Integrated Health Services (IHS): A Structural Intervention to Improve HIV/STI Screening and PrEP… (NCT07446764) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Integrated Health Services (IHS): A Structural Intervention to Improve HIV/STI Screening and PrEP Navigation in Primary Care
United States700 participantsStarted 2027-02-01
Plain-language 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
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HIV Testing Uptake
Timeframe: 12 months during standard-care period and 12 months during integrated-care period