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Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

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ClinicalTrials.gov Identifier: NCT04696861
Recruitment Status : Not yet recruiting
First Posted : January 6, 2021
Last Update Posted : January 6, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Kilimanjaro Christian Medical Centre, Tanzania
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Suicide Suicidal Ideation HIV Infections Adherence, Medication Treatment Adherence and Compliance Stigma, Social Disclosure Quality of Life Behavioral: IDEAS for Hope Behavioral: Enhanced Standard of Care (Safety Planning) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Suicide

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.




Primary Outcome Measures :
  1. Suicidal Ideation [ Time Frame: 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 [ Time Frame: 3 months post enrollment ]
    Self-reported clinic attendance

  3. HIV Medication Adherence [ Time Frame: 3 months post enrollment ]
    Self-reported medication adherence


Secondary Outcome Measures :
  1. Depression [ Time Frame: 3 months post enrollment ]
    Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression

  2. HIV Stigma [ Time Frame: 3 months post enrollment ]
    HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma

  3. HIV Acceptance [ Time Frame: 3 months post enrollment ]
    Illness Cognition Questionnaire (ICQ), 6 items, score 0-18 with higher indicating more acceptance

  4. HIV Disclosure [ Time Frame: 3 months post enrollment ]
    Self-reported disclosure to partner, family, friends, others (yes/no) and total number of disclosures

  5. Social Support [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months post enrollment ]
    Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live

  11. Anxiety [ Time Frame: 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) [ Time Frame: 3 months post enrollment ]
    WHOQOL-BREF, 2 items, score 2 to 10 with higher indicating better quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04696861


Contacts
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Contact: Brandon Knettel, Ph.D. 919-660-1218 brandon.knettel@duke.edu

Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Kilimanjaro Christian Medical Centre, Tanzania
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04696861    
Other Study ID Numbers: Pro00107424
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms