Clinical trial NCT05374109: SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth
Official title: SYV: A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV-1-infection
Mental Health Issue
Adherence, Medication
Keywords: HIV-1
Adolescent
Youth
Mental Health
Africa
Tanzania
Medication Adherence
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Kilimanjaro Christian Medical Centre, Tanzania
name: National Institute for Medical Research, Tanzania
First posted: 2022-05-16
Enrollment: 690
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Virologic suppression as measured by percent of patients with a HIV RNA <400 copies/mL
timeFrame: 6 months post-baseline visit
Secondary outcomes:
measure: Change in virologic suppression as measured by percent of patients with a HIV RNA <400 copies/mL
timeFrame: Baseline, months 4 and 12 post-baseline visit
measure: Change in virologic suppression as measured by percent of patients with a HIV RNA <200 copies/mL
timeFrame: Baseline, months 4, 6 and 12 post-baseline visit
measure: Change in virologic suppression as measured by percent of patients with a HIV RNA <50 copies/mL
timeFrame: Baseline, months 4, 6 and 12 post-baseline visit
measure: Change in HIV RNA log scale
timeFrame: Baseline, months 4, 6 and12 post-baseline visit in SYV intervention compared to standard of care.
measure: Change in the percentage of patients who are HIV RNA undetectable (<400 copies m/L) as measured by blood test
timeFrame: Baseline, months 4, 6, 12 and 18 post-baseline visit
measure: Change in the percentage of patients who are HIV RNA detectable (>400 copies m/L) as measured by blood test
timeFrame: Baseline, months 4, 6, 12 and 18 post-baseline visit
measure: Change in anti-retroviral therapy (ART) adherence as measured by SYV (Sauti ya Vijana) Scale - Adherence section
timeFrame: Baseline, months 4, 6, 12 and 18 post-baseline visit
measure: Change in anti-retroviral therapy (ART) adherence as measured by concentration of ART medication(s) in hair sample
timeFrame: Baseline, months 4, 6, 12 and 18 post-baseline visit
measure: Change in mental health status as measured by SYV Scale - General Anxiety Disorder-7 (GAD-7) section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in mental health status as measured by SYV Scale - Patient Health Questionnaire-9 (PHQ-9) section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in mental health status as measured by SYV Scale - Strengths and Difficulties Questionnaire (SDQ) section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in mental health status as measured by SYV Scale - Self-Esteem section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in mental health status as measured by SYV Scale - Adverse Childhood Experiences International Questionnaire (ACE-IQ) section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in coping habits as measured by SYV Scale - Adverse Childhood Experiences International Questionnaire (ACE-IQ) section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in resilience as measured by SYV Scale - Adapted People Living with HIV Resilience Scale
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in stigma as measured by SYV Scale - Stigma section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in overall quality of life measured by SYV Scale - Quality of Life (QOL)
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in gender based violence as measured by SYV Scale - Violence against partner section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in gender based violence as measured by SYV Scale - Violence Perpetration section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in disclosure as measured by SYV Scale - Stigma section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in HIV knowledge as measured by SYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in sexual high-risk behaviors as measured by SYV Scale - Sexual section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
measure: Change in substance abuse high-risk behaviors as measured by SYV Scale - Personal section
timeFrame: Baseline, 4, 6, 12 and 18 months post-baseline visit
Other outcomes:
Locations:
city: Ifakara
country: Tanzania
facility: Chronic Disease Clinic of Ifakara Health Institute
city: Mbeya
country: Tanzania
facility: Baylor College of Medicine Children's Foundation - Tanzania, Mbeya Centre for Excellence
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre
city: Moshi
country: Tanzania
facility: Mawenzi Regional Referral Hospital
city: Mwanza
country: Tanzania
facility: Baylor College of Medicine Children's Foundation - Tanzania, Mwanza Centre for Excellence
city: Mwanza
country: Tanzania
facility: Bugando Medical Centre
Study officials:
affiliation: Duke University
name: Dorothy E Dow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
citation: 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.