Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Participants With Suicidal Ideation
研究概览
简要总结
The overall objectives of the proposed research are to develop a brief telehealth counseling intervention to provide support for people living with HIV and experiencing suicidal ideation, and to support HIV care engagement. The investigators hypothesize that a brief telehealth counseling intervention will be safe (participants in the clinical trial will not have increased risk of suicidal behavior), acceptable (high patient retention and satisfaction, high fidelity), and will demonstrate preliminary efficacy (reduced suicidal ideation, improved care engagement, improved mental well-being).
详细描述
The objective of the proposed research is to assess the feasibility and acceptability of a 3-session, nurse-delivered telehealth intervention to reduce suicidality and improve HIV care engagement among adults living with HIV in the Kilimanjaro Region of Tanzania. Suicide is a leading cause of death among people living with HIV (PLWH) worldwide and mental health disorders are key contributors to poor HIV care engagement, lower quality of life, higher transmission risk, and increased mortality among PLWH. Conversely, connecting PLWH with targeted mental health support improves these critical health outcomes. Telehealth counseling represents a cost-effective, innovative approach to mental health treatment in low-resource settings such as Tanzania, with the potential to expediently extend services. The proposed study will include Aim 1: Identifying the desired characteristics of a telehealth intervention for suicidality and HIV care engagement in the Tanzanian clinical context, Aim 2: Refining intervention content with support from a local study advisory board in Tanzania, and Aim 3: Testing the telehealth model in a pilot randomized control trial. Given emerging evidence for telehealth approaches to improve access to treatment and reduce health disparities, the intervention has great potential to support NIMH strategic objectives to address mental health comorbidities and strengthen the HIV care continuum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Attending HIV care at study clinic
- •Screen positive for suicidal ideation
- •Able to understand Kiswahili or English
- •Medically stable
- •Capable of providing informed consent to participate
排除标准
- •Under 18 years old
- •Unable to understand Kiswahili or English
- •Experiencing medical or psychiatric symptoms requiring immediate treatment
- •Incapable of providing informed consent to participate
结局指标
主要结局
Number of Participants With Suicidal Ideation
时间窗: 3 months post enrollment
Columbia-Suicide Severity Rating Scale (C-SSRS) items measuring suicidal thoughts (yes/no), intent (yes/no), and plan (yes/no). Reported here are the number of participants who responded 'yes' to each of the items.
Number of Participants With a Gap in HIV Care Engagement
时间窗: 3 months post enrollment
Participant medical records were reviewed after the 3-month follow-up survey to identify whether they had a gap in care during the study period, defined as 6 or more days where they did not have enough prescribed medication on hand to maintain adherence between HIV clinic appointments.
HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges
时间窗: 3 months post enrollment
During the baseline and follow-up surveys, participants were asked two questions related to their adherence to antiretroviral medication: "Think about the last 14 days. On how many days did you miss taking your HIV pill(s)?" and the same question with a 90 day recall period. Adherence challenges were coded yes/no at each time point, defined as (1) missing 3 or more days of medication in the past 14 days or (2) missing 6 or more days in the past 90 days.
Viral Load
时间窗: Baseline, 3 months Post Enrollment
Extraction of routine HIV viral load testing from the patient medical record at baseline and 3-months post study enrollment.
次要结局
- Depression(3 months post enrollment)
- HIV Stigma(3 months post enrollment)
- Number of HIV Disclosures Made by Participants(3 months post enrollment)
- Total Number of HIV Disclosures Made by Participants(3 months post enrollment)
- Social Support(3 months post enrollment)
- Acceptability of Intervention(3 months post enrollment)
- Hopelessness(3 months post enrollment)
- Reasons for Living(3 months post enrollment)
- Quality of Life (Overall)(3 months post enrollment)
- Quality of Life (Health Satisfaction)(3 months post enrollment)