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Video-Intervention to Inspire Treatment Adherence for Life for Adolescents

NCT ID: NCT07064785

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-25

Study Completion Date

2027-03-28

Brief Summary

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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.

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Detailed Description

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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

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
Data analysts and the study biostatistician will be masked to randomization arm until they have a locked dataset.

Study Groups

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Video-Based ART Adherence Counseling

Group Type EXPERIMENTAL

Video-based ART adherence counseling

Intervention Type BEHAVIORAL

* 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

Group Type ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type BEHAVIORAL

* 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

Interventions

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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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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).

* \>18 years old
* named as a treatment supporter of an adolescent study participant
* willing to provide informed consent for oneself

Exclusion Criteria

Treatment supporters
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Saeed Ahmed

Associate Professor of Pediatrics, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saeed Ahmed, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine, Houston Texas

Locations

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Balaka District Hospital

Balaka, , Malawi

Site Status RECRUITING

Balaka OPD Health Centre

Balaka, , Malawi

Site Status NOT_YET_RECRUITING

Chiendausiku Health Centre

Balaka, , Malawi

Site Status NOT_YET_RECRUITING

Kalembo Health Centre

Balaka, , Malawi

Site Status NOT_YET_RECRUITING

Kwitanda Health Centre

Balaka, , Malawi

Site Status NOT_YET_RECRUITING

Mbera health Centre

Balaka, , Malawi

Site Status RECRUITING

Namanolo Health Centre

Balaka, , Malawi

Site Status RECRUITING

Nandumbo Health Centre

Balaka, , Malawi

Site Status NOT_YET_RECRUITING

Phalula Health Centre

Balaka, , Malawi

Site Status RECRUITING

Phimbi Health Centre

Balaka, , Malawi

Site Status NOT_YET_RECRUITING

Ulongwe Health Centre

Balaka, , Malawi

Site Status RECRUITING

Utale 2 Health Centre

Balaka, , Malawi

Site Status RECRUITING

Chamba Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Chikweo Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Gawanani Health Centre

Machinga, , Malawi

Site Status RECRUITING

Kawinga Dispensary

Machinga, , Malawi

Site Status RECRUITING

Machinga Disctrict Hospital

Machinga, , Malawi

Site Status RECRUITING

Machinga Health Centre

Machinga, , Malawi

Site Status RECRUITING

Mangamba Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Mbonechela Dispensary

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Mkwepere Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Mpiri Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Mposa Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Namandanje Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Namanja Health Centre

Machinga, , Malawi

Site Status RECRUITING

Nayinunje Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Nayuchi Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Ngokwe Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Nsanama Health Centre

Machinga, , Malawi

Site Status RECRUITING

Ntaja Health Centre

Machinga, , Malawi

Site Status RECRUITING

Nthorowa Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Nyambi Health Centre

Machinga, , Malawi

Site Status NOT_YET_RECRUITING

Countries

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Malawi

Central Contacts

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Saeed Ahmed, MD, MSc

Role: CONTACT

[email protected]
+13474971049

Tapiwa Tembo, MSc

Role: CONTACT

[email protected]
+265 999 970 033

Facility Contacts

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Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Tapiwa Tembo, MSc

Role: primary

[email protected]
+265 999 970 033

Other Identifiers

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5UG1MD019436-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-53963

Identifier Type: -

Identifier Source: org_study_id

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