Trial results for a study on HIV prevention strategies were posted on ClinicalTrials.gov on 2025-11-03, involving 71 participants.
Background
HIV infections remain a significant public health concern, particularly among adolescents and young adults. Effective prevention strategies often involve comprehensive HIV testing and counseling, alongside interventions that enhance communication skills related to sexual health and safety. This study aimed to compare different methods of delivering a couples HIV Testing and Counseling (CHTC) intervention, designed to be suitable for young populations, to improve sexual safety and reduce HIV transmission risk behaviors.
Trial design
This completed study, designated as Phase NA, enrolled 71 participants. The trial investigated conditions including HIV/AIDS and HIV Infections. The study compared different approaches to delivering a couples HIV Testing and Counseling (CHTC) intervention. The arms included "We Test - Index Participants", "Individual HIV Testing and Counseling - Index Participants", and "Individual Counseling and Testing - Partner Participants".
Key results
The trial reported several key measurements related to HIV transmission risk behavior and communication skills:
- HIV Transmission Risk Behavior (Count of Participants):
- For "We Test - Index Participants", counts were 9, 4, and 4 participants.
- For "Individual HIV Testing and Counseling - Index Participants", counts were 11, 8, and 6 participants.
- For "Individual Counseling and Testing - Partner Participants", counts were 0, 0, and 0 participants.
- Communication Skills (Units on a scale):
- For "We Test - Index Participants", the mean score was 123 (Standard Deviation 11.01).
- For "Individual HIV Testing and Counseling - Index Participants", the mean score was 121.19 (Standard Deviation 12.78).
- For "Individual Counseling and Testing - Partner Participants", the mean score was 129.00.
Key analyses included:
- A Negative Binomial Regression analysis, comparing participants in the "We Test - Index" and "Individual HIV Testing and Counseling - Index" arms, yielded a Chi Square of 1.36 with a p-value of 0.2. This analysis only included participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.
- Another Negative Binomial Regression analysis for the same groups showed a Chi Square of 0.03 with a p-value of 0.58. This analysis only included participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.
- A 2-sided t-test comparing mean differences in final values between the "We Test - Index" and "Individual HIV Testing and Counseling - Index" arms resulted in a mean difference of -1.82 with a p-value of 0.08. This analysis only included participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.
- Another 2-sided t-test for mean differences in final values between the "We Test - Index" and "Individual HIV Testing and Counseling - Index" arms showed a mean difference of -2.5 with a p-value of 0.02. This analysis only included participants who participated in the We Test - Index arm and Individual HIV Testing and Counseling - Index arm on their own.
What this means
The results from this study provide insights into the comparative effectiveness of different HIV testing and counseling delivery methods on communication skills and HIV transmission risk behaviors. While counts for risk behaviors were reported across groups, a statistically significant difference was observed in communication skills between the "We Test - Index" and "Individual HIV Testing and Counseling - Index" arms, with a mean difference of -2.5 and a p-value of 0.02. This suggests that the specific intervention approaches may have varying impacts on participants' ability to communicate, a critical factor in promoting sexual safety and reducing HIV transmission.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04289116, titled "Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM", were posted on 2025-11-03 on clinicaltrials.gov.