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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04696861
Other study ID # Pro00107424
Secondary ID K08MH124459
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 17, 2023
Est. completion date March 31, 2025

Study information

Verified date December 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date March 31, 2025
Est. primary completion date December 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Tanzania Majengo Health Centre Moshi
Tanzania Mawenzi Hospital Moshi

Sponsors (3)

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

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Suicidal Ideation Columbia-Suicide Severity Rating Scale (C-SSRS), 6 items, scale 0 to 6 with higher indicating more ideation 3 months post enrollment
Primary HIV Care Engagement Self-reported clinic attendance 3 months post enrollment
Primary HIV Medication Adherence Self-reported medication adherence 3 months post enrollment
Secondary Depression Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression 3 months post enrollment
Secondary HIV Stigma HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma 3 months post enrollment
Secondary HIV Acceptance Illness Cognition Questionnaire (ICQ), 6 items, score 0-18 with higher indicating more acceptance 3 months post enrollment
Secondary HIV Disclosure Self-reported disclosure to partner, family, friends, others (yes/no) and total number of disclosures 3 months post enrollment
Secondary Social Support Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support 3 months post enrollment
Secondary Attitudes About Antiretroviral Therapy Beliefs About Medicine Questionnaire (BMQ), 10 items, score 10 to 50 with higher indicating more positive attitudes about medication 3 months post enrollment
Secondary 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
Secondary 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 3 months post enrollment
Secondary Hopelessness Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness 3 months post enrollment
Secondary 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
Secondary Anxiety Brief Symptom Inventory Anxiety Subscale, 6 items, score 0 to 24 with higher indicating more anxiety 3 months post enrollment
Secondary Quality of Life (Overall and Health Satisfaction) WHOQOL-BREF, 2 items, score 2 to 10 with higher indicating better quality of life 3 months post enrollment
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