Pre-exposure Prophylaxis (PrEP) for Health (PrEP)

April 30, 2025 updated by: Brown University

Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast

This randomized controlled trial will test the efficacy of "PrEP for Health," a behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in Lawrence and Boston/Cambridge, Massachusetts. The investigators will equally randomize 200 PWID to receive either (a) the "PrEP for Health" intervention condition involving theory-informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation (n=100), or (b) the standard of care condition involving PrEP information and referrals (n=100). Successful PrEP uptake (via medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) will be evaluated. The degree to which intervention efficacy occurs through specific conceptual mediators and differs according to hypothesized moderators will also be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The overall goal of this proposal is to evaluate the efficacy of the "PrEP for Health" navigator delivered behavioral intervention in improving PrEP uptake (via medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) among PWID in SSPs. Eligible PWID (n=200 total; 100 recruited from each study site) will be equally randomized to an active PrEP for Health intervention arm (n=100) or a Standard of Care control condition (n=100). Assessments will be conducted at baseline and 1, 3, 6, and 12 months after randomization.

We hypothesize that brief, multi-component behavioral intervention sessions with ongoing support delivered by trained PrEP Navigators within Syringe Service Programs (SSPs) will improve PrEP uptake, adherence, and long-term adherence in PWID by increasing HIV and PrEP knowledge (including alleviating concerns about side effects), increasing HIV risk perceptions and PrEP interest and motivation, improving PrEP use self-efficacy and behavioral skills, and reducing structural barriers over time. Based on our formative research, we also hypothesize that the strength of intervention effects may differ by key individual characteristics (age, gender, baseline sexual risk, polysubstance, and stimulant use).

This is a randomized control trial (RCT). Participants will be recruited via outreach specialist at SSP sites and during routine community outreach practices of the organizations. After eligibility confirmation and baseline assessments, participants will be randomized to one of two study arms: 1) Standard of Care (SOC) Control Condition: as routinely provided through the SSP study sites, participants will receive information and services according to routine practice and a brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission; 2) "PrEP for Health" Intervention Condition: a trained PrEP Navigator will deliver a manualized PrEP uptake and adherence intervention in private counseling rooms at SSPs followed by 3 months of additional PrEP navigation support through in-person, phone, and text interactions as needed. Participants will complete a total of four follow-up visits over a 12-month period. Participants who initiate PrEP will have a hair sample collected at 3-, 6-, and 12-month visits. All participants will receive a rapid HIV screening test at 12-month follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Recruiting
        • AIDS Action
        • Principal Investigator:
          • Michelle Bordeu, MPH
        • Contact:
      • Lawrence, Massachusetts, United States, 01841
        • Recruiting
        • Greater Lawrence Family Health Center
        • Contact:
        • Principal Investigator:
          • Christopher Bositis, MD
        • Principal Investigator:
          • Katrina Baumgartner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • HIV-uninfected (verified by rapid/4th generation test)
  • Reporting past-month injection of any drugs
  • One or more HIV risk behaviors (past-month receptive syringe sharing, transactional sex, or condomless sex with an HIV-infected or unknown-status partner)
  • Not currently on and never taken PrEP
  • Able to understand and speak English or Spanish

Exclusion Criteria:

  • Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of enrollment
  • Living in Massachusetts (MA) for <3 months
  • Planning to move out of MA within a year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PrEP for health
Participants in the PrEP (pre-exposure prophylaxis) for health arm will receive theory informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation.
Other: HIV and PrEP education
Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.
Behavioral: Motivational interviewing
Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.
Behavioral: Problem-solving and planning
Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.
Behavioral: Patient navigation
Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites
Other: PrEP information
A brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.
Active Comparator: Standard of care
Participants in the standard of care arm will receive PrEP information and referrals.
Other: PrEP information
A brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.
Other: Referrals
Study staff will provide basic information about PrEP and referrals to PrEP clinicians.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PrEP uptake
Time Frame: 3 months
PrEP uptake will be assessed via medical/pharmacy records
3 months
Post-treatment PrEP adherence
Time Frame: 3 months
PrEP adherence will be assessed by drug levels in hair samples at the acute follow up time point (3 months post-baseline)
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Longer-term PrEP adherence
Time Frame: 6 and 12 months
Longer-term PrEP adherence will be assessed by drug levels in hair samples at 6 and 12-month post-baseline
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brown University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
University of California, San Diego
Beth Israel Deaconess Medical Center
The Fenway Institute
AIDS Action Committee of Massachusetts
Greater Lawrence Family Health Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katie Biello, PhD, MPH, Brown University
  • Principal Investigator: Angela Bazzi, PhD, MPH, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011002841
  • R01DA051849-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

By request to the study investigators

IPD Sharing Time Frame

Data will be available after the study has closed and after publication of the primary study findings.

IPD Sharing Access Criteria

Requests will be reviewed by the principal investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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