RECRUITING

Pre-exposure Prophylaxis (PrEP) for Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-09-02
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04430257

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * HIV-uninfected (verified by rapid/4th generation test)
  2. * Reporting past-month injection of any drugs
  3. * One or more HIV risk behaviors (past-month receptive syringe sharing, transactional sex, or condomless sex with an HIV-infected or unknown-status partner)
  4. * Not currently on and never taken PrEP
  5. * Able to understand and speak English or Spanish
  1. * Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of enrollment
  2. * Living in Massachusetts (MA) for \<3 months
  3. * Planning to move out of MA within a year

Contacts and Locations

Study Contact

Katie Biello, PhD, MPH
CONTACT
401-863-6551
katie_biello@brown.edu
Angela Bazzi, PhD
CONTACT
abazzi@health.ucsd.edu

Principal Investigator

Katie Biello, PhD, MPH
PRINCIPAL_INVESTIGATOR
Brown University
Angela Bazzi, PhD, MPH
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

AIDS Action
Cambridge, Massachusetts, 02139
United States
Greater Lawrence Family Health Center
Lawrence, Massachusetts, 01841
United States

Collaborators and Investigators

Sponsor: Brown University

  • Katie Biello, PhD, MPH, PRINCIPAL_INVESTIGATOR, Brown University
  • Angela Bazzi, PhD, MPH, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-09-02
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2021-09-02
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

  • PrEP (pre-exposure prophylaxis )
  • PWID (people who inject drugs)
  • SSP (syringe service program)
  • HIV education
  • Motivational interviewing
  • Self efficacy
  • Social cognitive theory

Additional Relevant MeSH Terms

  • Substance Dependence
  • HIV (Human Immunodeficiency Virus)