An interventional study of SYV: Sauti ya Vijana (The Voice of Youth intervention) in HIV-1-infection, Mental Health Issue and Adherence, Medication, sponsored by Duke University. Completed at 6 sites in Tanzania. Open to participants aged 10 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
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.
223 studies on the registry are indexed under Medication Adherence; 108 are open to participants now.
This study's enrollment of 690 is above the median of 118 across 189 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
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)
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.
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.
Virologic Suppression as Measured by Number of Participants With a HIV RNA <400 Copies/mL
HIV RNA measured by blood testing
Time frame: 6 months post-baseline visit
Change in Virologic Suppression as Measured by Percent of Patients With a HIV RNA <400 Copies/mL
HIV RNA measured by blood testing
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
HIV RNA measured by blood testing
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
HIV RNA measured by blood testing
Time frame: Baseline, months 4, 6 and 12 post-baseline visit
Change in HIV RNA Log Scale
HIV RNA measured by blood testing
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
SYV Scale - Adherence section (Likert scale - not applicable)
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
hair samples sent for analysis
Time frame: 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
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
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
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
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
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
SYV Scale - Self-Esteem section (Likert scale - 4 options from strongly agree to strongly disagree - no choice is most positive)
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
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)
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
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)
Time frame: 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)
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)
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)
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
SYV Scale - Violence against partner section (Likert scale Yes or No - No is the most positive choice)
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
SYV Scale - Violence Perpetration section (Likert scale Yes or No - No is the most positive choice)
Time frame: 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)
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
SYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) section (Likert scale True/False/I don't know - no most positive choice)
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
SYV Scale - Sexual section (Likert scale - N/A)
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
SYV Scale - Personal section (Likert scale N/A)
Time frame: Baseline, 4, 6, 12 and 18 months post-baseline visit
| Milestone | Ifakara SYV | Ifakara SOC | KCMC/Mawenzi SYV | KCMC/Mawenzi SOC | Mbeya SYV | Mbeya SOC | Mwanza SYV | Mwanza SOC |
|---|---|---|---|---|---|---|---|---|
| Started | 22 | 22 | 23 | 21 | 22 | 22 | 22 | 22 |
| Completed | 19 | 15 | 21 | 12 | 21 | 21 | 19 | 13 |
| Not completed | 3 | 7 | 2 | 9 | 1 | 1 | 3 | 9 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 3 | 7 | 1 | 9 | 1 | 1 | 3 | 8 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Ifakara SYV | Ifakara SOC | KCMC/Mawenzi SYV | KCMC/Mawenzi SOC | Mbeya SYV | Mbeya SOC | Mwanza SYV | Mwanza SOC |
|---|---|---|---|---|---|---|---|---|
| Started | 22 | 22 | 18 | 20 | 22 | 24 | 22 | 23 |
| Completed | 22 | 21 | 17 | 18 | 20 | 22 | 20 | 21 |
| Not completed | 0 | 1 | 1 | 2 | 2 | 2 | 2 | 2 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 | 1 | 1 | 2 | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Milestone | Ifakara SYV | Ifakara SOC | KCMC/Mawenzi SYV | KCMC/Mawenzi SOC | Mbeya SYV | Mbeya SOC | Mwanza SYV | Mwanza SOC |
|---|---|---|---|---|---|---|---|---|
| Started | 20 | 20 | 21 | 21 | 23 | 21 | 21 | 23 |
| Completed | 20 | 20 | 17 | 18 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 4 | 3 | 23 | 21 | 21 | 23 |
| Withdrew: Death | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 4 | 2 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Premature study closure | 0 | 0 | 0 | 0 | 23 | 19 | 20 | 23 |
| Milestone | Ifakara SYV | Ifakara SOC | KCMC/Mawenzi SYV | KCMC/Mawenzi SOC | Mbeya SYV | Mbeya SOC | Mwanza SYV | Mwanza SOC |
|---|---|---|---|---|---|---|---|---|
| Started | 20 | 20 | 24 | 20 | 23 | 21 | 24 | 19 |
| Completed | 16 | 16 | 22 | 19 | 0 | 0 | 0 | 0 |
| Not completed | 4 | 4 | 2 | 1 | 23 | 21 | 24 | 19 |
| Withdrew: Death | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Premature study closure | 0 | 0 | 0 | 0 | 23 | 20 | 24 | 19 |
| Withdrew: Lost to follow-up | 4 | 2 | 2 | 1 | 0 | 0 | 0 | 0 |
HIV RNA measured by blood testing
| Participants | SYV: Sauti ya Vijana (The Voice of Youth Intervention) | SOC - Standard of Care |
|---|---|---|
| Virologic Suppression as Measured by Number of Participants With a HIV RNA <400 Copies/mL | 267 | 267 |
HIV RNA measured by blood testing
Results for this outcome have not been posted.
