Effectiveness of Smartphone Application for Adherence Support (Vuka+)

NCT06897059 | Completed

• 1 other identifier: D21-152
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Medication; Smartphone Application

Keywords

PrEP; HIV; smartphone

Outcome Measures

Primary Outcomes (1)

• PrEP adherence

  Adherence to PrEP was measured by tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS)

  3 months

Secondary Outcomes (2)

• Vuka+ app acceptability

  6 months

• Vuka+ app usability

  6 months

Study Arms (2)

Standard of Care

NO INTERVENTION

Participants received PrEP standard of care counselling per country guidelines

Vuka+ App

EXPERIMENTAL

Participants downloaded and accessed the Vuka+ application in addition to receiving PrEP standard of care counseling.

Other: Vuka+ application

Interventions

Vuka+ application OTHER

The Vuka+ smartphone app included PrEP daily reminders, tracking for pill taking, resources for sexual reproductive health including quizzes and articles, and chat access to other Vuka+ users and medical expert.

Vuka+ App

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Virginia Medical School: lead
• CONRAD: collaborator
• Desmond Tutu Health Foundation: collaborator
• Florida State University: collaborator
• University of North Carolina, Chapel Hill: collaborator
• United States Agency for International Development (USAID): collaborator
• Gilead Sciences: collaborator
• Old Dominion University: collaborator

Study Sites (1)

Desmond Tutu Health Foundation

Cape Town, South Africa

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Homaira Hanif, PhD

  CONRAD/EVMS

  PRINCIPAL INVESTIGATOR

• Kathryn Muessig, PhD

  FSU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: December 15, 2022
• Primary Completion: March 1, 2024
• Study Completion: November 8, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)