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| Name | Class |
|---|---|
| The Miriam Hospital | OTHER |
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"PrEPare for Work" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Male Sex Workers (MSW).
The "PrEPare for Work" package includes two behavioral intervention components:
Stage 1: MSW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic.
Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEPare for Work" adherence intervention or standard of care comparison condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strength Based Case Management | Experimental | Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. |
|
| PrEP adherence training and counseling | Experimental | Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. |
|
| Standard of Care:Stage 1 | No Intervention | Stage 1: Referral to The Miriam Hospital PrEP Clinic. | |
| Standard of Care: Stage 2 | No Intervention | Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEPare for Work: Strength Based Case Management (Stage 1) | Behavioral | Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic | Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records | 2-month post Stage 1 randomization |
| Number of Participants Who Initiated PrEP | Initial prescription from provider filled and shown to study staff | 2-month post Stage 1 randomization |
| Number of Participants Reporting Optimal PrEP Adherence | Self-reporting missing 0 PrEP pills in the past week | 6-months post Stage 2 randomization |
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Inclusion Criteria:
Exclusion Criteria:
Biological male at birth and current male gender identity
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Mimiaga, ScD, MPH | Brown University, School of Public Health, Center for Health Equity Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States | ||
| Brown University School of Public Health |
It is anticipated that this data will be presented annually on data collected after the second year when sufficient baseline data is collected. It is anticipated that most of the papers and data-based projects/presentations will happen in year 3, when all of the baseline data is collected, and the 3 month outcome has occurred for all participants. Sharing of the findings will involve a primary paper describing the study outcome and a paper that describes the intervention, as well as submitting to lead workshops on the intervention approach at relevant national meetings and conferences. Raw data for additional analysis will be available to outside individuals through contacting the MPIs. Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.
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One participant was partially enrolled and never completed enrollment. Only participants who completed Stage 1 AND who initiated PrEP were included in Stage 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Strength Based Case Management | Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1: PrEP Uptake |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2019 | Jul 8, 2019 |
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In Stage 1, individuals will be randomized (1:1) to receive the experimental PrEP navigation or standard of care. Among those who uptake PrEP in Stage 1, we will randomize those participants in Stage 2 (1:1) to receive the experimental adherence counseling or standard of care.
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| PrEPare for Work: Adherence Training and Counseling (Stage 2) | Behavioral | Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. |
|
| Providence |
| Rhode Island |
| 02912 |
| United States |
| FG001 |
| Standard of Care:Stage 1 |
Stage 1: Referral to The Miriam Hospital PrEP Clinic. |
| FG002 | PrEP Adherence Training and Counseling | Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. |
| FG003 | Standard of Care: Stage 2 | Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test. |
| COMPLETED |
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| NOT COMPLETED |
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| Stage 2: PrEP Adherence |
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This was a two-stage sequential randomization design. Therefore, all of those in the Stage 2 arms (PrEP adherence training and counseling and Standard of Care) are already counted in Stage 1 arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Strength Based Case Management | Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. |
| BG001 | Standard of Care:Stage 1 | Stage 1: Referral to The Miriam Hospital PrEP Clinic. |
| BG002 | PrEP Adherence Training and Counseling | Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. |
| BG003 | Standard of Care: Stage 2 | Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| PrEP Use Self-Efficacy | Summary measure - range 0-10, with higher scores indicating higher self-efficacy for using PrEP | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic | Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records | Per study design, linkage to PrEP care was only assessed in Stage 1; Additionally, because this was based on medical records we could include anyone that was not withdrawn or incarcerated or had died (n=5 in each arm). | Posted | Count of Participants | Participants | 2-month post Stage 1 randomization |
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| Primary | Number of Participants Who Initiated PrEP | Initial prescription from provider filled and shown to study staff | Per study design, PrEP initiation was only assessed in Stage 1; Additionally, because this required proof of prescription, we excluded those who were loss to follow up for Stage 1. | Posted | Count of Participants | Participants | 2-month post Stage 1 randomization |
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| Primary | Number of Participants Reporting Optimal PrEP Adherence | Self-reporting missing 0 PrEP pills in the past week | Per study design, PrEP adherence was only assessed in Stage 2 (and among Stage 2 participants); Additionally, because this was based on self-report, PrEP adherence was only assessed among those with follow up data. | Posted | Count of Participants | Participants | 6-months post Stage 2 randomization |
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For participants only in Stage 1, adverse event data were collected for approximately 2 months for each participant. For participants subsequently randomized into Stage 2, adverse event data were collected for an additional 6 months for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strength Based Case Management | Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. PrEPare for Work: Strength Based Case Management (Stage 1): Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. | 1 | 55 | 0 | 55 | 0 | 55 |
| EG001 | Standard of Care:Stage 1 | Stage 1: Referral to The Miriam Hospital PrEP Clinic. | 2 | 55 | 0 | 55 | 0 | 55 |
| EG002 | PrEP Adherence Training and Counseling | Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. PrEPare for Work: Adherence Training and Counseling (Stage 2): Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. | 0 | 17 | 0 | 17 | 3 | 17 |
| EG003 | Standard of Care: Stage 2 | Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test. | 0 | 18 | 0 | 18 | 0 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Potential Disclosure | Social circumstances | Non-systematic Assessment |
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| Homicidal ideation | Social circumstances | Non-systematic Assessment |
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| Police involvement | Social circumstances | Non-systematic Assessment | Using study phone to call police (but then hang up) |
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Due to COVID, we are delayed in receiving the results of our biomarkers (specifically, hair analysis for PrEP adherence).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katie Biello | Brown University | 401-863-3082 | katie_biello@brown.edu |
| ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 3, 2018 | Feb 3, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 15, 2015 | Feb 22, 2021 | SAP_002.pdf |
| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Male |
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| Black, non-Hispanic |
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| Hispanic/Latino |
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| Other |
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