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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH134269-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to assess the effectiveness of the FPI bundled implementation strategy in increasing HIV testing, Pre-exposure prophylaxis (PrEP) linkage (e.g., prescription) and knowledge, and condom use/access.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FPI Group | Experimental | Participants in this group will receive the FPI intervention at any FPI coordinated outreach event (4-5 hours) during a 21 month period |
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| Pre-intervention Assessment Group | No Intervention | We will conduct pre-assessment events (4-5 hours) during 1.5 months in each zip code (prior to the introduction of the FPI intervention) to capture information from residents /participants via survey. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FPI | Behavioral | The FPI intervention will be conducted twice per month (across 21 months) in a zip code, and each event will last approximately 4-5 hours. At the event, participants will receive HIV testing, PrEP linkage (e.g., prescription) and knowledge, and condom and use/access. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of residents with recent HIV testing | Will be reported as proportion of residents with recent (within 12 months) HIV testing as measured by Five Point Initiative - Community Survey | Up to 23 months |
| Change in number of residents with PrEP prescription | Will be reported as proportion of residents with PrEP prescription as measured by Five Point Initiative - Community Survey | Up to 23 months |
| Change in PrEP knowledge as measured by Five Point Initiative - Community Survey | Will be reported as the proportion of residents that indicated 'Yes' on the survey. | Baseline and up to 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in condom use as measured by Five Point Initiative - Community Survey | Will be reported as the proportion of residents that indicated 'No' on the survey | Baseline and up to 23 months |
| Change in condom access as measured by Five Point Initiative - Community Survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sannisha Dale, PhD | Contact | (305) 243-6714 | sdale@med.miami.edu | |
| SHINE Research Program | Contact | shineresearch@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sannisha Dale, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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This is a stepped wedge trial and all zip codes cross over from pre-assessment period (control) to active intervention. The time/order in which zip codes enter the stepped wedge is the unity of randomization.
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Will be reported as the proportion of residents that indicated 'Yes' on the survey |
| Baseline and up to 23 months |
| Proportion of residents with recent HIV testing by health organizations | Proportion of residents with recent (within 12 months) HIV testing by each of the participating health organizations. | Up to 23 months |
| Number of residents with PrEP prescription by health organizations | Number of residents with PrEP prescription by each of the participating health organizations. | Up to 23 months |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |