Optimizing PrEP Uptake and Adherence Among Male Sex Workers
NCT ID: NCT05736614
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2022-11-03
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Study arms:
1. Stage 1 Standard of Care (SOC) Control Condition
2. Stage 1 Strength Based Case Management (SBCM) Condition
3. Stage 2 SOC Control Condition
4. Stage 2 PrEPare for Work Intervention Condition
PREVENTION
SINGLE
Study Groups
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Stage 1 Standard of Care (SOC) Control Condition
SOC participants will receive an informational pamphlet about the PrEP as a form of HIV prevention and referrals to local PrEP Prescribers.
No interventions assigned to this group
Stage 1 Strength Based Case Management (SBCM) Condition
Intervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment.
Stage 1 Strength Based Case Management (SBCM) Condition
Intervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment.
Stage 2 SOC Control Condition
Research staff will show a brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission. Participants will continue to see their PrEP prescriber for routine clinical care.
No interventions assigned to this group
Stage 2 PrEPare for Work Intervention Condition
Intervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist.
Stage 2 PrEPare for Work Intervention Condition
Intervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist.
Interventions
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Stage 1 Strength Based Case Management (SBCM) Condition
Intervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment.
Stage 2 PrEPare for Work Intervention Condition
Intervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist.
Eligibility Criteria
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Inclusion Criteria
* Assigned male sex at birth
* Identifies as male at enrollment
* Report having engaged in condomless anal sex with another man in the past 3 months
* Report having exchanged sex for money, drugs, items of value, or a place to stay with another man in the past 3 months
* Report HIV status as negative or unsure
* Not currently on PrEP
* Able to understand and speak English or Spanish
Exclusion
* Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview (will use an adapted version of the Evaluation to Sign Consent Form65 to assess capacity)
* Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment)
* Laboratory or clinical findings that would preclude PrEP initiation (e.g. Chronic Hepatitis B Virus infection, decreased creatinine clearance)
* Participated in the pilot RCT and initiated PrEP during study participation
18 Years
MALE
Yes
Sponsors
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The Miriam Hospital
OTHER
University of California, Los Angeles
OTHER
Project Weber/RENEW
UNKNOWN
Open Door Health
UNKNOWN
National Institute of Nursing Research (NINR)
NIH
Brown University
OTHER
Responsible Party
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Principal Investigators
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Katie Biello, PhD
Role: PRINCIPAL_INVESTIGATOR
Brown University School of Public Health
Locations
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UCLA Fielding School of Public Health
Los Angeles, California, United States
The Miriam Hospital
Providence, Rhode Island, United States
Open Door Health
Providence, Rhode Island, United States
Project Weber/RENEW
Providence, Rhode Island, United States
Brown University School of Public Health
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Biello KB, Chan PA, Ndoye CD, Nelson L, Nelson E, Silva V, Kwak E, Napoleon S, Cormack Orellana C, Richards OG, Davis E, Mimiaga MJ. Study protocol of a randomized controlled trial to assess the efficacy of the "PrEPare for Work" intervention to enhance PrEP uptake and optimize adherence for HIV prevention among male sex workers in the U.S. BMC Public Health. 2024 Feb 9;24(1):424. doi: 10.1186/s12889-024-17710-y.
Other Identifiers
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2001002627
Identifier Type: -
Identifier Source: org_study_id
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