Trial results for the 'THRIVE' intervention, addressing Human Immunodeficiency Virus, Depression, and Anxiety, were posted on ClinicalTrials.gov on 2025-10-14, with 75 participants enrolled.
Background
Many individuals living with Human Immunodeficiency Virus (HIV) struggle with consistent engagement in outpatient care. Avoidance, stigma, and denial are significant barriers, impacting health outcomes and hindering efforts to control the HIV epidemic. Co-occurring conditions like Depression and Anxiety further complicate adherence. The 'THRIVE' project aimed to pilot test a new intervention for hospitalized persons out of HIV care who endorse avoidance, seeking to improve outpatient care retention after discharge. This initial study is crucial for developing strategies to enhance HIV care engagement and improve patient health.
Trial design
This completed Phase NA study enrolled 75 participants to investigate an intervention for individuals with Human Immunodeficiency Virus, Depression, and Anxiety. The 'THRIVE' intervention was designed for hospitalized persons out of HIV care who endorse avoidance. Participants were randomized to either the THRIVE intervention group or a 'Treatment as Usual' comparator arm. While specific primary outcome measures were not listed, the trial's objective was to improve engagement in outpatient HIV care after discharge.
Key results
The trial reported several key measurements related to the intervention's acceptability, engagement, and preliminary health indicators:
- Acceptability of Enrollment and Randomization: Eligible But Declined Participation: 0 participants in both the THRIVE and Treatment as Usual groups declined participation.
- Acceptability of Enrollment and Randomization: Completion Sessions: 28 participants in the THRIVE group completed sessions, compared to 0 participants in the Treatment as Usual group.
- Acceptability of the Intervention: 6 Month Follow-up: 21 participants in the THRIVE group completed 6-month follow-up, while 26 participants in the Treatment as Usual group completed follow-up.
- Acceptability of the Intervention (duration): The THRIVE intervention had a duration of 135.5 minutes.
- Viral Load Improvement: 12 participants in the THRIVE group showed viral load improvement, compared to 14 participants in the Treatment as Usual group.
- Number of Patients Who Are Retained in HIV Care: 13 participants in the THRIVE group were retained in HIV care, compared to 16 participants in the Treatment as Usual group.
- Internalized AIDS-Related Stigma Scale (IARSS): The THRIVE group showed a median score of 2 units on a scale.
What this means
The pilot results for the THRIVE intervention indicate high acceptability for enrollment, with no eligible participants declining to join the study. The successful completion of sessions by 28 participants in the THRIVE group, compared to 0 in the Treatment as Usual group, suggests the intervention was successfully delivered as intended. While preliminary data on viral load improvement (12 participants in THRIVE vs. 14 in Treatment as Usual) and retention in HIV care (13 participants in THRIVE vs. 16 in Treatment as Usual) do not show a clear advantage for THRIVE in this initial pilot, these figures provide valuable insights for future larger-scale studies. The median IARSS score of 2 in the THRIVE group offers a baseline for understanding internalized stigma in this population, which is crucial for addressing barriers to care.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04481373, titled 'Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')', were posted on 2025-10-14 on clinicaltrials.gov.