Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
- Conditions
- Health BehaviorHIVMental Health
- Interventions
- Behavioral: Mental Health InterventionBehavioral: Standard of Care
- Registration Number
- NCT02888288
- Lead Sponsor
- Duke University
- Brief Summary
The purpose of this study is to evaluate if a group-based mental health intervention called Sauti ya Vijana (The Voice of Youth) designed to address mental health challenges faced by adolescents in Tanzania is acceptable and feasible and if it improves mental health, antiretroviral therapy (ART) adherence, and virologic outcomes among HIV-positive adolescents as compared to youth receiving treatment as usual. Mental health intervention sessions will take place three times a month for approximately four months in groups of eight to ten youth based on age and sex. Caregivers will attend two sessions to support the youth and provide the guardian perspective on caring for HIV-positive adolescents. The investigator hypothesizes the mental health intervention will be acceptable, feasible, and will improve mental health and ART adherence among participating youth and this improvement will be sustained over time.
- Detailed Description
The study will enroll up to approximately 130 participants from the established Kilimanjaro Christian Medical Centre and Mawenzi Saturday Teen Clinics. Participants will be assigned to approximately eight to ten persons per group, based on age and sex. Groups will be matched in pairs as closely as possible (ex. two groups of females 12-16 years of age) and assigned to Wave 1, 2, or 3. Randomization will occur on the individual level and will occur just before the start of mental health intervention for each wave. Individuals will be randomized at this time point to reduce potential drop out of those with delayed start (Wave 2/3). Randomization will occur by a coin flip for two individuals based on alphabetical order: heads will be intervention group (I) and tails the standard of care group (SOC).
This feasibility study is longitudinal with up to 24 month follow-up after intervention. Feasibility measures from lay counselors will be monitored weekly. Outcome measures will be obtained by blinded interviewers using a structured survey to inquire about mental health symptoms, self-report adherence, obtain an ART drug concentration level from a hair sample, and HIV-1 viral load from a blood sample and will be collected by the same research assistants at five to six potential time points: 1) baseline, 2) pre-intervention, 3) post-intervention, 4) 6-months post-intervention, 5) 12-months post-intervention and 6) 24-months post-intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- Youth between the ages of 12 and 24 years of age, attending the Teen Club HIV clinic at Kilimanjaro Christian Medical Centre (KCMC) and/or Mawenzi Hospital and receiving ART
- if > or =l to 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 10 weekly CBT (SYV) sessions and 2 individual sessions.
- 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
- CROSSOVER
- Arm && Interventions
Group Intervention Description Mental Health Intervention Mental Health Intervention This arm was designed based on mental health needs of HIV-infected youth in Tanzania. It incorporates principles of cognitive behavioral therapy, interpersonal psychotherapy, and motivational interviewing built into 10 group sessions, approximately 90 minutes each (2 sessions with caregiver participation) and 2 individual sessions. Groups are age and gender matched and facilitated by lay counselors with a mix of lived experience and prior mental health research experience. Standard of Care Standard of Care This arm includes standard medical care and adherence counseling with routine education prior to the start of the HIV youth clinic from which participants are recruited.
- Primary Outcome Measures
Name Time Method Caregiver participation as measured by attendance sheet during 2 caregiver sessions Fidelity as measured by fidelity checklists weekly for 16 weeks during the intervention wave (over 2 years) Caregiver participation as measured by questionnaire during 2 caregiver sessions Record willingness of caregivers to participate (if unwilling, why not) and attendance.
Participant attendance weekly for 16 weeks during each intervention wave (over 2 years) Measure the percentage of participants who complete all intervention sessions and ability to interview participants for outcome measures over time.
Fidelity as measured by weekly supervisor meeting weekly for 16 weeks during the intervention wave (over 2 years)
- Secondary Outcome Measures
Name Time Method Change in Mental Health pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention Compare the change in standard deviation of mental health symptoms on the UCLA PTSD-RI, between the intervention group versus SOC.
Change in virologic outcomes pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention Describe the proportion of youth with viral suppression (HIV-1 RNA \< 400 copies/ml) in the intervention group and SOC.
Change in adherence (individual) baseline to post-intervention, 6-, 12-, and 24-months Compare the change in self-reported adherence and antiretroviral drug concentration in hair.
Change in mental health (individual) baseline to post-intervention, 6-, 12-,18- and 24-months Compare the change in standard deviation of mental health symptoms on the PHQ-9, SDQ, UCLA PTSD-RI at the individual level.
Change in ART adherence pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention Compare the change in self-report adherence between the intervention group versus SOC.
Compare method of adherence measurement pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention Compare self-report ART adherence with drug level concentration of hair samples.
Change in HIV viral load (individual) baseline to post-intervention, 6-, 12-, and 24-months Compare the change in HIV viral load.
Trial Locations
- Locations (1)
Kilimanjaro Christian Medical Centre
🇹🇿Moshi, Tanzania