Prevention
Conditions
Keywords
PrEP, Prevention, Male Sex Workers (MSW)
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.
Interventions
BEHAVIORALStage 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.
BEHAVIORALStage 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.
Sponsors
The Miriam Hospital
University of California, Los Angeles
Project Weber/RENEW
Open Door Health
National Institute of Nursing Research (NINR)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
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
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage one: PrEP initiation | 2-month post Stage 1 randomization | Stage one: PrEP initiation will be measured via verification of prescription filled within two months post-randomization, associated medical records from a PrEP prescriber, and self-report. |
| Stage two: PrEP adherence | 12-month post Stage 2 randomization | Stage two: PrEP adherence will be measured via tenofovir concentration in hair. Self-reported adherence will supplement biological monitoring data at 4-month intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP persistence | 12-month post Stage 2 randomization | PrEP persistence will be measured via medical records and self-report. We will assess PrEP persistence using medical and pharmacy records to confirm provider follow-up visits and prescription refill maintenance. As per Coy et al., PrEP persistence will be defined as having ≥16 days of PrEP medication filled per 30-day period, for at least three-quarters of the months since initiation to study completion (\ 9 months). |
Countries
United States
Contacts
Primary ContactKatie Biello, PhD
Backup ContactMatthew Mimiaga, ScD MPH
Outcome results
None listed