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

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

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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