or SOC counselling only (control). All participants will receive their regularly scheduled PrEP clinical care visits. At baseline, 1-, 3- and 6-month follow-up visits, participants will complete biobehavioral surveys, undergo HIV testing and pregnancy testing, and provide a urine (month 1 and 6) and DBS sample (months 1, 3 and 6) for tenofovir assessment. Intervention arm participants will also have the following study activities: install the intervention app on their phones at baseline study visit and be asked to use the intervention app for at least 5-10 minutes daily for 6 months. During this time, they will be prompted by the app to complete daily activities or health and wellness readings and to complete a weekly brief assessment related to their PrEP use. At follow-up study visits, intervention arm participants will complete an additional set of questions evaluating their app use experience and a subsample of participants will complete an in-depth qualitative exit interview to assess their app use experience, acceptability of the intervention and their evaluation of the app's content.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: PrEP adherence
timeFrame: 3 months
Secondary outcomes:
measure: Vuka+ app acceptability
timeFrame: 6 months
measure: Vuka+ app usability
timeFrame: 6 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation
Study officials:
affiliation: CONRAD/EVMS
name: Homaira Hanif, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: FSU
name: Kathryn Muessig, PhD
role: PRINCIPAL_INVESTIGATOR
References: