Clinical trial NCT04696861: Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
Official title: Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicidal Ideation
HIV Infections
Adherence, Medication
Treatment Adherence and Compliance
Stigma, Social
Disclosure
Quality of Life
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Kilimanjaro Christian Medical Centre, Tanzania
First posted: 2021-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Suicidal Ideation
timeFrame: 3 months post enrollment
measure: Number of Participants With a Gap in HIV Care Engagement
timeFrame: 3 months post enrollment
measure: HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges
timeFrame: 3 months post enrollment
measure: Viral Load
timeFrame: Baseline, 3 months Post Enrollment
Secondary outcomes:
measure: Depression
timeFrame: 3 months post enrollment
measure: HIV Stigma
timeFrame: 3 months post enrollment
measure: Number of HIV Disclosures Made by Participants
timeFrame: 3 months post enrollment
measure: Total Number of HIV Disclosures Made by Participants
timeFrame: 3 months post enrollment
measure: Social Support
timeFrame: 3 months post enrollment
measure: Acceptability of Intervention
timeFrame: 3 months post enrollment
measure: Hopelessness
timeFrame: 3 months post enrollment
measure: Reasons for Living
timeFrame: 3 months post enrollment
measure: Quality of Life (Overall)
timeFrame: 3 months post enrollment
measure: Quality of Life (Health Satisfaction)
timeFrame: 3 months post enrollment
Other outcomes:
Locations:
city: Moshi
country: Tanzania
facility: Majengo Health Centre
city: Moshi
country: Tanzania
facility: Mawenzi Hospital
Study officials:
References: