Optimizing PrEP Uptake and Adherence Among Male Sex Workers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stage 1 Strength Based Case Management (SBCM) Condition, Stage 2 PrEPare for Work Intervention Condition.
- Who it may be relevant to
- Registry conditions: Prevention. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of a PrEP Uptake & Adherence Intervention Among Male Sex Workers Using a 2-stage Randomization Design
Overview
"PrEPare for Work" is a randomized controlled trial (RCT) whose goal is to test the efficacy of a behavioral intervention (Short Title: PrEPare for Work) in improving PrEP uptake, adherence, and persistence among male sex workers (MSW)
Detailed description
A theory-based, manualized intervention -called "PrEPare for Work"-includes two separate but complementary interventions that address MSW-specific behavioral, economic, interpersonal \& structural-level barriers to accessing and adhering to PrEP: 1) peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake; and 2) a technology and counseling intervention to optimize PrEP adherence (once they have access to PrEP). This research will test the PrEPare for Work intervention in a fully-powered RCT to assess efficacy and cost-effectiveness.
Interventions
- Behavioral 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. - Behavioral 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.
Primary outcome measures
- Stage one: PrEP initiation [Time frame: 2-month post Stage 1 randomization]
- Stage two: PrEP adherence [Time frame: 12-month post Stage 2 randomization]
Secondary outcome measures (1)
- PrEP persistence [Time frame: 12-month post Stage 2 randomization]
Eligibility criteria
Inclusion
- Age: 18 years or older
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 5 centers
- UCLA Fielding School of Public Health — Los Angeles
- The Miriam Hospital — Providence
- Open Door Health — Providence
- Project Weber/RENEW — Providence
- Brown University School of Public Health — Providence
Publications
- 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/s12 PMID 38336731
Identifiers
NCT: NCT05736614 · 2001002627 · R01NR020227