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Completed

NCT Number: NCT06897059

Effectiveness of Smartphone Application for Adherence Support (Vuka+)

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.

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Key information

Conditions

Adherence, Medication Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Smartphone Application Treatment Adherence and Compliance

Age range

15 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Desmond Tutu Health Foundation

Cape Town, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PrEP adherence

    Time frame: 3 months

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

Secondary outcomes

  1. Vuka+ app acceptability

    Time frame: 6 months

    Questionnaires and in-depth interviews were used to assess the acceptability of the smartphone app in the study population.

  2. Vuka+ app usability

    Time frame: 6 months

    Quantitative self-reported usability measures (validated scales) were asked at follow-up visits.

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Collaborators

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

Registry information

Official study title

Effectiveness of Smartphone Application (Vuka+) for Adherence Support in Adolescent Girls and Young Women -Type I Hybrid Implementation Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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