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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH132146 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Participants in this arm will receive standard of care |
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| Patient Level + Multilevel | Experimental | Participants in the arm will receive the patient level and multi-level intervention |
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| Multilevel | Experimental | Participants in this arm will receive the multi-level intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Level | Behavioral | Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-Effectiveness Analysis (Incremental cost-effectiveness ratios) | Incremental cost-effectiveness ratios | Approximately 5 years |
| Cost-Effectiveness Analysis (Return on Investment) | Return on investment (intervention benefits, avoided direct medical costs, and incremental implementation costs) |
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Inclusion Criteria:
Exclusion Criteria:
Cisgender
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| Name | Affiliation | Role |
|---|---|---|
| Anna Powell, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Health System | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37361343 | Derived | Izadi LH, Mmeje O, Drabo EF, Perin J, Martin S, Coleman JS. An effectiveness-implementation trial protocol to evaluate PrEP initiation among U.S. cisgender women using eHealth tools vs. standard care. Front Reprod Health. 2023 Jun 8;5:1196392. doi: 10.3389/frph.2023.1196392. eCollection 2023. |
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| ID | Term |
|---|---|
| D055361 | Multilevel Analysis |
| ID | Term |
|---|---|
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Multilevel | Behavioral | Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts |
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| Control | Behavioral | Standard of care |
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| Approximately 5 years |
| Cost-Effectiveness Analysis (Total Budget) | Total budget to finance each intervention strategy (intervention and implementation costs) | 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. | 6 months |