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

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.

Study Overview

• Status: Completed
• Conditions: Adherence, Medication; Smartphone Application
• Intervention / Treatment: Other: Vuka+ application

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.

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • Desmond Tutu Health Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Participants received PrEP standard of care counselling per country guidelines
Experimental: Vuka+ App; Participants downloaded and accessed the Vuka+ application in addition to receiving PrEP standard of care counseling.	Other: Vuka+ application; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP adherence	Adherence to PrEP was measured by tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vuka+ app acceptability	Questionnaires and in-depth interviews were used to assess the acceptability of the smartphone app in the study population.	6 months
Vuka+ app usability	Quantitative self-reported usability measures (validated scales) were asked at follow-up visits.	6 months

Collaborators and Investigators

• Sponsor: Eastern Virginia Medical School
• Collaborators: Gilead Sciences; United States Agency for International Development (USAID); University of North Carolina, Chapel Hill; Florida State University; CONRAD; Old Dominion University; Desmond Tutu Health Foundation
• Investigators: Principal Investigator: Homaira Hanif, PhD, CONRAD/EVMS; Principal Investigator: Kathryn Muessig, PhD, FSU

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): November 8, 2024

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: HIV; PrEP; smartphone
• Other Study ID Numbers: D21-152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No