Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design

Brown University

Status: Completed

Conditions: Prevention

Treatments: Behavioral: PrEPare for Work: Adherence Training and Counseling (Stage 2); Behavioral: PrEPare for Work: Strength Based Case Management (Stage 1)

Study type: Interventional

Funder types: Other

Identifiers

NCT03086057

1R34MH110369-01

Details and patient eligibility

About

"PrEPare for Work" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Male Sex Workers (MSW).

Full description

The "PrEPare for Work" package includes two behavioral intervention components:

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.

Enrollment: 111 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• 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

• Unable to provide informed consent, including as a result of severe mental illness requiring immediate treatment or mental illness limiting the ability to participate
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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111 participants in 4 patient groups

Strength Based Case Management

Experimental group

Description:

Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.

Treatment:

Behavioral: PrEPare for Work: Strength Based Case Management (Stage 1)

PrEP adherence training and counseling

Experimental group

Description:

Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.

Treatment:

Behavioral: PrEPare for Work: Adherence Training and Counseling (Stage 2)

Standard of Care:Stage 1

No Intervention group

Description:

Stage 1: Referral to The Miriam Hospital PrEP Clinic.

Standard of Care: Stage 2

No Intervention group

Description:

Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.