Trial results for a study investigating a web-based cognitive behavioral stress management (CBSM) intervention for Latino sexual minority men living with both HIV and cancer were posted on ClinicalTrials.gov on 2025-06-02. The intervention showed a mean reduction of -10.2 in disease-related distress among the 16 participants.
Background
Individuals living with both HIV and cancer face complex health challenges. For Latino sexual minority men, these diagnoses can be compounded by additional health disparities and elevated levels of distress. Cognitive Behavioral Stress Management (CBSM) interventions are designed to help individuals cope with stress and improve their quality of life. This study aimed to develop and test a culturally-tailored, web-based CBSM intervention specifically for this vulnerable population, addressing their unique needs and experiences.
Trial design
This completed study, designated as Phase NA, enrolled 16 participants. The trial focused on individuals with conditions including HIV/AIDS and Cancer. The intervention involved a culturally-tailored, web-based cognitive behavioral stress management (CBSM) program. The project utilized a single-group pre-post design to assess changes in various stress and quality of life measures over a one-year period.
Key results
The trial reported several key measurements for the culturally-tailored CBSM group:
- Change in General Stress: A mean change of -1.8 (Standard Deviation 10 units on a scale) was observed.
- Change in Disease-Related Distress:
- A mean change of -3.2 (Standard Deviation 6.4 units on a scale).
- A mean change of -5.0 (Standard Deviation 7.2 units on a scale).
- A mean change of -1.9 (Standard Deviation 6.2 units on a scale).
- A mean change of -10.2 (Standard Deviation 17.8 units on a scale).
- Change in Health-Related Quality of Life (FACT-G):
- A mean change of -1.5 (Standard Deviation 8 units on a scale).
- A mean change of 0.2 (Standard Deviation 4.3 units on a scale).
- A mean change of 3.5 (Standard Deviation 3.8 units on a scale).
- A mean change of 0.4 (Standard Deviation 3.9 units on a scale).
- A mean change of 2.7 (Standard Deviation 12.1 units on a scale).
- Change in Health-Related Quality of Life (MOS-HIV):
- A mean change of -1 (Standard Deviation 2.4 units on a scale).
- A mean change of -0.2 (Standard Deviation 4.7 units on a scale).
What this means
The results from this small, single-group pre-post study suggest that a culturally-tailored, web-based cognitive behavioral stress management intervention may help reduce general and disease-related distress in Latino sexual minority men living with HIV and cancer. While some measures of health-related quality of life showed slight improvements, others remained stable or slightly decreased. These preliminary findings are based on a limited number of participants (16) and a non-comparative design, indicating that larger, controlled studies are needed to confirm the efficacy and generalizability of this intervention for this specific population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03993054, titled "Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer", were posted on 2025-06-02 on clinicaltrials.gov.