Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth

Duke University

Status: Completed

Conditions: HIV; Health Behavior; Mental Health

Treatments: Behavioral: Standard of Care; Behavioral: Mental Health Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02888288

Pro00069892

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 12 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Active psychosis, developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Mental Health Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mental Health Intervention

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of Care