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Completed

NCT Number: NCT03086057

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

"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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Brown University School of Public Health, Providence, Rhode Island, United States

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About this study

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

  • Strengths-based case management for PrEP initiation, and
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

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

Behavioral

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

Primary outcomes

  1. Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic

    Time frame: 2-month post Stage 1 randomization

    Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records

  2. Number of Participants Who Initiated PrEP

    Time frame: 2-month post Stage 1 randomization

    Initial prescription from provider filled and shown to study staff

  3. Number of Participants Reporting Optimal PrEP Adherence

    Time frame: 6-months post Stage 2 randomization

    Self-reporting missing 0 PrEP pills in the past week

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • The Miriam Hospital

Registry information

Official study title

Optimizing Pre-exposure Prophylaxis (PrEP) Uptake & Adherence Among MSW Using a 2-stage Randomization Design

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2017
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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