Clinic-based HIV Identification and Prevention Project Using Electronic Resources

HIV Prevention Clinical Trial

— CHIPPER  

Official title:

Clinic-based HIV Identification and Prevention Project Using Electronic Resources

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412433
• Other study ID #: IRB00331706
• Secondary ID: 1R01MH132146
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Jenell Coleman, MD MPH
• Phone: 410-614-4496
• Email: colemanj[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1170
• Est. completion date: December 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention
• PrEP
• Primary Care

Intervention

Behavioral:
• Patient Level
Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations
• Multilevel
Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts
• Control
Standard of care

Locations

Country	Name	City	State
United States	Johns Hopkins Health System	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adoption of Electronic History Form	Proportion of consecutive eligible patients in each clinic who completed the eHxForm.	6 months