Trial results for a study investigating PrEP readiness interventions for supporting motivation in individuals with HIV Infections, Pre-exposure Prophylaxis, and Substance Use Disorders were posted on ClinicalTrials.gov on 2025-06-29. The study enrolled a total of 70 participants.
Background
Pre-exposure prophylaxis (PrEP) is a critical tool in HIV prevention, particularly for populations at higher risk. However, uptake and adherence to PrEP can be challenging, especially among individuals with co-occurring conditions such as substance use disorders. This study specifically focused on stimulant-using men who have sex with men (MSM), a group for whom facilitating entry into the PrEP care continuum is vital. The research aimed to explore how contingency management (CM) and motivational interviewing (MI), alone or in combination, could support motivation for PrEP readiness in this specific demographic.
Trial design
This completed study, designated as Phase NA, enrolled 70 participants. The trial investigated interventions for individuals with HIV Infections, Pre-exposure Prophylaxis, and Substance Use Disorders. The overarching goal was to examine the effectiveness of contingency management (CM) and motivational interviewing (MI), individually and combined, in facilitating entry into the PrEP care continuum for stimulant-using men who have sex with men. The study design included groups such as CM-Only, MI-Only, CM+MI, and MI+CM, with further stratification based on responder status or loss to follow-up during an initial stage.
Key results
The trial reported key measurements for the "Proportion of Participants Filling a Prescription for PrEP" across various intervention groups. These measurements appear to represent distinct assessments for each group:
- For the group "CM-Only (Non-Responder or Lost to Follow Up During Stage 1)", 0 participants filled a PrEP prescription in one assessment, and 5 participants in another.
- For the group "MI-Only (Non-Responder or Lost to Follow Up During Stage 1)", 2 participants filled a PrEP prescription in one assessment, and 11 participants in another.
- For the group "CM+MI", 2 participants filled a PrEP prescription in one assessment, and 7 participants in another.
- For the group "MI+CM", 5 participants filled a PrEP prescription in one assessment, and 2 participants in another.
- For the group "CM-Only (Responder)", 11 participants filled a PrEP prescription in one assessment, and 0 participants in another.
- For the group "MI-Only (Responder)", 7 participants filled a PrEP prescription in one assessment, and 0 participants in another.
What this means
The posted results provide specific counts of participants who filled a PrEP prescription across different intervention strategies—contingency management (CM), motivational interviewing (MI), and their combinations—and participant response categories. The varying numbers observed across these groups indicate that the effectiveness in facilitating PrEP uptake may differ depending on the specific intervention approach and whether participants were responders or non-responders/lost to follow-up in an earlier stage. These data contribute to understanding the landscape of PrEP readiness interventions for stimulant-using men who have sex with men, highlighting the complex nature of engagement in PrEP care. Further analysis would be needed to determine the relative efficacy of these interventions.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04205487, titled "PrEP Readiness Interventions for Supporting Motivation", were posted on 2025-06-29 on clinicaltrials.gov.