Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

Duke University

Status: Active, not recruiting

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

Treatments: Behavioral: IDEAS for Hope; Behavioral: Enhanced Standard of Care (Safety Planning)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04696861

Pro00107424

K08MH124459 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

IDEAS for Hope Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: IDEAS for Hope

Enhanced Standard of Care with Safety Planning

Active Comparator group

Description:

Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.

Treatment:

Behavioral: Enhanced Standard of Care (Safety Planning)