Clinical trial NCT05736614: Optimizing PrEP Uptake and Adherence Among Male Sex Workers
Official title: Efficacy of a PrEP Uptake & Adherence Intervention Among Male Sex Workers Using a 2-stage Randomization Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prevention
Keywords: PrEP
Prevention
Male Sex Workers (MSW)
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
name: University of California, Los Angeles
name: Project Weber/RENEW
name: Open Door Health
name: National Institute of Nursing Research (NINR)
First posted: 2023-02-21
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (RCT)

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
Primary purpose: PREVENTION

Brief summary: "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.

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

Primary outcomes:
measure: Stage one: PrEP initiation
timeFrame: 2-month post Stage 1 randomization
measure: Stage two: PrEP adherence
timeFrame: 12-month post Stage 2 randomization
Secondary outcomes:
measure: PrEP persistence
timeFrame: 12-month post Stage 2 randomization
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Fielding School of Public Health
state: California
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Providence
country: United States
facility: Open Door Health
state: Rhode Island
city: Providence
country: United States
facility: Project Weber/RENEW
state: Rhode Island
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University School of Public Health
name: Katie Biello, PhD
role: PRINCIPAL_INVESTIGATOR
References: