HIV/AIDSVS4ANCT07064785
Video-Intervention to Inspire Treatment Adherence for Life for Adolescents
A study testing Video-based ART adherence counseling in people with HIV/AIDS, run by Baylor College of Medicine at 32 sites in Malawi.
Trial summary
This a two-arm randomized controlled trial whose objective is to explore the impact of VITAL Start for Adolescents (VS4A), a video-based antiretroviral treatment (ART) adherence intervention, on a range of implementation and effectiveness outcomes. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Video-based ART adherence counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 32 sitesMalawi
- Study dates
- 25 Jul 2025to 28 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 10-19 years of age
- In care at the health facility
- Aware of their HIV status
- Provide informed consent (if aged 18+ years) or assent and guardian informed consent (if aged 10-17 years).
- Exclusion Criteria: if their ability to provide informed consent or assent is impaired
- Treatment supporters
Show all 10Show fewer
- >18 years old
- named as a treatment supporter of an adolescent study participant
- willing to provide informed consent for oneself
- Exclusion Criteria: if their ability to provide informed consent is impaired
Who cannot join
None listed.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Malawi32 sites
Balaka District Hospital
Balaka
Balaka OPD Health Centre
Balaka
Chiendausiku Health Centre
Balaka
Kalembo Health Centre
Balaka
Kwitanda Health Centre
Balaka
Mbera health Centre
Balaka
Namanolo Health Centre
Balaka
Nandumbo Health Centre
Balaka
Phalula Health Centre
Balaka
Phimbi Health Centre
Balaka
Ulongwe Health Centre
Balaka
Utale 2 Health Centre
Balaka
Chamba Health Centre
Machinga
Chikweo Health Centre
Machinga
Gawanani Health Centre
Machinga
Kawinga Dispensary
Machinga
Machinga Disctrict Hospital
Machinga
Machinga Health Centre
Machinga
Mangamba Health Centre
Machinga
Mbonechela Dispensary
Machinga
Mkwepere Health Centre
Machinga
Mpiri Health Centre
Machinga
Mposa Health Centre
Machinga
Namandanje Health Centre
Machinga
Namanja Health Centre
Machinga
Nayinunje Health Centre
Machinga
Nayuchi Health Centre
Machinga
Ngokwe Health Centre
Machinga
Nsanama Health Centre
Machinga
Ntaja Health Centre
Machinga
Nthorowa Health Centre
Machinga
Nyambi Health Centre
Machinga
About this study
Official title: VITAL Start (Video-Intervention to Inspire Treatment Adherence for Life) for Adolescents, a Randomized Controlled Trial of a Video Intervention to Improve Adherence, Retention, and Viral Load Suppression Among Adolescents Living With HIV
This a two-arm randomized controlled trial whose objective is to explore the impact of VITAL Start for Adolescents (VS4A), a video-based antiretroviral treatment (ART) adherence intervention, on a range of implementation and effectiveness outcomes. The study will be conducted in health facilities which provide HIV care to teens/adolescents in the Machinga and Balaka districts of Malawi with approximately 900 teens living with HIV and their treatment supporters (dyads). Dyads will be individually randomized on a 1:1 ratio to receive either the intervention or the standard of care. The VS4A intervention is designed to support Information, Motivation, and Behavioral skills (IMB) around adolescent ART adherence as well as strategies for enhancing treatment supporter social support. The intervention consists of: 1) a two-session video package with associated activities that both the adolescent and their treatment supporter will be asked to watch and participate in; 2) ART refill for the adolescent; 3) and intensive adherence counselling for those with a high viral load. The primary outcomes are adoption of the intervention and adolescent viral load suppression. The overall hypothesis is that VS4A will achieve high adoption and improve adolescent viral suppression.
Read the detailed description
Adolescents living with HIV (ALHIV)-an estimated 1.7 million globally-face ongoing challenges with HIV medication adherence, retention, and viral load suppression (VLS). With both high rates of incident infection and some of the lowest VLS rates, ALHIV experience high mortality with approximately 100 deaths per day. Successful interventions to improve retention and VLS among ALHIV in low- and middle-income countries (LMIC) remain limited. Video-based counseling interventions have improved HIV knowledge, disclosure, and treatment adherence in other populations and offer a scalable way to deliver standardized content while reducing health care worker burden. Yet, they remain underused for ALHIV in sub-Saharan Africa.
One of the first video-based interventions integrated into HIV care in Malawi was piloted with preliminary findings showing high satisfaction among patients and providers, as well as improvements in ART knowledge, adherence, and retention. Building on these results, the investigators propose to adapt and evaluate VITAL Start (Video-intervention to Inspire Treatment Adherence for Life) for Adolescents (VS4A), a video-based counseling package tailored for ALHIV.
Through a two-arm randomized controlled trial, the aim is to assess the impact of VS4A on implementation and clinical outcomes. Adolescent-treatment supporters from up to 26 health facilities in Malawi will be randomized to receive either the VS4 intervention or the standard of care (SOC). Implementation outcomes will be compared between the VS4A arm and the standard of care arm. The effectiveness outcome of adolescent viral suppression will be compared between the two arms.
The findings from this trial will provide an intervention that standardizes and improves knowledge and behavior at critical teaching moments through an engaging and culturally sensitive experience and inform scalable strategies to improve adolescent HIV care and advance progress toward long-term viral suppression and well-being for ALHIV.
- Conditions
- HIV/AIDS
- Being tested
- Video-based ART adherence counseling, Standard of Care (SOC)
- Keywords
- Adolescents, Children, Teens, Viral Suppression, Retention, Video, Intervention, Antiretroviral treatment, Counseling, Human Immunodeficiency Virus, Adherence, Health Education, Patient Compliance, Malawi, Self-efficacy, Social Support
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Health Education, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based ART adherence counselingBehavioural
- Clinical visit which includes ART provision at 0, 12 and 24 weeks
- Two one-hour video-based sessions with associated activities at 0 and 12 weeks
- Enhanced/Intensive adherence counselling with video component between 24-35 weeks for those with high viral load
Standard of Care (SOC)Behavioural
- Clinical visit which includes ART provision at 0, 12 and 24 weeks
- Basic adherence counselling between 24-35 weeks for those with high viral load
| Study group | Role | What they receive |
|---|---|---|
| Video-Based ART Adherence Counseling | Experimental | Not described Receives: Behavioral: Video-based ART adherence counseling |
| Standard of Care | Active comparator | Not described Receives: Behavioral: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Viral Load Measure
Adolescents will have their viral load assessed via dried blood spot. Results will be analyzed and those with a result of <1000 copies/ml will be considered virally suppressed. All others will be considered non-suppressed: >=1000 copies/ml or having no viral load measurement, lost, or died.
Measured: By 47 weeks
Adoption of VS4 intervention at teen club
Proportion of health facilities in the experimental arm that participated in implementation strategy.
Measured: By Week 24
Secondary outcomes (3)
Adolescent behavioral adherence
We are using a binary behavioral adherence measure. Considered behaviorally non-adherent if they indicated yes to any of the following: missed a dose in the past 3-days, missed a dose in the past 7-days or missed a clinic visit in the past year.
Measured: By Week 36
Reach
Proportion of eligible adolescents who enrolled in the study compared to the health facility register
Measured: By Week 12
Implementation fidelity
Proportion of adolescents and treatment supporters in the experimental arm who completed all activities.
Measured: By Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start25 Jul 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Saeed Ahmed, Baylor College of Medicine
- Investigators
- Saeed Ahmed, MD, MSc, Principal investigator, Baylor College of Medicine, Houston Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064785
- Sponsor's protocol ID
- H-53963
- Other IDs
- 5UG1MD019436-02
- Acronym
- VS4A
- Status last verified
- Apr 2026
- First submitted
- 7 Jul 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, all data will be de-identified and shared in compliance with all regulatory bodies and NIH data sharing procedures.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITAL Start (Video-Intervention to Inspire Treatment Adherence for Life) for Adolescents, a Randomized Controlled Trial of a Video Intervention to Improve Adherence, Retention, and Viral Load Suppression Among Adolescents Living With HIV
- ClinicalTrials.gov ID
- NCT07064785
- Acronym / sponsor ID
- VS4A / H-53963
- Conditions
- HIV/AIDS
- Keywords
- Adolescents, Children, Teens, Viral Suppression, Retention, Video, Intervention, Antiretroviral treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 15 Jul 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 a two-arm randomized controlled trial whose objective is to explore the impact of VITAL Start for Adolescents (VS4A), a video-based antiretroviral treatment (ART) adherence intervention, on a range of implementation and effectiveness outcomes. The study will be conducted in health facilities which provide HIV care to teens/adolescents in the Machinga and Balaka districts of Malawi with approximately 900 teens living with HIV and their treatment supporters (dyads). Dyads will be individually randomized on a 1:1 ratio to receive either the intervention or the standard of care. The VS4A intervention is designed to support Information, Motivation, and Behavioral skills (IMB) around adolescent ART adherence as well as strategies for enhancing treatment supporter social support. The intervention consists of: 1) a two-session video package with associated activities that both the adolescent and their treatment supporter will be asked to watch and participate in; 2) ART refill for the adolescent; 3) and intensive adherence counselling for those with a high viral load. The primary outcomes are adoption of the intervention and adolescent viral load suppression. The overall hypothesis is that VS4A will achieve high adoption and improve adolescent viral suppression.
