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

Johns Hopkins University logo

Johns Hopkins University

Status

Enrolling

Conditions

HIV Prevention
Primary Care
PrEP

Treatments

Behavioral: Multilevel
Behavioral: Control
Behavioral: Patient Level

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05412433
IRB00331706
1R01MH132146 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,170 estimated patients

Sex

Female

Ages

15 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

1,170 participants in 3 patient groups

Standard of Care
Active Comparator group
Description:
Participants in this arm will receive standard of care
Treatment:
Behavioral: Control
Patient Level + Multilevel
Experimental group
Description:
Participants in the arm will receive the patient level and multi-level intervention
Treatment:
Behavioral: Patient Level
Behavioral: Multilevel
Multilevel
Experimental group
Description:
Participants in this arm will receive the multi-level intervention
Treatment:
Behavioral: Multilevel

Trial contacts and locations

1

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Central trial contact

Jenell Coleman, MD MPH

Data sourced from clinicaltrials.gov

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