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Completed

NCT Number: NCT04696861

Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

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).

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Key information

Conditions

Suicide Adherence, Medication Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Disclosure Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Patient Acceptance of Health Care Patient Compliance Quality of Life RNA Virus Infections Retroviridae Infections Self-Injurious Behavior Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Social Behavior Social Stigma Stigma, Social Suicidal Ideation Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Majengo Health Centre, Moshi, Tanzania

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants With Suicidal Ideation

    Time frame: 3 months post enrollment

    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.

  2. Number of Participants With a Gap in HIV Care Engagement

    Time frame: 3 months post enrollment

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

    Time frame: 3 months post enrollment

    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.

  4. Viral Load

    Time frame: Baseline, 3 months Post Enrollment

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

Secondary outcomes

  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. Number of HIV Disclosures Made by Participants

    Time frame: 3 months post enrollment

    Self-reported disclosures to partner, family, friends, others (yes/no)

  4. Total Number of HIV Disclosures Made by Participants

    Time frame: 3 months post enrollment

  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. 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

  7. Hopelessness

    Time frame: 3 months post enrollment

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

  8. 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

  9. Quality of Life (Overall)

    Time frame: 3 months post enrollment

    The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life

  10. Quality of Life (Health Satisfaction)

    Time frame: 3 months post enrollment

    The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Jan 6, 2021
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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