NCT05374109

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
690

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 16, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

May 6, 2022

Last Update Submit

January 23, 2025

Conditions

HIV-1-infectionMental Health IssueAdherence, Medication

Keywords

HIV-1AdolescentYouthMental HealthAfricaTanzaniaMedication Adherence

Outcome Measures

Primary Outcomes (1)

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

    HIV RNA measured by blood testing

    6 months post-baseline visit

Secondary Outcomes (23)

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

    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

    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

    Baseline, months 4, 6 and 12 post-baseline visit

  • Change in HIV RNA log scale

    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

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

  • +18 more secondary outcomes

Study Arms (2)

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

ACTIVE COMPARATOR

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)

SOC - Standard of Care

NO INTERVENTION

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.

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.

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

Eligibility Criteria

Age10 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Active psychosis
  • Developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chronic Disease Clinic of Ifakara Health Institute

Ifakara, Tanzania

Location

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

Mbeya, Tanzania

Location

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Location

Mawenzi Regional Referral Hospital

Moshi, Tanzania

Location

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

Mwanza, Tanzania

Location

Bugando Medical Centre

Mwanza, Tanzania

Location

Related Publications (4)

  • Dow DE, Mmbaga BT, Gallis JA, Turner EL, Gandhi M, Cunningham CK, O'Donnell KE. A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial. BMC Public Health. 2020 Sep 4;20(1):1358. doi: 10.1186/s12889-020-09380-3.

    PMID: 32887558BACKGROUND

  • Dow DE, Mmbaga BT, Turner EL, Gallis JA, Tabb ZJ, Cunningham CK, O'Donnell KE. Building resilience: a mental health intervention for Tanzanian youth living with HIV. AIDS Care. 2018;30(sup4):12-20. doi: 10.1080/09540121.2018.1527008. Epub 2019 Jan 9.

    PMID: 30626197BACKGROUND

  • Mollel GJ, Ketang'enyi E, Komba L, Mmbaga BT, Shayo AM, Boshe J, Knettel B, Gallis JA, Turner EL, O'Donnell K, Baumgartner JN, Ogbuoji O, Dow DE. Study protocol for Sauti ya Vijana (The Voice of Youth): A hybrid-type 1 randomized trial to evaluate effectiveness and implementation of a mental health and life skills intervention to improve health outcomes for Tanzanian youth living with HIV. PLoS One. 2024 Aug 26;19(8):e0305471. doi: 10.1371/journal.pone.0305471. eCollection 2024.

    PMID: 39186768BACKGROUND

  • Zimmerman A, Fawole A, Shahid M, Dow D, Ogbuoji O. Evidence Gaps in Economic Evaluations of HIV Interventions Targeting Young People: A Systematic Review. J Adolesc Health. 2024 Nov;75(5):709-724. doi: 10.1016/j.jadohealth.2024.06.013. Epub 2024 Aug 13.

    PMID: 39140926BACKGROUND

Related Links

MeSH Terms

Conditions

Medication AdherencePsychological Well-Being

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorPersonal Satisfaction

Study Officials

  • Dorothy E Dow, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The research assistant asking participants questions and the statistician are masked (not aware to which group participants were randomized).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 16, 2022

Study Start

March 1, 2023

Primary Completion

January 11, 2025

Study Completion

January 6, 2026

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
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.
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.

Locations

TA(6)