Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design
NCT ID: NCT03086057
Last Updated: 2021-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2017-05-01
2019-12-15
Brief Summary
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Detailed Description
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1. Strengths-based case management for PrEP initiation, and
2. Counseling and problem-solving PrEP adherence intervention that addresses individualized barriers to optimal use.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
Standard of Care:Stage 1
Stage 1: Referral to The Miriam Hospital PrEP Clinic.
No interventions assigned to this group
Standard of Care: Stage 2
Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Biological male at birth and current male gender identity
* Exchanged sex for money or drugs with another man in the past 3 months
* Report behavioral risk for HIV infection, consistent with Centers for Disease Control and Prevention guidelines for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the past three months
* HIV uninfected by antibody test\* Stage 2
* Able to understand and speak English (for consent and counseling)
* Mental competency to provide voluntary informed consent
* Lives in the New England area
* Willing to initiate PrEP
Exclusion Criteria
* HIV Positive at baseline
* Infected with Hepatitis B or diagnosed with renal insufficiency (glomerular filtration rate \< 50) \*Stage 2
* History of or current medical conditions that would preclude taking Truvada for PrEP \*Stage 2
* Currently taking Truvada for PrEP
18 Years
MALE
Yes
Sponsors
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The Miriam Hospital
OTHER
Brown University
OTHER
Responsible Party
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Matthew Mimiaga
ScD, MPH
Principal Investigators
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Matthew J Mimiaga, ScD, MPH
Role: PRINCIPAL_INVESTIGATOR
Brown University, School of Public Health, Center for Health Equity Research
Locations
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The Miriam Hospital
Providence, Rhode Island, United States
Brown University School of Public Health
Providence, Rhode Island, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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