Trial results for the Supporting Trans Affirmation, Relationships, and Sex (STARS) intervention in HIV prevention were posted on 2025-11-05, indicating that participants in the STARS group achieved a mean Intimate Partner Violence (IPV) frequency score of 0.22, compared to 0.63 in the Relaxation and Stress Reduction control group, at the final reported measurement.
Background
HIV prevention efforts often address multiple interconnected risk factors. For transgender women, these can include gender-based violence and intimate partner victimization (IPV), which are recognized as significant contributors to HIV risk. Interventions that simultaneously address both HIV risk and IPV are crucial for this population. The STARS intervention was developed as a gender-affirming approach to tackle these dual challenges, aiming to improve primary prevention behaviors such as condom use, pre-exposure prophylaxis (PrEP) use, and repeat HIV testing, within the context of IPV and related risk factors like substance use and PTSD.
Trial design
This completed study, identified as Phase NA, enrolled 37 participants. The trial focused on individuals with conditions including HIV, Gender-Based Violence, Domestic Violence, and those engaged in Risk Reduction Behavior. The study evaluated a gender-affirming intervention called Program STARS (Supporting Trans Affirmation, Relationships, and Sex). This intervention was compared against a control group receiving Relaxation and Stress Reduction. The trial aimed to assess whether the intervention could reduce HIV risk within the context of IPV and related factors, and improve primary prevention behaviors.
Key results
The trial reported key measurements for both Composite Risk for HIV (CR-HIV) and Intimate Partner Violence (IPV) Frequency.
- Composite Risk for HIV (CR-HIV):
- For the Program STARS group, the count of participants was reported as 0, 9, and 0 at different measurement points.
- For the Relaxation and Stress Reduction group, the count of participants was reported as 1, 1, and 1 at different measurement points.
- Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale Revised Short Form (CASr-SF):
- For the Program STARS group, mean scores were reported as 2.37 (Standard Deviation 4.27), followed by 1.06 (Standard Deviation 2.93), and finally 0.22 (Standard Deviation 0.65).
- For the Relaxation and Stress Reduction group, mean scores were reported as 1.18 (Standard Deviation 2.38), followed by 0.82 (Standard Deviation 2.09), and finally 0.63 (Standard Deviation 1.62).
What this means
The results from this trial suggest that the Program STARS intervention may have a positive impact on reducing Intimate Partner Violence (IPV) frequency. The observed decrease in the mean IPV frequency score to 0.22 in the STARS group, compared to 0.63 in the control group at the final reported measurement, indicates a potential benefit. Given the established link between IPV and HIV risk, a reduction in IPV could contribute to broader HIV prevention efforts for the target population. While the Composite Risk for HIV data is presented as counts at various points, the IPV frequency scores provide a clearer indication of the intervention's effect on a key risk factor.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06001307, titled "Supporting Trans Affirmation, Relationships, and Sex, Phase 3", were posted on 2025-11-05 on clinicaltrials.gov.