Clinic-based HIV Identification and Prevention Project Using Electronic Resources

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinic-based HIV Identification and Prevention Project Using Electronic Resources

Conditions
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HIV Prevention, Primary Care, PrEP

Intervention / Treatment
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* Behavioral: Patient Level
* Behavioral: Multilevel
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Participants in this arm will receive standard of care | Behavioral: Control<br>* Standard of care<br>|
| Experimental: Patient Level + Multilevel<br>Participants in the arm will receive the patient level and multi-level intervention | Behavioral: Patient Level<br>* Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations<br>Behavioral: Multilevel<br>* Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts<br>|
| Experimental: Multilevel<br>Participants in this arm will receive the multi-level intervention | Behavioral: Multilevel<br>* Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts<br>|

What is the study measuring?
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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 | 
| Adoption of Electronic History Form | Proportion of consecutive eligible patients in each clinic who completed the eHxForm. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, HIV prevention, Cis-gender women