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

Conditions

• HIV
• STDs

Eligibility Criteria

Sex

ALL

Age

18 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• Integrated HIV/STI Testing and PrEP Navigation Model — BEHAVIORAL
  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.

Study Details

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 Dates

Start date

Feb 1, 2027

Status verified

Feb 2026

Primary completion

Apr 30, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

700 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• No Intervention: Standard Care
  Usual 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.
• Experimental: Integrated HIV/STI and PrEP Care
  Care 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

Primary Outcome Measure

HIV Testing Uptake [ Time Frame: 12 months during standard-care period and 12 months during integrated-care period ]

Central Contacts

• June A Gipson, PhD
  769-216-2455
  [email protected]
• Edna S Lampkin, Pharm D.
  769-216-2455
  [email protected]

Locations (1)

Find similar trials in Ridgeland, MS

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