An interventional study of Mental Health Intervention and Standard of Care in Health Behavior, HIV and Mental Health, sponsored by Duke University. Completed at 1 site in Tanzania. Open to participants aged 12 Years to 24 Years. Per ClinicalTrials.gov, last updated 2022-10-07.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
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.
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Mental Health Intervention
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.
Behavioral: Standard of Care
Includes a standard format of greetings, review of last session content, homework discussion, new topic, assigning homework and ends with a fun activity, relaxation or game. First session is a joint session with youth and caregivers. Topics include common stresses and worries experienced by HIV+ youth; relaxation and coping techniques; cognitive behavioral triangle; story of finding out HIV status and if willing, to discuss this in an individual session, peer group session, and with caregiver; identify circles of support; discuss stigma and how to disclose HIV status to others; consider values, hopes and dreams for the future, and how to use this information to live positively with HIV. ART adherence is woven into case examples and discussions.
Standard of Care includes enhanced ART adherence based on clinic protocols and monthly HIV teaching sessions prior to adolescent clinic.
Participant attendance
Measure the percentage of participants who complete all intervention sessions and ability to interview participants for outcome measures over time.
Time frame: weekly for 16 weeks during each intervention wave (over 2 years)
Caregiver participation as measured by questionnaire
Record willingness of caregivers to participate (if unwilling, why not) and attendance.
Time frame: during 2 caregiver sessions
Caregiver participation as measured by attendance sheet
Time frame: during 2 caregiver sessions
Fidelity as measured by weekly supervisor meeting
Time frame: weekly for 16 weeks during the intervention wave (over 2 years)
Fidelity as measured by fidelity checklists
Time frame: weekly for 16 weeks during the intervention wave (over 2 years)
Change in Mental Health
Compare the change in standard deviation of mental health symptoms on the PHQ-9, between the intervention group versus SOC.
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in Mental Health
Compare the change in standard deviation of mental health symptoms on the SDQ, between the intervention group versus SOC.
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in Mental Health
Compare the change in standard deviation of mental health symptoms on the UCLA PTSD-RI, between the intervention group versus SOC.
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in ART adherence
Compare the change in self-report adherence between the intervention group versus SOC.
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in virologic outcomes
Describe the proportion of youth with viral suppression (HIV-1 RNA \< 400 copies/ml) in the intervention group and SOC.
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Compare method of adherence measurement
Compare self-report ART adherence with drug level concentration of hair samples.
Time frame: pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention
Change in mental health (individual)
Compare the change in standard deviation of mental health symptoms on the PHQ-9, SDQ, UCLA PTSD-RI at the individual level.
Time frame: baseline to post-intervention, 6-, 12-,18- and 24-months
Change in adherence (individual)
Compare the change in self-reported adherence and antiretroviral drug concentration in hair.
Time frame: baseline to post-intervention, 6-, 12-, and 24-months
Change in HIV viral load (individual)
Compare the change in HIV viral load.
Time frame: baseline to post-intervention, 6-, 12-, and 24-months
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