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

July 9, 2026 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

690

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Ifakara, Tanzania
        • Chronic Disease Clinic of Ifakara Health Institute
      • Mbeya, Tanzania
        • Baylor College of Medicine Children's Foundation - Tanzania, Mbeya Centre for Excellence
      • Moshi, Tanzania
        • Kilimanjaro Christian Medical Centre
      • Moshi, Tanzania
        • Mawenzi Regional Referral Hospital
      • Mwanza, Tanzania
        • Bugando Medical Centre
      • Mwanza, Tanzania
        • Baylor College of Medicine Children's Foundation - Tanzania, Mwanza Centre for Excellence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virologic Suppression as Measured by Number of Participants With a HIV RNA <400 Copies/mL
Time Frame: 6 months post-baseline visit
HIV RNA measured by blood testing
6 months post-baseline visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Virologic Suppression as Measured by Percent of Patients With a HIV RNA <400 Copies/mL
Time Frame: Baseline, months 4 and 12 post-baseline visit
HIV RNA measured by blood testing
Baseline, months 4 and 12 post-baseline visit
Change in Virologic Suppression as Measured by Number of Participants With a HIV RNA <200 Copies/mL
Time Frame: Baseline, months 4, 6 and 12 post-baseline visit
HIV RNA measured by blood testing
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
Time Frame: Baseline, months 4, 6 and 12 post-baseline visit
HIV RNA measured by blood testing
Baseline, months 4, 6 and 12 post-baseline visit
Change in HIV RNA Log Scale
Time Frame: Baseline, months 4, 6 and12 post-baseline visit in SYV intervention compared to standard of care.
HIV RNA measured by blood testing
Baseline, months 4, 6 and12 post-baseline visit in SYV intervention compared to standard of care.
Change in Anti-retroviral Therapy (ART) Adherence as Measured by SYV (Sauti ya Vijana) Scale - Adherence Section
Time Frame: Baseline, months 4, 6, 12 and 18 post-baseline visit
SYV Scale - Adherence section (Likert scale - not applicable)
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
Time Frame: Baseline, month 6
hair samples sent for analysis
Baseline, month 6
Change in Mental Health Status as Measured by SYV Scale - General Anxiety Disorder-7 (GAD-7) Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
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
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Mental Health Status as Measured by SYV Scale - Patient Health Questionnaire-9 (PHQ-9) Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Patient Health Questionnaire-9 (PHQ-9) section (Likert scale 0 not at all to 3 nearly every day) 0 is the most positive choice
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Mental Health Status as Measured by SYV Scale - Strengths and Difficulties Questionnaire (SDQ) Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Strengths and Difficulties Questionnaire (SDQ) section (Likert scale 0 never true of me to 2 usually true of me) 0 or 2 can be most positive or most negative choices depending on the question
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Mental Health Status as Measured by SYV Scale - Self-Esteem Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Self-Esteem section (Likert scale - 4 options from strongly agree to strongly disagree - no choice is most positive)
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Coping Habits as Measured by SYV Scale - Adverse Childhood Experiences International Questionnaire (ACE-IQ) Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Adverse Childhood Experiences International Questionnaire (ACE-IQ) section (Likert scale - 5 options from Always to Never - Never is the most positive choice, 5 options Many Times, A few times, Once, Never or Refused - Never is the most positive choice, 4 options None, Little, Much and Most - no choice is most positive and 3 options are Yes, No or Not Sure - No is the most positive choice)
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Resilience as Measured by SYV Scale - Adapted People Living With HIV Resilience Scale
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Adapted People Living with HIV Resilience Scale (Likert scale 5 options from strongly disagree to strongly agree - strongly agree is the most positive choice)
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Stigma as Measured by SYV Scale - Stigma Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Stigma section (Likert scale 1 strongly disagree to 4 strongly agree - no most positive choice)
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Overall Quality of Life Measured by SYV Scale - Quality of Life (QOL)
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Quality of Life (QOL) (Likert scale 5 options from very poor/very dissatisfied to very good/very satisfied - very good/very satisfied is the most positive choice)
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Gender Based Violence as Measured by SYV Scale - Violence Against Partner Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Violence against partner section (Likert scale Yes or No - No is the most positive choice)
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Gender Based Violence as Measured by SYV Scale - Violence Perpetration Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Violence Perpetration section (Likert scale Yes or No - No is the most positive choice)
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Disclosure as Measured by SYV Scale - Stigma Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Stigma section (Likert scale 1 strongly disagree to 4 strongly agree - strongly disagree is the most positive choice) and Sexual section (Likert scale - N/A)
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in HIV Knowledge as Measured by SYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) section (Likert scale True/False/I don't know - no most positive choice)
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Sexual High-risk Behaviors as Measured by SYV Scale - Sexual Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Sexual section (Likert scale - N/A)
Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Substance Abuse High-risk Behaviors as Measured by SYV Scale - Personal Section
Time Frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
SYV Scale - Personal section (Likert scale N/A)
Baseline, 4, 6, 12 and 18 months post-baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Mental Health (NIMH)
National Institute for Medical Research, Tanzania
Kilimanjaro Christian Medical Centre, Tanzania

Investigators

  • Principal Investigator: Dorothy E Dow, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

December 15, 2025

Study Registration Dates

First Submitted

May 6, 2022

First Submitted That Met QC Criteria

May 6, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00109309
  • 1R01MH124476-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD will be de-identified and deposited in data repository alongside supporting documentation including but not limited to: readme file(s), blank data collection instruments, codebook(s), and/or data management program code. Additionally, analytic datasets and associated code may be deposited in conjunction with publications to facilitate replication of results.

The data repository will be UNC Dataverse and the deposit will be part of the Adolescent Mental Health in Africa Network Initiative (AMANI) Dataverse (subject to change). A data curator will review the dataset prior to deposit in a repository to assess deductive disclosure risk. Terms of Use, a data use agreement, or other access restrictions may be implemented if limited access is determined appropriate for this study data; otherwise the data deposit within the repository will be open access.

IPD Sharing Time Frame

All collected IPD will be deposited in a repository within one year of the study's completion. It may be embargoed with the repository for a period of time to allow the study team to publish. Analytic datasets related to specific publications will be shared within one year of the publication date.

IPD Sharing Access Criteria

The mechanism for sharing data is deposit in a data repository. Terms of Use, a data use agreement, or other access restrictions may be implemented if limited access is determined appropriate for this study data; otherwise the data deposit within the repository will be open access. If any access restrictions apply, the study PI will be responsible for reviewing and approving requests by other researchers to access the data. Other researchers may use published data for purposes allowed under applicable Terms of Use, data use agreements, and any other relevant policy, regulatory or legal restrictions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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