Clinic-based HIV Identification and Prevention Project Using Electronic Resources (CHIPPER)

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.

Study Overview

• Status: Recruiting
• Conditions: PrEP; HIV Prevention; Primary Care
• Intervention / Treatment: Behavioral: Control; Behavioral: Patient Level; Behavioral: Multilevel

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 Type: Interventional
• Enrollment (Estimated): 1170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenell Coleman, MD MPH; Phone Number: 410-614-4496; Email: colemanj@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Health System
      • Contact: Jenell Coleman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Participants in this arm will receive standard of care	Behavioral: Control; Standard of care
Experimental: Patient Level + Multilevel; Participants in the arm will receive the patient level and multi-level intervention	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
Experimental: Multilevel; Participants in this arm will receive the multi-level intervention	Behavioral: Multilevel; Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Mental Health (NIMH); University of Michigan
• Investigators: Principal Investigator: Jenell Coleman, MD MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: PrEP; HIV prevention; Cis-gender women
• Other Study ID Numbers: IRB00331706; 1R01MH132146 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No