Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

Conditions
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Suicide, Suicidal Ideation, HIV Infections, Adherence, Medication, Treatment Adherence and Compliance, Stigma, Social, Disclosure, Quality of Life

Intervention / Treatment
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* Behavioral: IDEAS for Hope
* Behavioral: Enhanced Standard of Care (Safety Planning)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who screen positive for suicidal ideation will be enrolled in the study, complete the baseline survey, and then randomly assigned to the intervention (3 sessions of counseling) or enhanced standard of care (brief safety planning).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDEAS for Hope Intervention<br>Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement. | Behavioral: IDEAS for Hope<br>* Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.<br>|
| Active Comparator: Enhanced Standard of Care with Safety Planning<br>Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning. | Behavioral: Enhanced Standard of Care (Safety Planning)<br>* Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal Ideation | Columbia-Suicide Severity Rating Scale (C-SSRS), 6 items, scale 0 to 6 with higher indicating more ideation | 3 months post enrollment | 
| HIV Care Engagement | Self-reported clinic attendance | 3 months post enrollment | 
| HIV Medication Adherence | Self-reported medication adherence | 3 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression | 3 months post enrollment | 
| HIV Stigma | HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma | 3 months post enrollment | 
| HIV Acceptance | Illness Cognition Questionnaire (ICQ), 6 items, score 0-18 with higher indicating more acceptance | 3 months post enrollment | 
| HIV Disclosure | Self-reported disclosure to partner, family, friends, others (yes/no) and total number of disclosures | 3 months post enrollment | 
| Social Support | Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support | 3 months post enrollment | 
| Attitudes About Antiretroviral Therapy | Beliefs About Medicine Questionnaire (BMQ), 10 items, score 10 to 50 with higher indicating more positive attitudes about medication | 3 months post enrollment | 
| Acceptability of Intervention | 10 items adapted from the Client Satisfaction Questionnaire (CSQ), score 10 to 40 with higher indicating greater satisfaction with the intervention | 3 months post enrollment | 
| Suicide Coping Self-Efficacy | Self-Efficacy to Avoid Suicidal Action (SEASA) Scale, 6 items, score 0 to 60 with higher indicating more coping self-efficacy | 3 months post enrollment | 
| Hopelessness | Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness | 3 months post enrollment | 
| Reasons for Living | Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live | 3 months post enrollment | 
| Anxiety | Brief Symptom Inventory Anxiety Subscale, 6 items, score 0 to 24 with higher indicating more anxiety | 3 months post enrollment | 
| Quality of Life (Overall and Health Satisfaction) | WHOQOL-BREF, 2 items, score 2 to 10 with higher indicating better quality of life | 3 months post enrollment |