Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Caregiver participation as measured by attendance sheet
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Active psychosis, developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews.
结局指标
主要结局
Caregiver participation as measured by attendance sheet
时间窗: during 2 caregiver sessions
Fidelity as measured by fidelity checklists
时间窗: weekly for 16 weeks during the intervention wave (over 2 years)
Caregiver participation as measured by questionnaire
时间窗: during 2 caregiver sessions
Record willingness of caregivers to participate (if unwilling, why not) and attendance.
Participant attendance
时间窗: 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
时间窗: weekly for 16 weeks during the intervention wave (over 2 years)
次要结局
- Change in virologic outcomes(pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention)
- Change in Mental Health(pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention)
- Change in adherence (individual)(baseline to post-intervention, 6-, 12-, and 24-months)
- Change in mental health (individual)(baseline to post-intervention, 6-, 12-,18- and 24-months)
- Change in ART adherence(pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention)
- Compare method of adherence measurement(pre-intervention, within 1 month post-intervention, 6- and 12- months post-intervention)
- Change in HIV viral load (individual)(baseline to post-intervention, 6-, 12-, and 24-months)