Trial results for a couples-based HIV prevention program were posted on ClinicalTrials.gov on 2025-08-06, with 104 participants enrolled.
Background
HIV remains a significant global health challenge, with prevention efforts being crucial to curb its spread. Interventions targeting specific at-risk populations, such as transgender women and their partners, are vital for effective public health strategies. Addressing HIV risk within the context of relationships can empower individuals and couples to adopt safer practices, thereby reducing new infections and improving overall community health outcomes. This particular trial aimed to evaluate a couples-based approach to HIV prevention.
Trial design
This terminated study, designated as Phase NA, enrolled 104 participants to investigate conditions including HIV Infections and HIV Primary Infection. The trial aimed to test the efficacy of a couples-based HIV prevention program designed to reduce HIV risk among transgender women and their partners. Participants were randomized to either the couples-based HIV prevention intervention or an enhanced standard of care (SOC) control condition and followed quarterly over 12 months.
Key results
The trial reported key measurements related to HIV risk behaviors:
- For 'Condomless Sex':
- The intervention group had 20 participants.
- The control group had 31 participants.
- For 'Composite HIV Risk':
- The intervention group had 17 participants.
- The control group had 28 participants.
What this means
The posted results indicate that the couples-based HIV prevention intervention was associated with fewer participants reporting condomless sex and composite HIV risk compared to the control group. Specifically, 20 participants in the intervention group reported condomless sex versus 31 participants in the control group, and 17 participants in the intervention group had composite HIV risk versus 28 participants in the control group. While these numbers suggest a potential positive direction, the trial was terminated, and no statistical analyses or p-values were provided to confirm the significance of these differences. These preliminary findings may inform future research into couples-based prevention strategies for HIV.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04067661, titled 'A Couples-based Intervention for Transgender Women and Their Partners', were posted on 2025-08-06 on clinicaltrials.gov.