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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05412433
Other study ID # IRB00331706
Secondary ID 1R01MH132146
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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