Clinical Trials Directory

Trials / Completed

CompletedNCT04696861

Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALIDEAS for HopeParticipants 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.
BEHAVIORALEnhanced 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.

Timeline

Start date
2023-05-17
Primary completion
2023-12-08
Completion
2025-03-31
First posted
2021-01-06
Last updated
2025-04-20
Results posted
2024-10-01

Locations

2 sites across 1 country: Tanzania

Source: ClinicalTrials.gov record NCT04696861. Inclusion in this directory is not an endorsement.

Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania (NCT04696861) · Clinical Trials Directory