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| Name | Class |
|---|---|
| Victory Programs | UNKNOWN |
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The goal of phase 1 is to determine the feasibility and acceptability of an intervention ('Rapid PrEP Access') providing people who use drugs (PWUD) one-time access to HIV self-testing at the Victory Program.
Aim 1: To offer HIV self-testing to PWUD in the community through a study called 'Rapid PrEP Access'. The study will be carried out at the Victory Program.
Aim 2: To determine the feasibility and acceptability of 'Rapid PrEP Access' at the Victory Program.
For phase 1 of the study, participants will be recruited for a one-time baseline interview and HIV self-testing. A questionnaire will also be administered to assess their interest in the HIV prevention pill (PrEP= pre-exposure prophylaxis), but PrEP will not be offered. Study duration for each participant is one day; participants will not be followed over time.
After the prescreener and consent forms are completed, the Research Assistant (RA) will offer the participant an opportunity to administer an HIV self-test. The participant will be provided the test for unboxing and retrieving the user instructions.
All testing will be performed and interpreted by participants. The RA can provide assistance with reading the instruction on how to obtain a proper sample. Alternatively, the RA will direct them to information in the package insert which includes support offered by the OraQuick® Support Center.
After completing the HIVST, the RA will complete the baseline questionnaire with each participant while waiting for the participants' HIVST results. After the baseline questionnaire is complete, the RA will conduct satisfaction surveys to assess acceptability of the intervention and interest of PrEP initiation using REDCap.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP Rapid Access | Experimental | Participants who are at risk of HIV and being seen at the Victory Program's Mobile Prevention Services Van. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP Rapid Access | Other | 'Rapid PrEP Access' is a low-threshold intervention designed to provide on-site access to HIV self-testing at the Victory Program for persons who use opioids. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants enrolled | Feasibility will be assessed by the number of participants enrolled | 12 months |
| Acceptability of PrEP rapid Access | Participants will rate PrEP Rapid Access' acceptability using an investigator-developed scale ranging from 1 to 5 where 1= not acceptable and 5 is very acceptable. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who perform HIV self-test | This information will be obtained from information recorded on the day of recruitment for the study. | Through study completion, an average of 1 year |
| Number of participants interested in initiating PrEP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabrina Assoumou, MD MPH | Boston Medical Center, Infectious Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victory Program | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38887480 | Derived | Assoumou SA, Bonilla HV, Ruiz-Mercado G, Von Lossnitzer M, Baker R, Crawford ND, Bernstein JA. Community-based HIV Self-testing for Persons Who Use Drugs Can Contribute to Reaching Ending the HIV Epidemic in the US (EHE) Goals. Open Forum Infect Dis. 2024 Jun 17;11(6):ofae189. doi: 10.1093/ofid/ofae189. eCollection 2024 Jun. |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059788 | Dried Blood Spot Testing |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| HIV self-testing | Other | After enrollment the research assistant (RA) will provide the participant with a HIV self-test and provide instructions on how to obtain a proper sample for the test. It uses an oral fluid test and yields results within 20 minutes. |
|
| Dried blood spot testing | Other | HIV Dried blood spot (DBS) testing provides an accurate method of measuring the HIV viral load in comparison to plasma viral load. |
|
This information will be obtained from information recorded on the day of recruitment from the survey data. |
| Through study completion, an average of 1 year |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |