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

NCT07446764 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-03-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Southern Mississippi

    collaborator OTHER

  • University of Mississippi Medical Center

    collaborator OTHER

  • My Brother's Keeper, Inc.

    lead OTHER

Principal Investigators

  • June A Gipson, PhD · My Brother's Keeper, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-02-01
Primary Completion
2028-04-30
Completion
2028-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07446764 on ClinicalTrials.gov