Trial results for a terminated study investigating a Cognitive Behavioral Therapy (CBT) group intervention for HIV were posted on ClinicalTrials.gov on 2025-08-13, with 289 participants enrolled.
Background
HIV remains a significant global health challenge, with prevention and management strategies continually evolving. Among specific populations, such as Latinx sexual minority men, unique barriers related to intersectional identities, including ethnicity, immigration status, sexual minority identity, and HIV/PrEP status, can impact health outcomes. Stigma associated with these identities can hinder adaptive coping responses, potentially affecting engagement in preventative behaviors like HIV testing and PrEP (Pre-Exposure Prophylaxis) use. Interventions that address these psychosocial factors are crucial for improving HIV outcomes and reducing disparities.
Trial design
This study, which was designated as Phase NA and has since been terminated, enrolled 289 participants. The trial focused on the condition of HIV. The intervention involved a multi-session cognitive behavior therapy (CBT) group designed to improve HIV outcomes by increasing adaptive, effective coping responses to stigma. The study aimed to increase HIV testing and PrEP use among Latinx sexual minority men. No primary outcomes were explicitly listed in the posted results.
Key results
The trial reported several key measurements and analyses:
- HIV Test at Least Annually:
- In the CBT Coping Intervention group, 96 participants reported an HIV test at least annually.
- In the Control group, 114 participants reported an HIV test at least annually.
- Took PrEP in the Past 12 Months:
- In the CBT Coping Intervention group, 56 participants reported taking PrEP in the past 12 months.
- In the Control group, 71 participants reported taking PrEP in the past 12 months.
- Level of Adaptive Coping (scores on a scale, measured at multiple time points):
- CBT Coping Intervention group: mean 2.14 (Standard Deviation 0.96), mean 2.04 (Standard Deviation 0.84), and mean 2.02 (Standard Deviation 0.92).
- Control group: mean 2.05 (Standard Deviation 0.89), mean 2.02 (Standard Deviation 0.91), and mean 1.96 (Standard Deviation 0.92).
Key analyses included:
- One logistic regression analysis reported an Odds Ratio (OR) of 2.51 (95.0% CI: 1.01 to 6.26) with a p-value of 0.049. The specific outcome associated with this analysis was not detailed in the posted results.
- Another logistic regression analysis reported an Odds Ratio (OR) of 1.06 (95.0% CI: 0.62 to 1.81) with a p-value of 0.83.
- A linear regression analysis, which employed a repeated measures style structure for up to 3 follow-up observations, reported a Slope of 0.14 with a p-value of 0.14.
What this means
The termination of this trial indicates that the study did not proceed to its full planned conclusion. While the posted results include measurements for HIV testing, PrEP use, and adaptive coping levels, and one logistic regression analysis showed a statistically significant odds ratio of 2.51 (p=0.049), the specific outcome linked to this significant finding was not detailed. This limitation makes it challenging to draw definitive practical implications for patients. The raw counts for HIV testing and PrEP uptake, along with the adaptive coping scores, provide some data points, but without further context or comparative statistical analyses explicitly linking the intervention to these specific outcomes, the overall impact of the CBT intervention on HIV prevention behaviors and coping mechanisms remains unclear from these results.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04225832, titled "A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men", were posted on 2025-08-13 on clinicaltrials.gov.