HIV-1-infectionNCT05374109

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

A study testing SYV: Sauti ya Vijana (The Voice of Youth intervention) in people with HIV-1-infection and Mental Health Issue, run by Duke University at 6 sites in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 10 to 24 years
Conditions the study is for: HIV-1-infection, Mental Health Issue, Adherence, Medication
What is being tested?: SYV: Sauti ya Vijana (The Voice of Youth intervention)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 690 participants
Where: 6 sitesTanzania
Study dates: 1 Mar 2023to 15 Dec 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 24 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Tanzania6 sites

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

Other trials in Tanzania

About this study

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.

Read the 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.

Conditions: HIV-1-infection, Mental Health Issue, Adherence, Medication
Being tested: SYV: Sauti ya Vijana (The Voice of Youth intervention)
Keywords: HIV-1, Adolescent, Youth, Mental Health, Africa, Tanzania, Medication Adherence
Medical subject headings: Medication Adherence, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05374109
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (20)

Change in Virologic Suppression as Measured by Percent of Patients With a HIV RNA <400 Copies/mL
HIV RNA measured by blood testing
Measured: 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
HIV RNA measured by blood testing
Measured: 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
Measured: Baseline, months 4, 6 and 12 post-baseline visit
Change in HIV RNA Log Scale
HIV RNA measured by blood testing
Measured: 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
SYV Scale - Adherence section (Likert scale - not applicable)
Measured: 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
Measured: Baseline, month 6
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
Measured: 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
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
Measured: 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
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
Measured: Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Mental Health Status as Measured by SYV Scale - Self-Esteem Section
SYV Scale - Self-Esteem section (Likert scale - 4 options from strongly agree to strongly disagree - no choice is most positive)
Measured: 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
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)
Measured: 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
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)
Measured: Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Stigma as Measured by SYV Scale - Stigma Section
SYV Scale - Stigma section (Likert scale 1 strongly disagree to 4 strongly agree - no most positive choice)
Measured: Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Overall Quality of Life Measured by SYV Scale - Quality of Life (QOL)
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)
Measured: Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Gender Based Violence as Measured by SYV Scale - Violence Against Partner Section
SYV Scale - Violence against partner section (Likert scale Yes or No - No is the most positive choice)
Measured: Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Gender Based Violence as Measured by SYV Scale - Violence Perpetration Section
SYV Scale - Violence Perpetration section (Likert scale Yes or No - No is the most positive choice)
Measured: Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Disclosure as Measured by SYV Scale - Stigma Section
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)
Measured: 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
SYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) section (Likert scale True/False/I don't know - no most positive choice)
Measured: Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Sexual High-risk Behaviors as Measured by SYV Scale - Sexual Section
SYV Scale - Sexual section (Likert scale - N/A)
Measured: Baseline, 4, 6, 12 and 18 months post-baseline visit
Change in Substance Abuse High-risk Behaviors as Measured by SYV Scale - Personal Section
SYV Scale - Personal section (Likert scale N/A)
Measured: Baseline, 4, 6, 12 and 18 months post-baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202315 Dec 2025

First posted16 May 2022
Study start1 Mar 2023
Primary completion20 Dec 2024
Study completion15 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for HIV-1-infectionStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 690 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05374109
Sponsor's protocol ID: Pro00109309
Other IDs: 1R01MH124476-01A1
Status last verified: Apr 2026
First submitted: 6 May 2022
Last updated: 29 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 32887558
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.
PubMed 30626197
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.
PubMed 39186768
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.
PubMed 39140926
Fawole A, Zimmerman A, Bateganya M, Mmbaga BT, Dow D, Ogbuoji O. Cost of Sauti ya Vijana (SYV), a mental health intervention for young people living with HIV in Tanzania: Results from a pilot randomized controlled trial. PLOS Glob Public Health. 2025 Dec 18;5(12):e0005397. doi: 10.1371/journal.pgph.0005397. eCollection 2025.
PubMed 41411241
Agina C, Nasuwa F, Mosha J, Abdul N, Sanga E, Samson L, Ndelwa LA, Mmbaga BT, Baumgartner JN, Dow DE. Peer-led interventions: Exploring the peer group leader experience of delivering Sauti ya Vijana, a group-based mental health intervention for youth living with HIV in Tanzania. PLOS Ment Health. 2026 Jan 21;3(1):e0000512. doi: 10.1371/journal.pmen.0000512. eCollection 2026.
PubMed 41662108
Dow D, Rahim F, Nasuwa F, O'Donnell K, Baumgartner JN, Mmbaga B. Mental Health Care Gaps for Adolescents With HIV: Lessons From Tanzania and the United States. Pediatrics. 2025 Sep 1;156(Suppl 1):e2025070739D. doi: 10.1542/peds.2025-070739D.
PubMed 40887090
Chow D, Pronyk P, Mgimba R, Elimwaria W, Ndaki R, Ambokile A, Mmbaga BT, Dow D. Integrating a mental health referral system within adolescent HIV clinics in Tanzania. AIDS. 2025 Nov 1;39(13):1920-1925. doi: 10.1097/QAD.0000000000004279. Epub 2025 Jun 18.
PubMed 40528414

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth
ClinicalTrials.gov ID: NCT05374109
Acronym / sponsor ID: Pro00109309
Conditions: HIV-1-infection, Mental Health Issue, Adherence, Medication
Keywords: HIV-1, Adolescent, Youth, Mental Health, Africa, Tanzania, Medication Adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 690 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), Kilimanjaro Christian Medical Centre, Tanzania, National Institute for Medical Research, Tanzania
Study start: 1 Mar 2023 (actual)
Primary completion: 20 Dec 2024 (actual)
Study completion: 15 Dec 2025 (actual)
First posted: 16 May 2022 (actual)
Results: Posted 9 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: 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).

Arm	Type	Receives
SYV: Sauti ya Vijana (The Voice of Youth intervention)	Active comparator	Behavioral: 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.
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.

Who may qualify

Ages: 10 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	SYV: Sauti ya Vijana (The Voice of Youth intervention)

Primary outcome

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

20 secondary outcomes

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
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
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
Change in HIV RNA Log Scale
Time frame: 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
Change in Anti-retroviral Therapy (ART) Adherence as Measured by Concentration of ART Medication(s) in Hair Sample
Time frame: 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
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
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
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
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
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
Change in Stigma as Measured by SYV Scale - Stigma Section
Time frame: 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
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
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
Change in Disclosure as Measured by SYV Scale - Stigma Section
Time frame: 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
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
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

Results and safety

Results posted to the registry on 9 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ifakara SYV	22	19
Ifakara SOC	22	15
KCMC/Mawenzi SYV	23	21
KCMC/Mawenzi SOC	21	12
Mbeya SYV	22	21
Mbeya SOC	22	21
Mwanza SYV	22	19
Mwanza SOC	22	13

Primary outcome: Virologic Suppression as Measured by Number of Participants With a HIV RNA <400 Copies/mL

Time frame: 6 months post-baseline visit. Count of participants. Unit: Participants

Measure	SYV: Sauti ya Vijana (The Voice of Youth Intervention) n = 307	SOC - Standard of Care n = 300
Value	267	267

SYV: Sauti ya Vijana (The Voice of Youth Intervention) vs SOC - Standard of Care: Risk Ratio (RR): 0.98 (95% CI 0.93 to 1.04)

Population analysed: Includes only participants with HIV RNA measurement at 6-month visit

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SYV: Sauti ya Vijana (The Voice of Youth Intervention)	7 of 349 (2%)	53 of 349 (15.2%)	1 of 349
SOC - Standard of Care	13 of 341 (3.8%)	74 of 341 (21.7%)	6 of 341

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32887558Dow 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.
Background: PubMed 30626197Dow 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.
Background: PubMed 39186768Mollel 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.
Background: PubMed 39140926Zimmerman 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.
Background: PubMed 41411241Fawole A, Zimmerman A, Bateganya M, Mmbaga BT, Dow D, Ogbuoji O. Cost of Sauti ya Vijana (SYV), a mental health intervention for young people living with HIV in Tanzania: Results from a pilot randomized controlled trial. PLOS Glob Public Health. 2025 Dec 18;5(12):e0005397. doi: 10.1371/journal.pgph.0005397. eCollection 2025.
Background: PubMed 41662108Agina C, Nasuwa F, Mosha J, Abdul N, Sanga E, Samson L, Ndelwa LA, Mmbaga BT, Baumgartner JN, Dow DE. Peer-led interventions: Exploring the peer group leader experience of delivering Sauti ya Vijana, a group-based mental health intervention for youth living with HIV in Tanzania. PLOS Ment Health. 2026 Jan 21;3(1):e0000512. doi: 10.1371/journal.pmen.0000512. eCollection 2026.
Results publication: PubMed 40887090Dow D, Rahim F, Nasuwa F, O'Donnell K, Baumgartner JN, Mmbaga B. Mental Health Care Gaps for Adolescents With HIV: Lessons From Tanzania and the United States. Pediatrics. 2025 Sep 1;156(Suppl 1):e2025070739D. doi: 10.1542/peds.2025-070739D.
Results publication: PubMed 40528414Chow D, Pronyk P, Mgimba R, Elimwaria W, Ndaki R, Ambokile A, Mmbaga BT, Dow D. Integrating a mental health referral system within adolescent HIV clinics in Tanzania. AIDS. 2025 Nov 1;39(13):1920-1925. doi: 10.1097/QAD.0000000000004279. Epub 2025 Jun 18.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dorothy E Dow, MD principal investigator

Duke University

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SYV: Sauti ya Vijana (The Voice of Youth intervention) in people with HIV-1-infection and Mental Health Issue, run by Duke University at 6 sites in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Virologic Suppression as Measured by Number of Participants With a HIV RNA <400 Copies/mL (time frame: 6 months post-baseline visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05374109, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.