HIV Prevention, PrEP, Primary Care
Conditions
Keywords
HIV prevention, PrEP, Cis-gender women
Brief 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.
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.
Interventions
BEHAVIORALPatient Level
Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations
BEHAVIORALMultilevel
Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts
BEHAVIORALControl
Standard of care
Sponsors
Johns Hopkins University
University of Michigan
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of PrEP prescriptions written for each patient | 4 weeks | Number of PrEP prescriptions written for each patient up to 4 weeks after office visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-Effectiveness Analysis (Incremental cost-effectiveness ratios) | Approximately 5 years | Incremental cost-effectiveness ratios |
| Cost-Effectiveness Analysis (Return on Investment) | Approximately 5 years | Return on investment (intervention benefits, avoided direct medical costs, and incremental implementation costs) |
| Cost-Effectiveness Analysis (Total Budget) | Approximately 5 years | Total budget to finance each intervention strategy (intervention and implementation costs) |
| Proportion of patients who complete the Electronic History Form (eHxForm) | 6 months | Adoption of Electronic History Form as assessed by the proportion of consecutive eligible patients in each clinic who completed the eHxForm. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnna Powell, MD
Johns Hopkins University
Outcome results
None listed