Integrated Health Services (IHS): A Structural Intervention to Improve HIV/STI Screening and PrEP Navigation in Primary Care
IHS
2 other identifiers
interventional
700
1 country
1
Brief 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?
- 4.Receive usual primary care, with HIV/STI testing and PrEP discussions offered as a routine, opt-out part of care during the integrated period
- 5.Be invited, if eligible, to complete a brief survey about their clinic experience
- 6.For staff, be invited to take part in a short survey or interview about clinic workflows and the integrated model
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Feb 2027
Shorter than P25 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedStudy Start
First participant enrolled
February 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
Study Completion
Last participant's last visit for all outcomes
July 31, 2028
March 3, 2026
February 1, 2026
1.2 years
February 10, 2026
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HIV Testing Uptake
Proportion of primary care visits among adults ages 18-45 at participating FQHC clinics with an HIV test completed (numerator: visits with HIV test completed; denominator: eligible visits for adults 18-45), comparing the standard-care period to the integrated-care period using electronic health record data.
12 months during standard-care period and 12 months during integrated-care period
Secondary Outcomes (5)
STI Testing Uptake
12 months during standard-care period and 12 months during integrated-care period
PrEP Navigation Activity
12 months during standard-care period and 12 months during integrated-care period
Patient Satisfaction With Integrated Care
Within 7 days of an index primary care visit during the integrated-care period
Staff Feasibility Rating
At 6 and 12 months after initiation of the integrated-care period
Staff Acceptability Rating
Assessed at 6 months and 12 months after initiation of the integrated care period.
Study Arms (2)
Standard Care
NO INTERVENTIONUsual care delivered before implementation of the Integrated Health Services (IHS) model. HIV/STI testing and PrEP navigation occur at provider discretion without standardized workflows or EHR prompts. This represents the 12-month pre-intervention period.
Integrated HIV/STI and PrEP Care
EXPERIMENTALCare delivered during the 12-month intervention period using the Integrated Health Services (IHS) model, which incorporates routine opt-out HIV/STI screening, standing orders, EHR prompts, and standardized PrEP navigation workflows
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adults ages 18 to 45 years.
- Receiving primary care services at participating Federally Qualified Health Center (FQHC) clinics in Canton or Yazoo City, Mississippi.
- Able to understand and read English (for participation in surveys and interviews).
- For staff key informants: current clinical, administrative, or support role at a participating FQHC site with responsibilities related to primary care, HIV/STI services, or care coordination.
You may not qualify if:
- Younger than 18 years or older than 45 years.
- Critically ill, psychiatrically unstable, or lacking capacity to provide informed consent for research participation.
- Unable to understand English for consent and survey/interview procedures.
- For staff key informants: unable or unwilling to provide informed consent for interviews or surveys.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Mississippicollaborator
- University of Mississippi Medical Centercollaborator
- My Brother's Keeper, Inc.lead
Study Sites (1)
My Brother's Keeper, Inc.
Ridgeland, Mississippi, 39157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
June A Gipson, PhD
My Brother's Keeper, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 10, 2026
First Posted
March 3, 2026
Study Start (Estimated)
February 1, 2027
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
March 3, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- De-identified IPD and supporting documents will be available beginning within 12 months after publication of the primary study results in a peer-reviewed journal or submission of the main results to ClinicalTrials.gov, whichever occurs first. Data will remain available for at least 5 years after initial release, or longer if required by funder or institutional policies. Requests received after that period may be considered on a case-by-case basis depending on data retention and feasibility.
- Access Criteria
- De-identified IPD will be shared with qualified researchers at academic, clinical, or public health institutions for analyses that are consistent with the original study aims (for example, secondary implementation, health services, or equity-focused analyses) or address clearly justified, related scientific questions. Requestors must submit a brief research proposal, analysis plan, and evidence of IRB/ethics approval or exemption. Requests will be reviewed by the Principal Investigator and designated study leadership at My Brother's Keeper, Inc. and collaborating institutions to assess scientific merit, feasibility, and consistency with participant privacy protections and data-use agreements. Approved requestors will sign a data-use agreement that prohibits any attempt at re-identification and limits data use to the approved project. Data will be provided via secure, encrypted transfer or a controlled-access data repository.
De-identified individual participant data (IPD) that underlie the primary and secondary outcome results (selected EHR variables for adults ages 18-45 and de-identified patient and staff survey responses) will be shared. No direct identifiers or HIPAA-defined identifiers will be included, and small cells will be handled to reduce re-identification risk. IPD will be available within 12 months after publication of the main study findings and for at least 5 years thereafter. Data will be shared with qualified researchers who have a scientifically sound proposal, appropriate ethics/IRB approval, and a signed data use agreement with My Brother's Keeper, Inc. and partner clinics. Data will be provided via secure, encrypted transfer or a controlled-access repository.