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

Duke University

Status: Active, not recruiting

Conditions: HIV-1-infection; Adherence, Medication; Mental Health Issue

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05374109

Pro00109309

1R01MH124476-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 690 patients

Sex: All

Ages: 10 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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690 participants in 2 patient groups

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

Active Comparator group

Description:

Sessions 1 to 3 - youth name their worries, discuss coping strategies, practice relaxation and breathing exercises, and learn components of cognitive behavioral therapy. Sessions 4 to 6 are dedicated to reflection and processing trauma. Caregivers (supportive adults) are invited at the discretion of enrolled youth to participate in Sessions 1 and 6. Session 7 - youth name their support network and any changes. Sessions 8 and 9 - youth consider stigma, disclosure, reproductive health, condom use, and gender-based violence. Sessions 9 and 10 expand the overall client-centered approach to emphasizing autonomy rather than imposing ideas about what the youth "should" do. In a final individual meeting, youth revisit their personal values, goals, and strategies for the next 6 months and review their support networks. A final gathering is used to review all session content, to celebrate all that has been shared and learned together, and to distribute certificates of completion.

Treatment:

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

SOC - Standard of Care

No Intervention group

Description:

Participants in the SOC will not meet in study groups, thus are more "at risk" for attrition. They will be contacted by the study team on a monthly basis to check in and ensure their documented contact information remains accurate. SOC may vary by site depending on clinic structure, referral systems, and group activities. These differences could potentially dilute the SYV intervention effect and introduce content spillover whereby participants randomized to the intervention discuss intervention content with participants randomized to SOC. As part of the study survey, participants will be asked if they had friends who attended the SYV intervention and if they discussed content. Additionally, as part of the implementation science outcomes (Aim 3), the SOC group structure, adherence counseling, and any mental health referrals offered as part of SOC will be documented.