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Pre-exposure Prophylaxis (PrEP) for People Who Inject Drugs (PWID)

NCT03869671 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-03-10

No results posted yet for this study

Summary

People who inject drugs (PWID) experience high risk of HIV acquisition. Antiretroviral pre-exposure prophylaxis (PrEP) is an efficacious biomedical HIV prevention strategy for high risk HIV-uninfected individuals including PWID, yet uptake has been low in this population and uptake and adherence interventions have not been developed or tested. Drawing from formative qualitative research, the overall goal of this project is to develop an intervention to promote PrEP uptake and adherence among PWID in the U.S. Northeast. The investigators will:

* Analyze existing literature and data to identify specific barriers and facilitators to PrEP uptake and adherence among PWID to inform the initial adaptation of existing theory-based interventions;
* Conduct qualitative interviews with \~30 PWID and \~10 key informants (PrEP and other clinical and social service providers) to identify intervention targets;
* Develop and iteratively refine and finalize an intervention manual based on feedback from qualitative exit-interviews with an interventionist and \~10 PWID; and
* Conduct a pilot randomized clinical trial (RCT) in \~50 HIV-uninfected PWID to compare PrEP uptake and adherence outcomes and assess intervention feasibility and acceptability.

Conditions

  • Intravenous Drug Abuse

Interventions

BEHAVIORAL

PrEP uptake/adherence intervention

The interventionist will follow the manual to deliver informational and motivational strategies to participants to enhance their PrEP uptake (including completing clinical screening and obtaining/filling a PrEP prescription) and adherence (taking daily oral PrEP doses). The interventionist will assist participants in problem-solving around topics including limited transportation options, identifying local pharmacies, storing medications given complex living arrangements, coping with side effects, communicating with providers and pharmacists, and maintaining daily medication schedules with reminders and cues.

BEHAVIORAL

Harm reduction standard of care

Participants will be provided with harm reduction supplies and health information and counseling according to routine practice at the community-based setting (harm reduction organization).

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Boston University

    lead OTHER

Principal Investigators

  • Angela Bazzi, PhD, MPH · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2022-03-31
Completion
2022-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869671 on ClinicalTrials.gov