NCT04696861

Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania

Completed NA Results posted Last updated 20 April 2025

What this trial tests

NA trial testing IDEAS for Hope in Suicide in 60 participants. Completed in 31 March 2025.

Timeline

17 May 2023

Primary endpoint
8 December 2023

31 March 2025

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	17 May 2023
Primary completion	8 December 2023
Estimated completion	31 March 2025
Sites	2 locations across Tanzania

Drugs / interventions tested

• IDEAS for Hope
• Enhanced Standard of Care (Safety Planning)

Conditions studied

• Suicide — all drugs for Suicide →
• Suicidal Ideation — all drugs for Suicidal Ideation →
• HIV Infections — all drugs for HIV Infections →
• Adherence, Medication — all drugs for Adherence, Medication →

Sponsor

Duke University

Who can join

18 and older, any sex, with Suicide or Suicidal Ideation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Suicidal Ideation Primary · 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.

Suicidal Thoughts

Group	Value	95% CI
IDEAS for Hope Intervention	4
Enhanced Standard of Care With Safety Planning	3

Plan

Group	Value	95% CI
IDEAS for Hope Intervention	0
Enhanced Standard of Care With Safety Planning	0

Intent

Group	Value	95% CI
IDEAS for Hope Intervention	0
Enhanced Standard of Care With Safety Planning	0

Number of Participants With a Gap in HIV Care Engagement Primary · 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.

Group	Value	95% CI
IDEAS for Hope Intervention	2
Enhanced Standard of Care With Safety Planning	1

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

Group	Value	95% CI
IDEAS for Hope Intervention	1
Enhanced Standard of Care With Safety Planning	2

Depression Secondary · 3 months post enrollment

Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression

Group	Value	95% CI
IDEAS for Hope Intervention	2.71	± 2.43
Enhanced Standard of Care With Safety Planning	3.13	± 2.87

HIV Stigma Secondary · 3 months post enrollment

HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma

Group	Value	95% CI
IDEAS for Hope Intervention	29.35	± 3.49
Enhanced Standard of Care With Safety Planning	30.31	± 5.39

Number of HIV Disclosures Made by Participants Secondary · 3 months post enrollment

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

Disclosed to partner

Group	Value	95% CI
IDEAS for Hope Intervention	2
Enhanced Standard of Care With Safety Planning	1

Disclosed to family

Group	Value	95% CI
IDEAS for Hope Intervention	0
Enhanced Standard of Care With Safety Planning	2

Disclosed to friends

Group	Value	95% CI
IDEAS for Hope Intervention	4
Enhanced Standard of Care With Safety Planning	2

Disclosed to others

Group	Value	95% CI
IDEAS for Hope Intervention	0
Enhanced Standard of Care With Safety Planning	2

Total Number of HIV Disclosures Made by Participants Secondary · 3 months post enrollment

Group	Value	95% CI
IDEAS for Hope Intervention	6
Enhanced Standard of Care With Safety Planning	7

Social Support Secondary · 3 months post enrollment

Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support

Group	Value	95% CI
IDEAS for Hope Intervention	27.21	± 7.15
Enhanced Standard of Care With Safety Planning	27.9	± 7.42

Acceptability of Intervention Secondary · 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

Group	Value	95% CI
IDEAS for Hope Intervention	34.93	± 3.11
Enhanced Standard of Care With Safety Planning	33.5	± 2.78

Hopelessness Secondary · 3 months post enrollment

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

Group	Value	95% CI
IDEAS for Hope Intervention	1.75	± 2.12
Enhanced Standard of Care With Safety Planning	2.4	± 2.33

Reasons for Living Secondary · 3 months post enrollment

Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live

Group	Value	95% CI
IDEAS for Hope Intervention	60.54	± 8.79
Enhanced Standard of Care With Safety Planning	62.3	± 5.49

Quality of Life (Overall) Secondary · 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

Group	Value	95% CI
IDEAS for Hope Intervention	3.54	± 0.84
Enhanced Standard of Care With Safety Planning	3.60	± 0.62

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months post enrollment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IDEAS for Hope Intervention

Serious: 1/30 (3%)

Deaths: 1/30

Enhanced Standard of Care With Safety Planning

Serious: 0/30 (0%)

Deaths: 0/30

Serious adverse events (1 terms)

Reaction	System	IDEAS for Hope Intervention	Enhanced Standard of Care …
AIDS-related complications	Immune system disorders	—	—

Most-reported serious reactions: AIDS-related complications.

Data from ClinicalTrials.gov NCT04696861 adverse events section.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient experiences and contextual appropriateness of universal screening for depression and suicide risk in HIV care: a qualitative study in Tanzania.
   Madundo K, Perry M, Mwobobia J, Shekibula I, et al · · 2025 · cited 1× · PMID 40343235 · DOI 10.3389/frhs.2025.1557348
2. HIV and mental health provider experiences of implementing brief depression and suicide screening among people living with HIV in Tanzania: A qualitative study.
   Madundo K, Mwobobia JM, Perry M, Knippler E, et al · · 2025 · PMID 41661889 · DOI 10.1371/journal.pmen.0000268
3. Results of a Pilot Randomized Controlled Trial of IDEAS for Hope: A Brief Telehealth Intervention for Suicide Prevention and HIV Care Engagement in Tanzania.
   Knettel BA, Madundo K, Amiri I, Msoka EF, et al · · 2025 · PMID 40905305 · DOI 10.1097/qai.0000000000003758