N/A
N=60
Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania
Suicide · Suicidal Ideation · HIV Infections · Adherence, Medication · Treatment Adherence and Compliance
Bottom Line
View on ClinicalTrials.gov: NCT04696861 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Suicidal Ideation — 4; 3; 0; 0 Participants — p=0.961
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IDEAS for Hope (Behavioral); Enhanced Standard of Care (Safety Planning) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Suicidal Ideation |
4; 3; 0; 0; 0; 0 | 0.961 |
| PRIMARY Number of Participants With a Gap in HIV Care Engagement |
2; 1 | 0.961 |
| PRIMARY HIV Medication Adherence, as Measured by Number of Participants Who Report Adherence Challenges |
1; 2 | 0.368 |
| PRIMARY Viral Load |
— | — |
| SECONDARY Depression |
2.71; 3.13 | 0.634 |
| SECONDARY HIV Stigma |
29.35; 30.31 | 0.832 |
| SECONDARY Number of HIV Disclosures Made by Participants |
2; 1; 0; 2; 4; 2 | — |
| SECONDARY Total Number of HIV Disclosures Made by Participants |
6; 7 | 0.624 |
| SECONDARY Social Support |
27.21; 27.9 | 0.833 |
| SECONDARY Acceptability of Intervention |
34.93; 33.5 | 0.7 |
| SECONDARY Hopelessness |
1.75; 2.4 | 0.79 |
| SECONDARY Reasons for Living |
60.54; 62.3 | 0.55 |
| SECONDARY Quality of Life (Overall) |
3.54; 3.60 | .823 |
| SECONDARY Quality of Life (Health Satisfaction) |
3.79; 3.73 | .942 |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04696861). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.