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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05374109
• Other study ID #: Pro00109309
• Secondary ID: 1R01MH124476-01A
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: Stuart T Carr, BA
• Phone: 919 668-4849
• Email: stuart.carr[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objectives of this proposal are to support positive coping strategies that bolster mental health and lead to improved HIV outcomes among Young People Living with HIV (YPLWH). The central hypothesis is that SYV (Sauti ya Vijana, The Voice of Youth) will be effective to improve antiretroviral therapy (ART) adherence and virologic suppression in YPLWH in Tanzania. The rationale for this project is that by targeting mental health, which is strongly associated with medication adherence, that this will effectively improve adherence and thereby HIV viral suppression. The central hypothesis will be tested in three aims in a hybrid type-1 effectiveness-implementation trial.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: January 31, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• HIV-1-infection
• Mental Health Issue

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Tanzania	Chronic Disease Clinic of Ifakara Health Institute	Ifakara
Tanzania	Baylor College of Medicine Children's Foundation - Tanzania, Mbeya Centre for Excellence	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

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Kilimanjaro Christian Medical Centre, Tanzania, National Institute for Medical Research, Tanzania, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Tanzania, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic suppression as measured by percent of patients with a HIV RNA <400 copies/mL	HIV RNA measured by blood testing	6 months post-baseline visit
Secondary	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, 12 and 18 post-baseline visit
Secondary	Change in the percentage of patients who are HIV RNA undetectable (<400 copies m/L) as measured by blood test	HIV RNA results	Baseline, months 4, 6, 12 and 18 post-baseline visit
Secondary	Change in the percentage of patients who are HIV RNA detectable (>400 copies m/L) as measured by blood test	HIV RNA results	Baseline, months 4, 6, 12 and 18 post-baseline visit
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)	Baseline, months 4, 6, 12 and 18 post-baseline visit
Secondary	Change in anti-retroviral therapy (ART) adherence as measured by concentration of ART medication(s) in hair sample	hair samples sent for analysis	Baseline, months 4, 6, 12 and 18 post-baseline visit
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	Baseline, 4, 6, 12 and 18 months post-baseline visit
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	Baseline, 4, 6, 12 and 18 months post-baseline visit
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	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)	Baseline, 4, 6, 12 and 18 months post-baseline visit
Secondary	Change in mental health status 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 - Always 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 the 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
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)	Baseline, 4, 6, 12 and 18 months post-baseline visit
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)	Baseline, 4, 6, 12 and 18 months post-baseline visit
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)	Baseline, 4, 6, 12 and 18 months post-baseline visit
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)	Baseline, 4, 6, 12 and 18 months post-baseline visit
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)	Baseline, 4, 6, 12 and 18 months post-baseline visit
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)	Baseline, 4, 6, 12 and 18 months post-baseline visit
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)	Baseline, 4, 6, 12 and 18 months post-baseline visit
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)	Baseline, 4, 6, 12 and 18 months post-baseline visit
Secondary	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
Secondary	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

External Links

•   website with information regarding Sauti ya Vijana (The Voice of Youth)