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| Name | Class |
|---|---|
| San Francisco Department of Public Health | OTHER_GOV |
| Alto Pharmacy | UNKNOWN |
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The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.
The investigators will be testing a pharmacist-led model of PrEP delivery combined with mobile app-based PrEP support developed by the investigator's team to improve PrEP initiation and persistence. Alto Pharmacy is a full-service online pharmacy already using mobile and web apps to communicate with patients, providers, laboratories, and insurers to provide timely medication delivery. Alto can provide PrEP prescriptions, order laboratory tests, and perform clinical referrals through a collaborative practice agreement (CPA) with SFDPH that allows transfer of these responsibilities. The investigators have integrated online tools with Alto Pharmacy's technology platform to create PrEP-3D: Digital Diary and Delivery, combining a tailored online support tool with the personalized service of a community pharmacy and the convenience of medication delivery. By removing the requirement for initiation and quarterly visits with a primary care physician for PrEP, the PrEP-3D model will expand access to PrEP visits (including for persons who choose not to go to their primary care provider for PrEP) and reduce burden on the health care system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP-3D | Experimental | Use of Alto Pharmacy, PrEP-3D mobile app and home laboratory testing. |
|
| Control Arm | Other | Participants in the control arm will receive standard of care PREP navigation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP-3D package | Behavioral | A package of support tools for accessing, adhering to, and monitoring PrEP use, including Alto Pharmacy delivery services, PrEP-3D mobile app, and home laboratory testing. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of PREP-3D on PREP use | Measurement of PrEP adherence using dried blood spot measurements of tenofovir-diphosphate (TFV-DP) levels greater than or equal to 700 fmol/punch | 12 months |
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Inclusion Criteria:
Age 18 years or older
Assigned male at birth who reports sex with persons assigned male at birth
Willing and able to provide written informed consent
HIV-uninfected by negative 4th generation HIV test during screening
Owns a smartphone and has private access to the internet
Able to understand, read, and speak English or Spanish
Lives in California
Self-reported evidence of being at-risk for HIV acquisition, including at least one of the following in the past 6 months:
Interested in taking daily TDF/FTC or TAF/FTC PrEP
Willing and able to receive PrEP prescriptions through Alto Pharmacy (e.g., no specific pharmacy required by health plan, such as Kaiser HMO)
Creatinine clearance >30 mL/min
No contraindications to TDF/FTC or TAF/FTC use
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Coleman, MA | Contact | 628-217-7443 | kenneth.coleman@sfdph.org |
| Name | Affiliation | Role |
|---|---|---|
| Susan Buchbinder, MD | Bridge HIV, San Francisco Department of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridge HIV, San Francisco Department of Public Health | Recruiting | San Francisco | California | 94102 | United States |
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Randomized, controlled study
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| Standard of Care | Behavioral | Participants are given local standard of care navigation for initiation of PrEP |
|
| Alto Pharmacy | Active, not recruiting | San Francisco | California | 94107 | United States |
| ID | Term |
|---|---|
| D040242 | Risk Reduction Behavior |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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