NCT05412433

Clinic-based HIV Identification and Prevention Project Using Electronic Resources

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,170 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 15 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.

Detailed description

Forty-two Obgyn providers will be randomized into 1 of three arms. Patients of enrolled providers who attend an ObGyn clinic for any preventative visit will complete an electronic history form (eHxForm) before clinic through a message sent through the patient portal (MyChart), email, or secure text messaging. The sexual history questions will be scored and categorized into 3 categories. Patients with a low score (0-3) will receive an electronic message offering a laboratory HIV test per USPSTF guidelines. If she accepts, then an automated Epic order will be placed for the provider to sign during the office visit. Patients with a medium/high score (4-10) will be assigned a study arm based on their provider's group (arm 1: control, arm 2: patient will view score and a PrEP video, arm 3: procedures in arm 2 PLUS providers will receive an electronic health record alert that the patient may have HIV risk factors. This will occur automatically via programming integrated into the electronic health record. The primary outcome is PrEP uptake. The implementation strategy will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Conditions

• HIV Prevention
• Primary Care
• PrEP

Interventions

Type	Name	Description
BEHAVIORAL	Patient Level	Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations
BEHAVIORAL	Multilevel	Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts
BEHAVIORAL	Control	Standard of care

Timeline

• Start date: 2022-10-03
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2022-06-09
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States