Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

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).

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Moshi, Tanzania
    • Majengo Health Centre
  • Moshi, Tanzania
    • Mawenzi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Suicidal Ideation	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.	3 months post enrollment
Number of Participants With a Gap in HIV Care Engagement	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.	3 months post enrollment
HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges	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.	3 months post enrollment
Viral Load	Extraction of routine HIV viral load testing from the patient medical record at baseline and 3-months post study enrollment.	Baseline, 3 months Post Enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression	3 months post enrollment
HIV Stigma	HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma	3 months post enrollment
Social Support	Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support	3 months post enrollment
Acceptability of Intervention	10 items adapted from the Client Satisfaction Questionnaire (CSQ), score 10 to 40 with higher indicating greater satisfaction with the intervention	3 months post enrollment
Hopelessness	Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness	3 months post enrollment
Reasons for Living	Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live	3 months post enrollment
Number of HIV Disclosures Made by Participants	Self-reported disclosures to partner, family, friends, others (yes/no)	3 months post enrollment
Total Number of HIV Disclosures Made by Participants		3 months post enrollment
Quality of Life (Overall)	The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life	3 months post enrollment
Quality of Life (Health Satisfaction)	The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life	3 months post enrollment

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Mental Health (NIMH); Kilimanjaro Christian Medical Centre, Tanzania

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Actual): December 8, 2023
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: Pro00107424; K08MH124459 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No