SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth

N/AActive Not RecruitingNCT05374109

Duke University690 enrolled

Overview

The overall objectives of this proposal are to support positive coping strategies that bolster mental health and lead to improved HIV outcomes among Young People Living with HIV (YPLWH). The central hypothesis is that SYV (Sauti ya Vijana, The Voice of Youth) will be effective to improve antiretroviral therapy (ART) adherence and virologic suppression in YPLWH in Tanzania. The rationale for this project is that by targeting mental health, which is strongly associated with medication adherence, that this will effectively improve adherence and thereby HIV viral suppression. The central hypothesis will be tested in three aims in a hybrid type-1 effectiveness-implementation trial.

The rigorous experimental design includes a pilot study followed by a parallel-arm randomized control trial (RCT). The pilot will include approximately eight consenting members of the youth community advisory board (CAB) at each site location prior to the RCT. If a youth CAB does not currently exist at each site, one will be formed. Although the investigators have strong pilot data for the SYV intervention from Moshi, the pilot test proposed herein will help ensure recruitment, enrollment, intervention delivery, supervision, measurement technology and logistics run as expected at each site (Moshi, Mbeya, Mwanza, Ifakara). The pilot study will be comprised of 8 participants recruited at each site. Subsequently, for the RCT, we will individually randomize up to 750 participants to receive the SYV intervention or SOC (standard of care) to achieve 90% power to detect a 10 percentage point difference between arms in the primary outcome of virologic suppression at the two-tailed 5% significance level, accounting for clustering by SYV group in the intervention arm. The intervention will be rolled out across four main sites, in four different Tanzanian regions, and in four waves separated in time by 6 months. There will be two SYV groups per wave at each site (\~8 groups per site) A study visit for all participants will be conducted baseline and approximately 4 months (T1), 6-, 12-, and 18-months post-baseline (T2, T3, T4) with 6-months post baseline being the primary endpoint. At 12 months post-baseline (T3), those randomized to the SYV intervention will receive a one-session SYV booster to improve content retention and study engagement as has been shown in prior studies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

SYV: Sauti ya Vijana (The Voice of Youth intervention)BEHAVIORAL

Mental health is associated with ART adherence and HIV outcomes. SYV was designed to address the specific challenges of young people living (YPLWH) with HIV in Tanzania. SYV includes 10 group sessions (two sessions held jointly with caregivers) lasting approximately 90 minutes and two individual sessions delivered by trained young adult group leaders who use a manualized protocol that is designed to scale in low resource settings. The intervention is applied to the Social Action Theory (SAT), a theoretical framework used to determine factors that influence health behavior. Building off a SAT resilience framework for YPLWH, components of evidence-based treatment models to influence cognitive, self, and social regulation to improve behavioral health outcomes will be strategically used.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 24 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Youth between the ages of 10 and 24 years of age * Attending the enrolling adolescent HIV clinic * Are fully disclosed and aware of their HIV status * Receiving ART for a minimum of 6 months * If ≥ 18 years, able to understand the project and provide written informed consent * If \<18 years, a parent or guardian must provide written permission and participant must be able to assent * All adolescents must also commit to attending the 10 weekly SYV sessions and 2 individual sessions Exclusion Criteria: * Active psychosis * Developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews

Locations (6)

Chronic Disease Clinic of Ifakara Health Institute

Ifakara, Tanzania

Baylor College of Medicine Children's Foundation - Tanzania, Mbeya Centre for Excellence

Mbeya, Tanzania

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Mawenzi Regional Referral Hospital

Moshi, Tanzania

Baylor College of Medicine Children's Foundation - Tanzania, Mwanza Centre for Excellence

Mwanza, Tanzania

Bugando Medical Centre

Mwanza, Tanzania

Outcomes

Primary Outcomes

Virologic suppression as measured by percent of patients with a HIV RNA <400 copies/mL

HIV RNA measured by blood testing

Time frame: 6 months post-baseline visit

Secondary Outcomes

Change in virologic suppression as measured by percent of patients with a HIV RNA <400 copies/mL

HIV RNA measured by blood testing

Time frame: Baseline, months 4 and 12 post-baseline visit

Change in virologic suppression as measured by percent of patients with a HIV RNA <200 copies/mL

HIV RNA measured by blood testing

Time frame: Baseline, months 4, 6 and 12 post-baseline visit

Change in virologic suppression as measured by percent of patients with a HIV RNA <50 copies/mL

HIV RNA measured by blood testing

Time frame: Baseline, months 4, 6 and 12 post-baseline visit

Change in HIV RNA log scale

HIV RNA measured by blood testing

Time frame: Baseline, months 4, 6 and12 post-baseline visit in SYV intervention compared to standard of care.

Change in the percentage of patients who are HIV RNA undetectable (<400 copies m/L) as measured by blood test

HIV RNA results

Time frame: Baseline, months 4, 6, 12 and 18 post-baseline visit

Change in the percentage of patients who are HIV RNA detectable (>400 copies m/L) as measured by blood test

HIV RNA results

Time frame: Baseline, months 4, 6, 12 and 18 post-baseline visit

Change in anti-retroviral therapy (ART) adherence as measured by SYV (Sauti ya Vijana) Scale - Adherence section

SYV Scale - Adherence section (Likert scale - not applicable)

Time frame: Baseline, months 4, 6, 12 and 18 post-baseline visit

Change in anti-retroviral therapy (ART) adherence as measured by concentration of ART medication(s) in hair sample

hair samples sent for analysis

Time frame: Baseline, months 4, 6, 12 and 18 post-baseline visit

Change in mental health status as measured by SYV Scale - General Anxiety Disorder-7 (GAD-7) section

SYV Scale - General Anxiety Disorder-7 (GAD-7) section (Likert scale 0 not at all to 3 nearly every day) 0 is the most positive choice