Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

NCT04696861 | Completed Results

• 2 other identifiers: Pro00107424K08MH124459
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Suicidal Ideation

  Columbia-Suicide Severity Rating Scale (C-SSRS) items measuring suicidal thoughts (yes/no), intent (yes/no), and plan (yes/no). Reported here are the number of participants who responded 'yes' to each of the items.

  3 months post enrollment

• Number of Participants With a Gap in HIV Care Engagement

  Participant medical records were reviewed after the 3-month follow-up survey to identify whether they had a gap in care during the study period, defined as 6 or more days where they did not have enough prescribed medication on hand to maintain adherence between HIV clinic appointments.

  3 months post enrollment

• HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges

  During the baseline and follow-up surveys, participants were asked two questions related to their adherence to antiretroviral medication: "Think about the last 14 days. On how many days did you miss taking your HIV pill(s)?" and the same question with a 90 day recall period. Adherence challenges were coded yes/no at each time point, defined as (1) missing 3 or more days of medication in the past 14 days or (2) missing 6 or more days in the past 90 days.

  3 months post enrollment

• Viral Load

  Extraction of routine HIV viral load testing from the patient medical record at baseline and 3-months post study enrollment.

  Baseline, 3 months Post Enrollment

Secondary Outcomes (10)

• Depression

  3 months post enrollment

• HIV Stigma

  3 months post enrollment

• Number of HIV Disclosures Made by Participants

  3 months post enrollment

• Total Number of HIV Disclosures Made by Participants

  3 months post enrollment

• Social Support

  3 months post enrollment

Study Arms (2)

IDEAS for Hope Intervention

EXPERIMENTAL

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

Enhanced Standard of Care with Safety Planning

ACTIVE COMPARATOR

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)

Interventions

IDEAS for Hope BEHAVIORAL

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.

IDEAS for Hope Intervention

Enhanced Standard of Care (Safety Planning) BEHAVIORAL

Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.

Enhanced Standard of Care with Safety Planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Majengo Health Centre

Moshi, Tanzania

Location

Mawenzi Hospital

Moshi, Tanzania

Location

Related Publications (1)

• Knettel BA, Madundo K, Amiri I, Msoka EF, Pan W, Khofi T, Ngangula P, Turner EL, Joel L, Rwakilomba J, Tarimo CS, Katiti V, Knippler ET, Mmbaga BT, Relf MV, Goldston DB. Results of a Pilot Randomized Controlled Trial of IDEAS for Hope: A Brief Telehealth Intervention for Suicide Prevention and HIV Care Engagement in Tanzania. J Acquir Immune Defic Syndr. 2025 Dec 15;100(5):435-444. doi: 10.1097/QAI.0000000000003758.

  PMID: 40905305 DERIVED

MeSH Terms

Conditions

Suicide; Suicidal Ideation; HIV Infections; Medication Adherence; Treatment Adherence and Compliance; Social Stigma

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Health Behavior; Social Behavior

Results Point of Contact

• Title: Brandon Knettel
• Organization: Duke University School of Nursing

brandon.knettel@duke.edu

1 919 660 1218

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 6, 2021
• Study Start: May 17, 2023
• Primary Completion: December 8, 2023
• Study Completion: March 31, 2025
• Last Updated: April 20, 2025
• Results First Posted: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TA (2)