NCT Number: NCT07064785
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.
This study is active but is not currently recruiting participants.
10 year and older
All sexes
Interventional
Not applicable
Balaka District Hospital, Balaka, Malawi
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Adolescents
Inclusion criteria
Treatment supporters
Inclusion criteria
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.
Time frame: By Week 24
Proportion of health facilities in the experimental arm that participated in implementation strategy.
Time frame: By Week 36
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.
Time frame: By Week 12
Proportion of eligible adolescents who enrolled in the study compared to the health facility register
Time frame: By Week 24
Proportion of adolescents and treatment supporters in the experimental arm who completed all activities.
Baylor College of Medicine
Other
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
Acronym: VS4A
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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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