Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-17

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe

NCT06770101

HIV Suicide

RECRUITING NA

Integrating Mental Health Into a HIV Clinic to Improve Outcomes Among Tanzanian Youth

NCT02888288

Health Behavior HIV Mental Health

COMPLETED NA

HIV Suicide Prevention With AI-DBT

NCT07339189

Suicidal Ideation and Behavior HIV AIDS (Acquired Immune Deficiency Syndrome)

RECRUITING NA

HIV Prevention for PLHIV: Evaluation of an Intervention Toolkit for HIV Care & Treatment Settings

NCT01256463

HIV

COMPLETED NA

Optimizing Care Delivery to Support Reengagement in PLWH Returning to HIV Care After Treatment Lapses in Zambia

NCT06803316

HIV Antiretroviral Therapy (ART) Adherence

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

IDEAS for Hope

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Enhanced Standard of Care (Safety Planning)

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No