Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04696861
Collaborator
National Institute of Mental Health (NIMH) (NIH), Kilimanjaro Christian Medical Centre, Tanzania (Other)
60
2
26.9

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: IDEAS for Hope
  • Behavioral: Enhanced Standard of Care (Safety Planning)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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).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)
Primary Purpose:
Supportive Care
Official Title:
Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2025
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Suicidal Ideation [3 months post enrollment]

    Columbia-Suicide Severity Rating Scale (C-SSRS), 6 items, scale 0 to 6 with higher indicating more ideation

  2. HIV Care Engagement [3 months post enrollment]

    Self-reported clinic attendance

  3. HIV Medication Adherence [3 months post enrollment]

    Self-reported medication adherence

Secondary Outcome Measures

  1. Depression [3 months post enrollment]

    Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression

  2. HIV Stigma [3 months post enrollment]

    HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma

  3. HIV Acceptance [3 months post enrollment]

    Illness Cognition Questionnaire (ICQ), 6 items, score 0-18 with higher indicating more acceptance

  4. HIV Disclosure [3 months post enrollment]

    Self-reported disclosure to partner, family, friends, others (yes/no) and total number of disclosures

  5. Social Support [3 months post enrollment]

    Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support

  6. Attitudes About Antiretroviral Therapy [3 months post enrollment]

    Beliefs About Medicine Questionnaire (BMQ), 10 items, score 10 to 50 with higher indicating more positive attitudes about medication

  7. 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

  8. Suicide Coping Self-Efficacy [3 months post enrollment]

    Self-Efficacy to Avoid Suicidal Action (SEASA) Scale, 6 items, score 0 to 60 with higher indicating more coping self-efficacy

  9. Hopelessness [3 months post enrollment]

    Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness

  10. 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

  11. Anxiety [3 months post enrollment]

    Brief Symptom Inventory Anxiety Subscale, 6 items, score 0 to 24 with higher indicating more anxiety

  12. Quality of Life (Overall and Health Satisfaction) [3 months post enrollment]

    WHOQOL-BREF, 2 items, score 2 to 10 with higher indicating better quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04696861
Other Study ID Numbers:
  • Pro00107424
First Posted:
Jan 6, 2021
Last Update Posted:
Mar 11, 2022
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022