Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
Primary Purpose
Suicide, Suicidal Ideation, HIV Infections
Status
Recruiting
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
IDEAS for Hope
Enhanced Standard of Care (Safety Planning)
Sponsored by
About this trial
This is an interventional supportive care trial for Suicide
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
Sites / Locations
- Majengo Health CentreRecruiting
- Mawenzi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IDEAS for Hope Intervention
Enhanced Standard of Care with Safety Planning
Arm Description
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.
Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.
Outcomes
Primary Outcome Measures
Suicidal Ideation
Columbia-Suicide Severity Rating Scale (C-SSRS), 6 items, scale 0 to 6 with higher indicating more ideation
HIV Care Engagement
Self-reported clinic attendance
HIV Medication Adherence
Self-reported medication adherence
Secondary Outcome Measures
Depression
Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression
HIV Stigma
HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma
HIV Acceptance
Illness Cognition Questionnaire (ICQ), 6 items, score 0-18 with higher indicating more acceptance
HIV Disclosure
Self-reported disclosure to partner, family, friends, others (yes/no) and total number of disclosures
Social Support
Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support
Attitudes About Antiretroviral Therapy
Beliefs About Medicine Questionnaire (BMQ), 10 items, score 10 to 50 with higher indicating more positive attitudes about medication
Acceptability of Intervention
10 items adapted from the Client Satisfaction Questionnaire (CSQ), score 10 to 40 with higher indicating greater satisfaction with the intervention
Suicide Coping Self-Efficacy
Self-Efficacy to Avoid Suicidal Action (SEASA) Scale, 6 items, score 0 to 60 with higher indicating more coping self-efficacy
Hopelessness
Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness
Reasons for Living
Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live
Anxiety
Brief Symptom Inventory Anxiety Subscale, 6 items, score 0 to 24 with higher indicating more anxiety
Quality of Life (Overall and Health Satisfaction)
WHOQOL-BREF, 2 items, score 2 to 10 with higher indicating better quality of life
Full Information
NCT ID
NCT04696861
First Posted
December 22, 2020
Last Updated
June 13, 2023
Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH), Kilimanjaro Christian Medical Centre, Tanzania
1. Study Identification
Unique Protocol Identification Number
NCT04696861
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH), Kilimanjaro Christian Medical Centre, Tanzania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicidal Ideation, HIV Infections, Adherence, Medication, Treatment Adherence and Compliance, Stigma, Social, Disclosure, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IDEAS for Hope Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Standard of Care with Safety Planning
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
IDEAS for Hope
Intervention Description
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
Intervention Name(s)
Enhanced Standard of Care (Safety Planning)
Intervention Description
Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.
Primary Outcome Measure Information:
Title
Suicidal Ideation
Description
Columbia-Suicide Severity Rating Scale (C-SSRS), 6 items, scale 0 to 6 with higher indicating more ideation
Time Frame
3 months post enrollment
Title
HIV Care Engagement
Description
Self-reported clinic attendance
Time Frame
3 months post enrollment
Title
HIV Medication Adherence
Description
Self-reported medication adherence
Time Frame
3 months post enrollment
Secondary Outcome Measure Information:
Title
Depression
Description
Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression
Time Frame
3 months post enrollment
Title
HIV Stigma
Description
HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma
Time Frame
3 months post enrollment
Title
HIV Acceptance
Description
Illness Cognition Questionnaire (ICQ), 6 items, score 0-18 with higher indicating more acceptance
Time Frame
3 months post enrollment
Title
HIV Disclosure
Description
Self-reported disclosure to partner, family, friends, others (yes/no) and total number of disclosures
Time Frame
3 months post enrollment
Title
Social Support
Description
Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support
Time Frame
3 months post enrollment
Title
Attitudes About Antiretroviral Therapy
Description
Beliefs About Medicine Questionnaire (BMQ), 10 items, score 10 to 50 with higher indicating more positive attitudes about medication
Time Frame
3 months post enrollment
Title
Acceptability of Intervention
Description
10 items adapted from the Client Satisfaction Questionnaire (CSQ), score 10 to 40 with higher indicating greater satisfaction with the intervention
Time Frame
3 months post enrollment
Title
Suicide Coping Self-Efficacy
Description
Self-Efficacy to Avoid Suicidal Action (SEASA) Scale, 6 items, score 0 to 60 with higher indicating more coping self-efficacy
Time Frame
3 months post enrollment
Title
Hopelessness
Description
Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness
Time Frame
3 months post enrollment
Title
Reasons for Living
Description
Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live
Time Frame
3 months post enrollment
Title
Anxiety
Description
Brief Symptom Inventory Anxiety Subscale, 6 items, score 0 to 24 with higher indicating more anxiety
Time Frame
3 months post enrollment
Title
Quality of Life (Overall and Health Satisfaction)
Description
WHOQOL-BREF, 2 items, score 2 to 10 with higher indicating better quality of life
Time Frame
3 months post enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon Knettel, Ph.D.
Phone
919-660-1218
Email
brandon.knettel@duke.edu
Facility Information:
Facility Name
Majengo Health Centre
City
Moshi
Country
Tanzania
Individual Site Status
Recruiting
Facility Name
Mawenzi Hospital
City
Moshi
Country
Tanzania
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
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