Detailed description
Adolescents living with HIV (ALHIV)-an estimated 1.7 million globally-face ongoing challenges with HIV medication adherence, retention, and viral load suppression (VLS). With both high rates of incident infection and some of the lowest VLS rates, ALHIV experience high mortality with approximately 100 deaths per day. Successful interventions to improve retention and VLS among ALHIV in low- and middle-income countries (LMIC) remain limited. Video-based counseling interventions have improved HIV knowledge, disclosure, and treatment adherence in other populations and offer a scalable way to deliver standardized content while reducing health care worker burden. Yet, they remain underused for ALHIV in sub-Saharan Africa.
One of the first video-based interventions integrated into HIV care in Malawi was piloted with preliminary findings showing high satisfaction among patients and providers, as well as improvements in ART knowledge, adherence, and retention. Building on these results, the investigators propose to adapt and evaluate VITAL Start (Video-intervention to Inspire Treatment Adherence for Life) for Adolescents (VS4A), a video-based counseling package tailored for ALHIV.
Through a two-arm randomized controlled trial, the aim is to assess the impact of VS4A on implementation and clinical outcomes. Adolescent-treatment supporters from up to 26 health facilities in Malawi will be randomized to receive either the VS4 intervention or the standard of care (SOC). Implementation outcomes will be compared between the VS4A arm and the standard of care arm. The effectiveness outcome of adolescent viral suppression will be compared between the two arms.
The findings from this trial will provide an intervention that standardizes and improves knowledge and behavior at critical teaching moments through an engaging and culturally sensitive experience and inform scalable strategies to improve adolescent HIV care and advance progress toward long-term viral suppression and well-being for ALHIV.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-Based ART Adherence Counseling | Experimental | Behavioral: Video-based ART adherence counseling |
| Standard of Care | Active comparator | Behavioral: Standard of Care (SOC) |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 10-19 years of age
- In care at the health facility
- Aware of their HIV status
- Provide informed consent (if aged 18+ years) or assent and guardian informed consent (if aged 10-17 years).
- Exclusion Criteria: if their ability to provide informed consent or assent is impaired
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Video-based ART adherence counseling* Clinical visit which includes ART provision at 0, 12 and 24 weeks * Two one-hour video-based sessions with associated activities at 0 and 12 weeks * Enhanced/Intensive adherence counselling with video component between 24-35 weeks for those with high viral load | Behavioural | Video-Based ART Adherence Counseling |
| Standard of Care (SOC)* Clinical visit which includes ART provision at 0, 12 and 24 weeks * Basic adherence counselling between 24-35 weeks for those with high viral load | Behavioural | Standard of Care |
Primary outcome
Adolescent Viral Load Measure
Time frame: By 47 weeks
Adolescents will have their viral load assessed via dried blood spot. Results will be analyzed and those with a result of <1000 copies/ml will be considered virally suppressed. All others will be considered non-suppressed: >=1000 copies/ml or having no viral load measurement, lost, or died.
Adoption of VS4 intervention at teen club
Time frame: By Week 24
Proportion of health facilities in the experimental arm that participated in implementation strategy.
3 secondary outcomes
Adolescent behavioral adherence
Time frame: By Week 36
Reach
Time frame: By Week 12
Implementation fidelity
Time frame: By Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. At the end of the study, all data will be de-identified and shared in compliance with all regulatory bodies and NIH data sharing procedures.
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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.
Saeed Ahmed, MD, MSc principal investigator
Baylor College of Medicine, Houston Texas
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based ART adherence counseling in people with HIV/AIDS, run by Baylor College of Medicine at 32 sites in Malawi.
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 10 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Malawi. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adolescent Viral Load Measure (time frame: By 47 weeks). The study lists 2 primary outcomes in all. 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 20 Apr 2026.