Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

• ClinicalTrials.gov Identifier: NCT04696861
• Recruitment Status: Not yet recruiting
• First Posted: January 6, 2021
• Last Update Posted: January 6, 2021
• Sponsor: Duke University
• Collaborators: National Institute of Mental Health (NIMH); Kilimanjaro Christian Medical Centre, Tanzania
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Suicide; Suicidal Ideation; HIV Infections; Adherence, Medication; Treatment Adherence and Compliance; Stigma, Social; Disclosure; Quality of Life	Behavioral: IDEAS for Hope; Behavioral: Enhanced Standard of Care (Safety Planning)	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
• Estimated Study Start Date: July 1, 2021
• Estimated Primary Completion Date: June 30, 2025
• Estimated Study Completion Date: June 30, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: IDEAS for Hope Intervention; 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; 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.
Active Comparator: Enhanced Standard of Care with Safety Planning; 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); Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Brandon Knettel, Ph.D.; 919-660-1218; brandon.knettel@duke.edu

Sponsors and Collaborators

Duke University

National Institute of Mental Health (NIMH)

Kilimanjaro Christian Medical Centre, Tanzania

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04696861
• Other Study ID Numbers: Pro00107424
• First Posted: January 6, 2021
• Last Update Posted: January 6, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Suicide; Suicidal Ideation; Self-Injurious Behavior; Behavioral Symptoms