Trial results for a study investigating a trauma-focused intervention for older adults living with HIV were posted on ClinicalTrials.gov on 2025-07-31, involving 28 participants.
Background
HIV is a chronic condition requiring lifelong antiretroviral therapy (ART) for management. Adherence to ART is critical for viral suppression, preventing disease progression, and reducing transmission. As the population of people living with HIV ages, they face unique challenges, including the cumulative effects of the virus, comorbidities, and psychosocial factors. A significant proportion of individuals with HIV have a history of trauma, which can complicate disease management, impact mental health, and affect ART adherence. Addressing trauma in this population, particularly among older adults exposed to childhood sexual abuse, is an important area for intervention development to improve overall health outcomes and quality of life.
Trial design
This completed study, designated as Phase NA, enrolled 28 participants. The trial investigated conditions including Trauma, Hiv, and Aging. Investigators aimed to adapt the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse. The study compared an intervention group against a control group.
Key results
The trial reported several key measurements related to ART adherence and health-related quality of life:
- ART Adherence (score on a scale):
- In the Intervention group, a mean score of 79.0 (Standard Deviation 25.9) was observed.
- In the Control group, a mean score of 92.7 (Standard Deviation 2.5) was observed.
- Another measurement in the Intervention group showed a mean score of 92.4 (Standard Deviation 11.3).
- Another measurement in the Control group showed a mean score of 96.4 (Standard Deviation 4.8).
- A further measurement in the Intervention group showed a mean score of 79.1 (Standard Deviation 29.1).
- A further measurement in the Control group showed a mean score of 96.3 (Standard Deviation 4.3).
- Yet another measurement in the Intervention group showed a mean score of 83.7 (Standard Deviation 22.0).
- Yet another measurement in the Control group showed a mean score of 91.1 (Standard Deviation 22.6).
- Health-related Quality of Life - General Health (score on a scale):
- In the Intervention group, a mean score of 2.59 (Standard Deviation 0.80) was observed.
- In the Control group, a mean score of 2.36 (Standard Deviation 1.21) was observed.
- Another measurement in the Intervention group showed a mean score of 2.64 (Standard Deviation 1.08).
- Another measurement in the Control group showed a mean score of 3.50 (Standard Deviation 1.05).
An ANOVA analysis reported a p-value of 0.061.
What this means
The posted results provide data on ART adherence and health-related quality of life for older adults with HIV participating in a trauma-focused intervention. While the ANOVA analysis yielded a p-value of 0.061, suggesting a trend, it did not reach conventional statistical significance. The various measurements for ART adherence show mixed outcomes, with some intervention group scores lower than control, while quality of life scores also varied. These findings indicate the complexity of addressing trauma in this population and highlight the need for further research to refine interventions and confirm efficacy.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05287230, titled "Developing a Trauma-focused Intervention for Older Adults Living With HIV", were posted on 2025-07-31 on clinicaltrials.gov.