Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH124476-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Kilimanjaro Christian Medical Centre, Tanzania | OTHER |
| National Institute for Medical Research, Tanzania | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic Suppression as Measured by Number of Participants With a HIV RNA <400 Copies/mL | HIV RNA measured by blood testing | 6 months post-baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Virologic Suppression as Measured by Percent of Patients With a HIV RNA <400 Copies/mL | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dorothy E Dow, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chronic Disease Clinic of Ifakara Health Institute | Ifakara | Tanzania | ||||
| Baylor College of Medicine Children's Foundation - Tanzania, Mbeya Centre for Excellence |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32887558 | Background | 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. | |
| 30626197 | Background | 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. |
Not provided
Not provided
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.
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.
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.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ifakara SYV | Ifakara site participants randomized to Sauti ya Vijana (SYV) 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. |
| FG001 | Ifakara SOC | Ifakara site participants randomized to Standard of Care (SOC): 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. |
| FG002 | KCMC/Mawenzi SYV | KCMC/Mawenzi site participants randomized to Sauti ya Vijana (SYV) 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. |
| FG003 | KCMC/Mawenzi SOC | KCMC/Mawenzi site participants randomized to Standard of Care (SOC): 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. |
| FG004 | Mbeya SYV | Mbeya site participants randomized to Sauti ya Vijana (SYV) 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. |
| FG005 | Mbeya SOC | Mbeya site participants randomized to Standard of Care (SOC): 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. |
| FG006 | Mwanza SYV | Mwanza site participants randomized to Sauti ya Vijana (SYV) 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. |
| FG007 | Mwanza SOC | Mwanza site participants randomized to Standard of Care (SOC): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wave 1 |
|
| ||||||||||||||||||
| Wave 2 |
| |||||||||||||||||||
| Wave 3 |
| |||||||||||||||||||
| Wave 4 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Virologic Suppression as Measured by Number of Participants With a HIV RNA <400 Copies/mL | HIV RNA measured by blood testing | Includes only participants with HIV RNA measurement at 6-month visit | Posted | Count of Participants | Participants | 6 months post-baseline visit |
|
Up to 6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for any reason | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression (PHQ-9 total score ≥ 10) | Psychiatric disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dorothy E. Dow, MD | Duke University | 919-684-6335 | dorothy.dow@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2024 | Jan 9, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 21, 2025 | Jan 9, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 30, 2022 | Dec 3, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
Not provided
Not provided
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).
Not provided
Not provided
The research assistant asking participants questions and the statistician are masked (not aware to which group participants were randomized).
|
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 | HIV RNA measured by blood testing | Baseline, months 4, 6 and 12 post-baseline visit |
| Change in HIV RNA Log Scale | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | SYV Scale - Personal section (Likert scale N/A) | Baseline, 4, 6, 12 and 18 months post-baseline visit |
| Mbeya |
| Tanzania |
| Kilimanjaro Christian Medical Centre | Moshi | Tanzania |
| Mawenzi Regional Referral Hospital | Moshi | Tanzania |
| Baylor College of Medicine Children's Foundation - Tanzania, Mwanza Centre for Excellence | Mwanza | Tanzania |
| Bugando Medical Centre | Mwanza | Tanzania |
| 39186768 | Background | 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. |
| 39140926 | Background | 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. |
| 41411241 | Background | 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. |
| 41662108 | Background | 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. |
| 40887090 | Result | 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. |
| 40528414 | Result | 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. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | Participants |
|
| OG001 | 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. |
|
|
|
| Secondary | Change in Virologic Suppression as Measured by Percent of Patients With a HIV RNA <400 Copies/mL | HIV RNA measured by blood testing | Not Posted | Baseline, months 4 and 12 post-baseline visit | Participants |
| Secondary | Change in Virologic Suppression as Measured by Number of Participants With a HIV RNA <200 Copies/mL | HIV RNA measured by blood testing | Not Posted | Baseline, months 4, 6 and 12 post-baseline visit | Participants |
| Secondary | Change in Virologic Suppression as Measured by Percent of Patients With a HIV RNA <50 Copies/mL | HIV RNA measured by blood testing | Not Posted | Aug 2026 | Baseline, months 4, 6 and 12 post-baseline visit | Participants |
| Secondary | Change in HIV RNA Log Scale | HIV RNA measured by blood testing | Not Posted | Baseline, months 4, 6 and12 post-baseline visit in SYV intervention compared to standard of care. | Participants |
| Secondary | 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) | Not Posted | Baseline, months 4, 6, 12 and 18 post-baseline visit | Participants |
| Secondary | Change in Anti-retroviral Therapy (ART) Adherence as Measured by Concentration of ART Medication(s) in Hair Sample | hair samples sent for analysis | Not Posted | Baseline, month 6 | Participants |
| Secondary | 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 | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | 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 | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | 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 | SDQ was included in the protocol in error. It was not administered as it is more tailored to a younger audience. No SDQ data were collected and no SDQ data will be reported. | Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit |
|
|
| Secondary | 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) | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | 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) | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | 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) | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | 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) | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | 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) | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | 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) | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | 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) | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | 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) | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | 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) | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | Change in Sexual High-risk Behaviors as Measured by SYV Scale - Sexual Section | SYV Scale - Sexual section (Likert scale - N/A) | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| Secondary | Change in Substance Abuse High-risk Behaviors as Measured by SYV Scale - Personal Section | SYV Scale - Personal section (Likert scale N/A) | Not Posted | Baseline, 4, 6, 12 and 18 months post-baseline visit | Participants |
| 1 |
| 349 |
| 7 |
| 349 |
| 53 |
| 349 |
| EG001 | 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. | 6 | 341 | 13 | 341 | 74 | 341 |
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
|
| Self harm - current | Psychiatric disorders | Non-systematic Assessment |
|
| Sexual abuse - current | Social circumstances | Non-systematic Assessment |
|
| Sexual abuse - past | Social circumstances | Non-systematic Assessment |
|
| Anxiety (GAD-7 total score ≥ 10) | Psychiatric disorders | Non-systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment |
|
| Concerns about mental health or home environment based on staff interaction | General disorders | Non-systematic Assessment |
|
| Domestic Disputes | Social circumstances | Non-systematic Assessment |
|
| Self harm - past | Psychiatric disorders | Non-systematic Assessment |
|
| Poor medication adherence | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D001519 | Behavior |
| D010549 | Personal Satisfaction |