Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

Not Applicable

Active, not recruiting

• Conditions: Suicidal Ideation; HIV Infections; Adherence, Medication; Quality of Life; Stigma, Social; Disclosure; Suicide; Treatment Adherence and Compliance
• Interventions: Behavioral: IDEAS for Hope; Behavioral: Enhanced Standard of Care (Safety Planning)

• Registration Number: NCT04696861
• Lead Sponsor: Duke University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Study Start: 2023-05-17
• Primary Completion: 2023-12-08
• Results First Submitted: 2024-07-30
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Results First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDEAS for Hope Intervention	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.
Enhanced Standard of Care with Safety Planning	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Suicidal Ideation	3 months post enrollment	Columbia-Suicide Severity Rating Scale (C-SSRS) items measuring suicidal thoughts (yes/no), intent (yes/no), and plan (yes/no). Reported here are the number of participants who responded 'yes' to each of the items.
Number of Participants With a Gap in HIV Care Engagement	3 months post enrollment	Participant medical records were reviewed after the 3-month follow-up survey to identify whether they had a gap in care during the study period, defined as 6 or more days where they did not have enough prescribed medication on hand to maintain adherence between HIV clinic appointments.
HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges	3 months post enrollment	During the baseline and follow-up surveys, participants were asked two questions related to their adherence to antiretroviral medication: "Think about the last 14 days. On how many days did you miss taking your HIV pill(s)?" and the same question with a 90 day recall period. Adherence challenges were coded yes/no at each time point, defined as (1) missing 3 or more days of medication in the past 14 days or (2) missing 6 or more days in the past 90 days.
Viral Load	Baseline, 3 months Post Enrollment	Extraction of routine HIV viral load testing from the patient medical record at baseline and 3-months post study enrollment.

Secondary Outcome Measures

Name	Time	Method
Depression	3 months post enrollment	Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression
HIV Stigma	3 months post enrollment	HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma
Number of HIV Disclosures Made by Participants	3 months post enrollment	Self-reported disclosures to partner, family, friends, others (yes/no)
Total Number of HIV Disclosures Made by Participants	3 months post enrollment
Social Support	3 months post enrollment	Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support
Acceptability of Intervention	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
Hopelessness	3 months post enrollment	Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness
Reasons for Living	3 months post enrollment	Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live
Quality of Life (Overall)	3 months post enrollment	The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life
Quality of Life (Health Satisfaction)	3 months post enrollment	The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life

Trial Locations

Locations (2)

Mawenzi Hospital; 🇹🇿 Moshi, Tanzania

Majengo Health Centre; 🇹🇿 Moshi, Tanzania