Federal Register #60Day-26-1428

CDC Research Study on PrEP Adherence Using CleverCap Devices and mChoice App

This opportunity involves a CDC-led research study focused on improving PrEP adherence among minority young men who have sex with men (YMSM): - Government Buyer: - Department of Health and Human Services (HHS) - Centers for Disease Control and Prevention (CDC) - National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention - Study Overview: - 36-month research project titled 'mChoice: Improving PrEP Uptake and Adherence among Minority MSM through Tailored Provider Training and Adherence Assistance in Two High Priority Settings' - Conducted in clinics in New York, NY, and Birmingham, AL - Products/Technologies Mentioned: - CleverCap medication monitoring devices (OEM: CleverCap) - mChoice mobile app (no OEM specified) - Services Requested: - Enrollment and follow-up assessments for 400 YMSM PrEP users - 30 in-depth participant interviews - Training and support for 20 healthcare providers - Clinic-level assessments at four clinics every six months - Unique/Notable Requirements: - Use of electronic medication monitoring (CleverCap) and a custom mobile app (mChoice) for adherence tracking - Focus on tailored provider training and practice facilitation - Emphasis on evidence-based interventions and data collection for both patients and providers - No direct procurement of commercial products or services; the study is primarily a data collection and intervention evaluation effort

Description

The Centers for Disease Control and Prevention (CDC) is seeking public comment on a proposed information collection project titled 'mChoice: Improving PrEP Uptake and Adherence among Minority MSM through Tailored Provider Training and Adherence Assistance in Two High Priority Settings.' This research study aims to implement and evaluate an intervention using evidence-based education and support tools to improve preexposure prophylaxis (PrEP) adherence among young men who have sex with men (YMSM). The study will be conducted in four clinics located in New York, NY, and Birmingham, AL, enrolling 400 YMSM participants and 20 healthcare providers over a 36-month period. The project includes surveys, interviews, provider training, and clinic assessments to evaluate the effectiveness of the intervention and understand factors influencing PrEP adherence and choices.

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