Health Behavior, HIV, Mental Health
Conditions
Keywords
adolescent, adolescence, HIV/AIDS, mental health, cognitive behavioral therapy
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.
Interventions
BEHAVIORALMental Health Intervention
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.
BEHAVIORALStandard of Care
Standard of Care includes enhanced ART adherence based on clinic protocols and monthly HIV teaching sessions prior to adolescent clinic.
Sponsors
Kilimanjaro Christian Medical Centre, Tanzania
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 24 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Caregiver participation as measured by questionnaire | during 2 caregiver sessions | Record willingness of caregivers to participate (if unwilling, why not) and attendance. |
| Caregiver participation as measured by attendance sheet | during 2 caregiver sessions | — |
| Fidelity as measured by weekly supervisor meeting | weekly for 16 weeks during the intervention wave (over 2 years) | — |
| Fidelity as measured by fidelity checklists | weekly for 16 weeks during the intervention wave (over 2 years) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 PHQ-9, between the intervention group versus SOC. |
| Change in HIV viral load (individual) | baseline to post-intervention, 6-, 12-, and 24-months | Compare the change in HIV viral load. |
| 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. |
| 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. |
| 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 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. |
Countries
Tanzania
Outcome results
None listed