MedPath

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

Not Applicable
Active, not recruiting
Conditions
HIV-1-infection
Mental Health Issue
Adherence, Medication
Registration Number
NCT05374109
Lead Sponsor
Duke University
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
690
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Virologic suppression as measured by percent of patients with a HIV RNA <400 copies/mL6 months post-baseline visit

HIV RNA measured by blood testing

Secondary Outcome Measures
NameTimeMethod
Change in virologic suppression as measured by percent of patients with a HIV RNA <400 copies/mLBaseline, months 4 and 12 post-baseline visit

HIV RNA measured by blood testing

Change in virologic suppression as measured by percent of patients with a HIV RNA <200 copies/mLBaseline, months 4, 6 and 12 post-baseline visit

HIV RNA measured by blood testing

Change in virologic suppression as measured by percent of patients with a HIV RNA <50 copies/mLBaseline, months 4, 6 and 12 post-baseline visit

HIV RNA measured by blood testing

Change in HIV RNA log scaleBaseline, months 4, 6 and12 post-baseline visit in SYV intervention compared to standard of care.

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 testBaseline, 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 testBaseline, 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 sectionBaseline, 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 sampleBaseline, 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) sectionBaseline, 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) sectionBaseline, 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) sectionBaseline, 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 sectionBaseline, 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) sectionBaseline, 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) sectionBaseline, 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 ScaleBaseline, 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 sectionBaseline, 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 sectionBaseline, 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 sectionBaseline, 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 sectionBaseline, 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) sectionBaseline, 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 sectionBaseline, 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 sectionBaseline, 4, 6, 12 and 18 months post-baseline visit

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

Trial Locations

Locations (6)

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, Tanzania

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