Clinic-based HIV Identification and Prevention Project Using Electronic Resources

Not Applicable

Recruiting

• Conditions: PrEP; HIV Prevention; Primary Care
• Interventions: Behavioral: Control; Behavioral: Patient Level; Behavioral: Multilevel

• Registration Number: NCT05412433
• Lead Sponsor: Johns Hopkins University

Brief 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.

Study Timeline

• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Study Start: 2022-10-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2027-07-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1170

Inclusion Criteria

• Patients of enrolled providers aged 15-65 years
• Presenting for preventive care (i.e., well-woman exam, sexually transmitted infection testing, pre-conception counseling, or birth control).

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Exclusion Criteria

• Pregnant and has established prenatal care, i.e., visit is for prenatal care
• Non-English or non-Spanish speaking
• Living with HIV
• Unable to complete the eHxForm

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Control	Participants in this arm will receive standard of care
Patient Level + Multilevel	Patient Level	Participants in the arm will receive the patient level and multi-level intervention
Patient Level + Multilevel	Multilevel	Participants in the arm will receive the patient level and multi-level intervention
Multilevel	Multilevel	Participants in this arm will receive the multi-level intervention

Primary Outcome Measures

Name	Time	Method
Number of PrEP prescriptions written for each patient	4 weeks	Number of PrEP prescriptions written for each patient up to 4 weeks after office visit.
Adoption of Electronic History Form	6 months	Proportion of consecutive eligible patients in each clinic who completed the eHxForm.

Trial Locations

Locations (1)

Johns Hopkins Health System; 🇺🇸 Baltimore, Maryland, United States