HIV RNA measured by blood testing
Results for this outcome have not been posted.
HIV RNA measured by blood testing
Results for this outcome have not been posted.
HIV RNA measured by blood testing
Results for this outcome have not been posted.
SYV Scale - Adherence section (Likert scale - not applicable)
Results for this outcome have not been posted.
hair samples sent for analysis
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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
No measurements were reported for this outcome.
SYV Scale - Self-Esteem section (Likert scale - 4 options from strongly agree to strongly disagree - no choice is most positive)
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
SYV Scale - Stigma section (Likert scale 1 strongly disagree to 4 strongly agree - no most positive choice)
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
SYV Scale - Violence against partner section (Likert scale Yes or No - No is the most positive choice)
Results for this outcome have not been posted.
SYV Scale - Violence Perpetration section (Likert scale Yes or No - No is the most positive choice)
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
SYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) section (Likert scale True/False/I don't know - no most positive choice)
Results for this outcome have not been posted.
SYV Scale - Sexual section (Likert scale - N/A)
Results for this outcome have not been posted.
SYV Scale - Personal section (Likert scale N/A)
Results for this outcome have not been posted.
Collected over Up to 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SYV: Sauti ya Vijana (The Voice of Youth Intervention) | 1/349 (0.3%) | 7/349 (2%) | 53/349 (15.2%) |
| SOC - Standard of Care | 6/341 (1.8%) | 13/341 (3.8%) | 74/341 (21.7%) |
| Event | SYV: Sauti ya Vijana (The Voice of Youth Intervention) | SOC - Standard of Care |
|---|---|---|
| Self harm - currentPsychiatric disorders | 1/349 | 8/341 |
| Sexual abuse - currentSocial circumstances | 4/349 | 4/341 |
| Suicide attemptPsychiatric disorders | 1/349 | 1/341 |
| Hospitalization for any reasonGeneral disorders | 1/349 | 0/341 |
| Event | SYV: Sauti ya Vijana (The Voice of Youth Intervention) | SOC - Standard of Care |
|---|---|---|
| Depression (PHQ-9 total score ≥ 10)Psychiatric Disorders | 16/349 | 20/341 |
| Sexual abuse - pastSocial Circumstances | 14/349 | 17/341 |
| Anxiety (GAD-7 total score ≥ 10)Psychiatric Disorders | 6/349 | 14/341 |
| Suicidal IdeationPsychiatric Disorders | 6/349 | 10/341 |
| Concerns about mental health or home environment based on staff interactionGeneral Disorders | 4/349 | 4/341 |
| Self harm - pastPsychiatric Disorders | 2/349 | 4/341 |
| Poor medication adherenceGeneral Disorders | 2/349 | 3/341 |
| Domestic DisputesSocial Circumstances | 3/349 | 2/341 |
| Age, Continuous(years) | SYV: Sauti ya Vijana (The Voice of Youth Intervention) | SOC - Standard of Care | Total |
|---|---|---|---|
| Mean | 17.5 ± 2.4 | 17.5 ± 2.5 | 17.5 ± 2.5 |
| Sex: Female, Male(Participants) | SYV: Sauti ya Vijana (The Voice of Youth Intervention) | SOC - Standard of Care | Total |
|---|---|---|---|
| Female | 177 | 170 | 347 |
| Male | 172 | 171 | 343 |
| Ethnicity (NIH/OMB)(Participants) | SYV: Sauti ya Vijana (The Voice of Youth Intervention) | SOC - Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 349 | 341 | 690 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SYV: Sauti ya Vijana (The Voice of Youth Intervention) | SOC - Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 349 | 341 | 690 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | SYV: Sauti ya Vijana (The Voice of Youth Intervention) | SOC - Standard of Care | Total |
|---|---|---|---|
| Tanzania | 349 | 341 | 690 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Analytic code
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