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: Active, not 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 Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Health System

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-Effectiveness Analysis (Incremental cost-effectiveness ratios)	Incremental cost-effectiveness ratios	Approximately 5 years
Cost-Effectiveness Analysis (Return on Investment)	Return on investment (intervention benefits, avoided direct medical costs, and incremental implementation costs)	Approximately 5 years
Cost-Effectiveness Analysis (Total Budget)	Total budget to finance each intervention strategy (intervention and implementation costs)	Approximately 5 years
Proportion of patients who complete the Electronic History Form (eHxForm)	Adoption of Electronic History Form as assessed by the 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: Anna Powell, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Izadi LH, Mmeje O, Drabo EF, Perin J, Martin S, Coleman JS. An effectiveness-implementation trial protocol to evaluate PrEP initiation among U.S. cisgender women using eHealth tools vs. standard care. Front Reprod Health. 2023 Jun 8;5:1196392. doi: 10.3389/frph.2023.1196392. eCollection 2023.

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 (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: PrEP; HIV prevention; Cis-gender women
• Additional Relevant MeSH Terms: Epidemiologic Methods; Public Health; Environment and Public Health; Statistics as Topic; Multilevel Analysis
• 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