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

Sponsor

Duke University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05374109

Collaborator

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

750

Enrollment

Locations

Arms

Anticipated Duration (Months)

150

Patients Per Site

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection Mental Health Issue Adherence, Medication	Behavioral: SYV: Sauti ya Vijana (The Voice of Youth intervention)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

Single (Outcomes Assessor)

Masking Description:

The research assistant asking participants questions and the statistician are masked (not aware to which group participants were randomized).

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
No Intervention: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Virologic suppression as measured by percent of patients with a HIV RNA <400 copies/mL [6 months post-baseline visit]
HIV RNA measured by blood testing

Secondary Outcome Measures

Change in virologic suppression as measured by percent of patients with a HIV RNA <400 copies/mL [Baseline, months 4, 12 and 18 post-baseline visit]
HIV RNA measured by blood testing
Change in the percentage of patients who are HIV RNA undetectable (<400 copies m/L) as measured by blood test [Baseline, months 4, 6, 12 and 18 post-baseline visit]
HIV RNA results
Change in the percentage of patients who are HIV RNA detectable (>400 copies m/L) as measured by blood test [Baseline, months 4, 6, 12 and 18 post-baseline visit]
HIV RNA results
Change in anti-retroviral therapy (ART) adherence as measured by SYV (Sauti ya Vijana) Scale - Adherence section [Baseline, months 4, 6, 12 and 18 post-baseline visit]
SYV Scale - Adherence section (Likert scale - not applicable)
Change in anti-retroviral therapy (ART) adherence as measured by concentration of ART medication(s) in hair sample [Baseline, months 4, 6, 12 and 18 post-baseline visit]
hair samples sent for analysis
Change in mental health status as measured by SYV Scale - General Anxiety Disorder-7 (GAD-7) section [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
Change in mental health status as measured by SYV Scale - Patient Health Questionnaire-9 (PHQ-9) section [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
Change in mental health status as measured by SYV Scale - Strengths and Difficulties Questionnaire (SDQ) section [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
Change in mental health status as measured by SYV Scale - Self-Esteem section [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)
Change in mental health status as measured by SYV Scale - Adverse Childhood Experiences International Questionnaire (ACE-IQ) section [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 - 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)
Change in coping habits as measured by SYV Scale - Adverse Childhood Experiences International Questionnaire (ACE-IQ) section [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)
Change in resilience as measured by SYV Scale - Adapted People Living with HIV Resilience Scale [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)
Change in stigma as measured by SYV Scale - Stigma section [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)
Change in overall quality of life measured by SYV Scale - Quality of Life (QOL) [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)
Change in gender based violence as measured by SYV Scale - Violence against partner section [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)
Change in gender based violence as measured by SYV Scale - Violence Perpetration section [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)
Change in disclosure as measured by SYV Scale - Stigma section [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)
Change in HIV knowledge as measured by SYV Scale - HIV Knowledge Questionnaire-18 (HIV-KQ-18) section [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)
Change in sexual high-risk behaviors as measured by SYV Scale - Sexual section [Baseline, 4, 6, 12 and 18 months post-baseline visit]
SYV Scale - Sexual section (Likert scale - N/A)
Change in substance abuse high-risk behaviors as measured by SYV Scale - Personal section [Baseline, 4, 6, 12 and 18 months post-baseline visit]
SYV Scale - Personal section (Likert scale N/A)

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Chronic Disease Clinic of Ifakara Health Institute	Ifakara	Tanzania
2	Baylor College of Medicine Children's Foundation - Tanzania, Mbeya Centre for Excellence	Mbeya	Tanzania
3	Kilimanjaro Christian Medical Centre	Moshi	Tanzania
4	Baylor College of Medicine Children's Foundation - Tanzania, Mwanza Centre for Excellence	Mwanza	Tanzania
5	Bugando Medical Centre	Mwanza	Tanzania