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Completed

NCT Number: NCT05374109

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

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.

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Key information

Conditions

HIV-1-infection Adherence, Medication Behavior Health Behavior Medication Adherence Mental Health Issue Patient Acceptance of Health Care Patient Compliance Personal Satisfaction Psychological Well-Being Treatment Adherence and Compliance

Age range

10 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chronic Disease Clinic of Ifakara Health Institute, Ifakara, Tanzania

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Youth between the ages of 10 and 24 years of age
  • Attending the enrolling adolescent HIV clinic
  • Are fully disclosed and aware of their HIV status
  • Receiving ART for a minimum of 6 months
  • If ≥ 18 years, able to understand the project and provide written informed consent
  • If <18 years, a parent or guardian must provide written permission and participant must be able to assent
  • All adolescents must also commit to attending the 10 weekly SYV sessions and 2 individual sessions

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Virologic Suppression as Measured by Percent of Patients With a HIV RNA <400 Copies/mL

    Time frame: Baseline, months 4 and 12 post-baseline visit

    HIV RNA measured by blood testing

  2. Change in Virologic Suppression as Measured by Number of Participants With a HIV RNA <200 Copies/mL

    Time frame: Baseline, months 4, 6 and 12 post-baseline visit

    HIV RNA measured by blood testing

  3. Change in Virologic Suppression as Measured by Percent of Patients With a HIV RNA <50 Copies/mL

    Time frame: Baseline, months 4, 6 and 12 post-baseline visit

    HIV RNA measured by blood testing

  4. Change in HIV RNA Log Scale

    Time frame: Baseline, months 4, 6 and12 post-baseline visit in SYV intervention compared to standard of care.

    HIV RNA measured by blood testing

  5. Change in Anti-retroviral Therapy (ART) Adherence as Measured by SYV (Sauti ya Vijana) Scale - Adherence Section

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

    SYV Scale - Adherence section (Likert scale - not applicable)

  6. Change in Anti-retroviral Therapy (ART) Adherence as Measured by Concentration of ART Medication(s) in Hair Sample

    Time frame: Baseline, month 6

    hair samples sent for analysis

  7. Change in Mental Health Status as Measured by SYV Scale - General Anxiety Disorder-7 (GAD-7) Section

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

    SYV Scale - General Anxiety Disorder-7 (GAD-7) section (Likert scale 0 not at all to 3 nearly every day) 0 is the most positive choice

  8. Change in Mental Health Status as Measured by SYV Scale - Patient Health Questionnaire-9 (PHQ-9) Section

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

    SYV Scale - Patient Health Questionnaire-9 (PHQ-9) section (Likert scale 0 not at all to 3 nearly every day) 0 is the most positive choice

  9. Change in Mental Health Status as Measured by SYV Scale - Strengths and Difficulties Questionnaire (SDQ) Section

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

    SYV Scale - Strengths and Difficulties Questionnaire (SDQ) section (Likert scale 0 never true of me to 2 usually true of me) 0 or 2 can be most positive or most negative choices depending on the question

  10. Change in Mental Health Status as Measured by SYV Scale - Self-Esteem Section

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

    SYV Scale - Self-Esteem section (Likert scale - 4 options from strongly agree to strongly disagree - no choice is most positive)

  11. Change in Coping Habits as Measured by SYV Scale - Adverse Childhood Experiences International Questionnaire (ACE-IQ) Section

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

    SYV Scale - Adverse Childhood Experiences International Questionnaire (ACE-IQ) section (Likert scale - 5 options from Always to Never - Never is the most positive choice, 5 options Many Times, A few times, Once, Never or Refused - Never is the most positive choice, 4 options None, Little, Much and Most - no choice is most positive and 3 options are Yes, No or Not Sure - No is the most positive choice)

  12. Change in Resilience as Measured by SYV Scale - Adapted People Living With HIV Resilience Scale

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

    SYV Scale - Adapted People Living with HIV Resilience Scale (Likert scale 5 options from strongly disagree to strongly agree - strongly agree is the most positive choice)

  13. Change in Stigma as Measured by SYV Scale - Stigma Section

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

    SYV Scale - Stigma section (Likert scale 1 strongly disagree to 4 strongly agree - no most positive choice)

  14. Change in Overall Quality of Life Measured by SYV Scale - Quality of Life (QOL)

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

    SYV Scale - Quality of Life (QOL) (Likert scale 5 options from very poor/very dissatisfied to very good/very satisfied - very good/very satisfied is the most positive choice)

  15. Change in Gender Based Violence as Measured by SYV Scale - Violence Against Partner Section

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

    SYV Scale - Violence against partner section (Likert scale Yes or No - No is the most positive choice)

  16. Change in Gender Based Violence as Measured by SYV Scale - Violence Perpetration Section

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

    SYV Scale - Violence Perpetration section (Likert scale Yes or No - No is the most positive choice)

  17. Change in Disclosure as Measured by SYV Scale - Stigma Section

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

    SYV Scale - Stigma section (Likert scale 1 strongly disagree to 4 strongly agree - strongly disagree is the most positive choice) and Sexual section (Likert scale - N/A)

  18. Change in HIV Knowledge as Measured by SYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) Section

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

    SYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) section (Likert scale True/False/I don't know - no most positive choice)

  19. Change in Sexual High-risk Behaviors as Measured by SYV Scale - Sexual Section

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

    SYV Scale - Sexual section (Likert scale - N/A)

  20. Change in Substance Abuse High-risk Behaviors as Measured by SYV Scale - Personal Section

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

    SYV Scale - Personal section (Likert scale N/A)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 16, 2022
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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