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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

690 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth

NCT02888288

Health Behavior HIV Mental Health

COMPLETED NA

Strategies to AchieVe Viral Suppression for Youth With HIV

NCT06886971

Human Immunodeficiency Virus (HIV) Infection

RECRUITING NA

Intervention for Virologic Suppression in Youth

NCT05877729

HIV/AIDS Young Adult Mobile Health +2 more

ACTIVE_NOT_RECRUITING NA

Self- and Family-management Intervention in HIV+ Chinese Women

NCT03049332

Hiv

COMPLETED NA

Resilience-based Psychosocial Intervention Among Children Affected by HIV/AIDS

NCT04653441

Emotional Adjustment Aids/Hiv Problem

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV-1-infection Mental Health Issue Adherence, Medication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Restricted randomization will be used to balance the randomization across both study arms by site, sex, and enrollment HIV RNA (\<400 copies/mL or ≥400 copies/mL). Those randomized to receive the SYV intervention will be assembled into 33 groups of 10-11 participants per group. Those randomized to SOC will continue to receive routine care, which will be clearly defined by each site. The outcomes assessor and statisticians will be masked to participant study arm through the 6-month study visit (primary aim).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The research assistant asking participants questions and the statistician are masked (not aware to which group participants were randomized).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

SOC - Standard of Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

10 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No