Clinic-based HIV Identification and Prevention Project Using Electronic Resources (CHIPPER)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard of Care
Participants in this arm will receive standard of care
|
Standard of care
|
|
Experimental: Patient Level + Multilevel
Participants in the arm will receive the patient level and multi-level intervention
|
Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations
Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts
|
|
Experimental: Multilevel
Participants in this arm will receive the multi-level intervention
|
Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of PrEP prescriptions written for each patient
Time Frame: 4 weeks
|
Number of PrEP prescriptions written for each patient up to 4 weeks after office visit.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost-Effectiveness Analysis (Incremental cost-effectiveness ratios)
Time Frame: Approximately 5 years
|
Incremental cost-effectiveness ratios
|
Approximately 5 years
|
|
Cost-Effectiveness Analysis (Return on Investment)
Time Frame: Approximately 5 years
|
Return on investment (intervention benefits, avoided direct medical costs, and incremental implementation costs)
|
Approximately 5 years
|
|
Cost-Effectiveness Analysis (Total Budget)
Time Frame: Approximately 5 years
|
Total budget to finance each intervention strategy (intervention and implementation costs)
|
Approximately 5 years
|
|
Proportion of patients who complete the Electronic History Form (eHxForm)
Time Frame: 6 months
|
Adoption of Electronic History Form as assessed by the proportion of consecutive eligible patients in each clinic who completed the eHxForm.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Powell, MD, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00331706
- 1R01MH132146 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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