Adherence, MedicationNCT06897059
Effectiveness of Smartphone Application for Adherence Support (Vuka+)
A study testing Vuka+ application in people with Adherence, Medication and Smartphone Application, run by Eastern Virginia Medical School at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adherence, Medication, Smartphone Application
- What is being tested?
- Vuka+ application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 Dec 2022to 8 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Adherence, Medication, Smartphone Application
- Being tested
- Vuka+ application
- Keywords
- PrEP, HIV, smartphone
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vuka+ applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Vuka+ application |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP adherence
Adherence to PrEP was measured by tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS)
Measured: 3 months
Secondary outcomes (2)
Vuka+ app acceptability
Questionnaires and in-depth interviews were used to assess the acceptability of the smartphone app in the study population.
Measured: 6 months
Vuka+ app usability
Quantitative self-reported usability measures (validated scales) were asked at follow-up visits.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start15 Dec 2022
- Primary completion1 Mar 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, MedicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- CONRAD, Desmond Tutu Health Foundation, Florida State University, University of North Carolina, Chapel Hill, United States Agency for International Development (USAID), Gilead Sciences, Old Dominion University
- Responsible party
- Sponsor
- Investigators
- Homaira Hanif, PhD, Principal investigator, CONRAD/EVMSKathryn Muessig, PhD, Principal investigator, FSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897059
- Sponsor's protocol ID
- D21-152
- Status last verified
- Jan 2025
- First submitted
- 20 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Smartphone Application (Vuka+) for Adherence Support in Adolescent Girls and Young Women -Type I Hybrid Implementation Trial
- ClinicalTrials.gov ID
- NCT06897059
- Acronym / sponsor ID
- D21-152
- Conditions
- Adherence, Medication, Smartphone Application
- Keywords
- PrEP, HIV, smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- CONRAD, Desmond Tutu Health Foundation, Florida State University, University of North Carolina, Chapel Hill, United States Agency for International Development (USAID), Gilead Sciences, Old Dominion University
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants received PrEP standard of care counselling per country guidelines |
| Vuka+ App | Experimental | Other: Vuka+ applicationParticipants downloaded and accessed the Vuka+ application in addition to receiving PrEP standard of care counseling. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vuka+ applicationThe 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. | Other | Vuka+ App |
Primary outcome
PrEP adherence
Time frame: 3 months
Adherence to PrEP was measured by tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS)
2 secondary outcomes
Vuka+ app acceptability
Time frame: 6 months
Vuka+ app usability
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Homaira Hanif, PhD principal investigator
CONRAD/EVMS
Kathryn Muessig, PhD principal investigator
FSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vuka+ application in people with Adherence, Medication and Smartphone Application, run by Eastern Virginia Medical School at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP adherence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.