SuicideNCT04696861
Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
A study testing IDEAS for Hope in people with Suicide and Suicidal Ideation, run by Duke University at 2 sites in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Suicidal Ideation, HIV Infections
- What is being tested?
- IDEAS for Hope
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTanzania
- Study dates
- 17 May 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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).
Read the 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.
- Conditions
- Suicide, Suicidal Ideation, HIV Infections, Adherence, Medication, Treatment Adherence and Compliance, Stigma, Social
- Being tested
- IDEAS for Hope, Enhanced Standard of Care (Safety Planning)
- Medical subject headings
- Suicide, Suicidal Ideation, HIV Infections, Medication Adherence, Treatment Adherence and Compliance, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDEAS for HopeBehavioural
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)Behavioural
Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Standard of Care (Safety Planning) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months Post Enrollment
Secondary outcomes (10)
Depression
Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression
Measured: 3 months post enrollment
HIV Stigma
HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma
Measured: 3 months post enrollment
Number of HIV Disclosures Made by Participants
Self-reported disclosures to partner, family, friends, others (yes/no)
Measured: 3 months post enrollment
Total Number of HIV Disclosures Made by Participants
Measured: 3 months post enrollment
Social Support
Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support
Measured: 3 months post enrollment
Acceptability of Intervention
10 items adapted from the Client Satisfaction Questionnaire (CSQ), score 10 to 40 with higher indicating greater satisfaction with the intervention
Measured: 3 months post enrollment
Hopelessness
Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness
Measured: 3 months post enrollment
Reasons for Living
Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live
Measured: 3 months post enrollment
Quality of Life (Overall)
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life
Measured: 3 months post enrollment
Quality of Life (Health Satisfaction)
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF), 2 items, score 2 to 10 with higher indicating better quality of life
Measured: 3 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start17 May 2023
- Primary completion8 Dec 2023
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kilimanjaro Christian Medical Centre, Tanzania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696861
- Sponsor's protocol ID
- Pro00107424
- Other IDs
- K08MH124459
- Status last verified
- Sep 2024
- First submitted
- 22 Dec 2020
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madundo K, Mwobobia JM, Perry M, Knippler E, Amiri I, Msoka EF, Tarimo CS, Katiti V, Mmbaga BT, Goldston DB, Relf MV, Knettel BA. HIV and mental health provider experiences of implementing brief depression and suicide screening among people living with HIV in Tanzania: A qualitative study. PLOS Ment Health. 2025 Mar 13;2(3):e0000268. doi: 10.1371/journal.pmen.0000268. eCollection 2025.
PubMed 41661889Knettel 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.
PubMed 40905305
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
- ClinicalTrials.gov ID
- NCT04696861
- Acronym / sponsor ID
- Pro00107424
- Conditions
- Suicide, Suicidal Ideation, HIV Infections, Adherence, Medication, Treatment Adherence and Compliance, Stigma, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kilimanjaro Christian Medical Centre, Tanzania
- Study start
- 17 May 2023 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| IDEAS for Hope Intervention | Experimental | Behavioral: IDEAS for HopeParticipants 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 with Safety Planning | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDEAS for HopeParticipants 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. | Behavioural | IDEAS for Hope Intervention |
| 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. | Behavioural | Enhanced Standard of Care with Safety Planning |
Primary outcome
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.
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.
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.
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.
10 secondary outcomes
Depression
Time frame: 3 months post enrollment
HIV Stigma
Time frame: 3 months post enrollment
Number of HIV Disclosures Made by Participants
Time frame: 3 months post enrollment
Total Number of HIV Disclosures Made by Participants
Time frame: 3 months post enrollment
Social Support
Time frame: 3 months post enrollment
Acceptability of Intervention
Time frame: 3 months post enrollment
Hopelessness
Time frame: 3 months post enrollment
Reasons for Living
Time frame: 3 months post enrollment
Quality of Life (Overall)
Time frame: 3 months post enrollment
Quality of Life (Health Satisfaction)
Time frame: 3 months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41661889Madundo K, Mwobobia JM, Perry M, Knippler E, Amiri I, Msoka EF, Tarimo CS, Katiti V, Mmbaga BT, Goldston DB, Relf MV, Knettel BA. HIV and mental health provider experiences of implementing brief depression and suicide screening among people living with HIV in Tanzania: A qualitative study. PLOS Ment Health. 2025 Mar 13;2(3):e0000268. doi: 10.1371/journal.pmen.0000268. eCollection 2025.
- Derived from this study: PubMed 40905305Knettel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IDEAS for Hope in people with Suicide and Suicidal Ideation, run by Duke University at 2 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Suicidal Ideation (time frame: 3 months post enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04696861, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.