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NOT YET RECRUITING
NCT07446764
NA

Integrated Health Services (IHS): A Structural Intervention to Improve HIV/STI Screening and PrEP Navigation in Primary Care

Sponsor: My Brother's Keeper, Inc.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether integrating routine, opt-out HIV and STI testing and pre-exposure prophylaxis (PrEP) navigation into primary care increases use of these services among adults ages 18 to 45 receiving care at Federally Qualified Health Centers in Mississippi. The main questions it aims to answer are: 1. Does the integrated model increase HIV and STI testing compared with standard care? 2. Does the integrated model increase PrEP navigation activity for eligible patients? 3. How do patients and clinic staff experience the integrated model in terms of satisfaction, comfort discussing sexual health, and feasibility in daily workflows? Researchers will compare a standard-care period to a period when the integrated model is in place to see if the integrated model improves service use and patient experience. Participants will: 1. Receive usual primary care, with HIV/STI testing and PrEP discussions offered as a routine, opt-out part of care during the integrated period 2. Be invited, if eligible, to complete a brief survey about their clinic experience 3. For staff, be invited to take part in a short survey or interview about clinic workflows and the integrated model

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2027-02-01

Completion Date

2028-07-31

Last Updated

2026-03-03

Healthy Volunteers

Yes

Conditions

Interventions

BEHAVIORAL

Integrated HIV/STI Testing and PrEP Navigation Model

Clinic-level implementation of an integrated sexual and reproductive health model that embeds routine, opt-out HIV and sexually transmitted infection (STI) testing and pre-exposure prophylaxis (PrEP) navigation into primary care at Federally Qualified Health Centers. The intervention includes: (1) standing orders for nurses and peer navigators to initiate HIV/STI testing and PrEP navigation for eligible adults ages 18-45; (2) enhanced electronic health record prompts and templates to support opt-out testing and documentation of offers, completions, and declinations; (3) embedded peer navigation and daily team huddles to coordinate linkage and follow-up; and (4) training and technical assistance for clinic staff on workflows, cultural responsiveness, and stigma-reduction related to sexual health and PrEP.

Locations (1)

My Brother's Keeper, Inc.

Ridgeland, Mississippi, United States