Clinic-based HIV Identification and Prevention Project Using Electronic Resources

N/AActive Not RecruitingNCT05412433

Johns Hopkins University1,170 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

1,170

Conditions

HIV Prevention Primary Care PrEP

Interventions

Patient LevelBEHAVIORAL

Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations

MultilevelBEHAVIORAL

Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts

ControlBEHAVIORAL

Standard of care

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins Health System

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Number of PrEP prescriptions written for each patient

Number of PrEP prescriptions written for each patient up to 4 weeks after office visit.

Time frame: 4 weeks

Secondary Outcomes

Cost-Effectiveness Analysis (Incremental cost-effectiveness ratios)

Incremental cost-effectiveness ratios

Time frame: Approximately 5 years

Cost-Effectiveness Analysis (Return on Investment)

Return on investment (intervention benefits, avoided direct medical costs, and incremental implementation costs)

Time frame: Approximately 5 years

Cost-Effectiveness Analysis (Total Budget)

Total budget to finance each intervention strategy (intervention and implementation costs)

Time frame: Approximately 5 years

Proportion of patients who complete the Electronic History Form (eHxForm)

Adoption of Electronic History Form as assessed by the proportion of consecutive eligible patients in each clinic who completed the eHxForm.

Time frame: 6 months

Data from ClinicalTrials.gov

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