Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

HIV Infections Clinical Trial

Official title:

Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

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
• 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
• 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

Related Conditions & MeSH terms

• Adherence, Medication
• Disclosure
• HIV Infections
• Quality of Life
• Stigma, Social
• Suicidal Ideation
• Suicide
• Treatment Adherence and Compliance

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