Federal Register #CDC20261189

CDC Seeks Public Comment on PrEP Adherence Study Using CleverCap and mChoice Tools

The Centers for Disease Control and Prevention (CDC), under the Department of Health and Human Services, is seeking public comment on a proposed research study to improve PrEP (preexposure prophylaxis) uptake and adherence among minority young men who have sex with men (YMSM). - Government Buyer: - Department of Health and Human Services - 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 four clinics in New York, NY, and Birmingham, AL - Enrolls 400 YMSM participants, 30 in-depth interviewees, and 20 healthcare providers - Products/Tools Referenced: - CleverCap medication monitoring devices (for electronic tracking of PrEP adherence) - mChoice mobile application (for adherence support and study interaction) - Services Requested: - Patient enrollment and administration of baseline and quarterly follow-up surveys - Medication adherence monitoring using CleverCap devices and mChoice app - In-depth interviews with 30 YMSM participants - Training and practice facilitation for 20 healthcare providers - Clinic-level assessments every six months at four clinics - Unique/Notable Requirements: - Focus on minority YMSM populations in high-priority urban settings - Integration of electronic medication monitoring and mobile health technology - Emphasis on provider training and clinic practice facilitation to improve PrEP service delivery - Ongoing, multi-year data collection and evaluation - OEMs Highlighted: - CleverCap (medication monitoring device) - mChoice (mobile application) - No specific vendors or resellers are named for procurement; the opportunity is for public comment on the data collection methodology and burden.

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 patient surveys, medication adherence monitoring, provider training, and clinic assessments to improve PrEP clinical services and understand factors influencing PrEP use.

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