Study Stopped
The study design was changed and this clinical trial will not be conducted.
Pre-exposure Prophylaxis (PrEP) for People Who Inject Drugs (PWID)
Optimizing Bio-behavioral HIV Prevention Approaches for People Who Inject Drugs
2 other identifiers
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMarch 10, 2021
March 1, 2021
1 year
March 8, 2019
March 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
PrEP uptake by self-report
measured using 1 item in a structured questionnaire
1 month
PrEP uptake by self-report
measured using 1 item in a structured questionnaire
3 months
PrEP uptake by pharmacy records
measured by accessing pharmacy records
1 month
PrEP uptake by pharmacy records
measured by accessing pharmacy records
3 months
PrEP adherence by self-report
measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed
1 month
PrEP adherence by self-report
measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed
3 months
PrEP adherence by dried blood spot
measured via detection of tenofovir and emtricitabine in dried blood spots (DBS)
1 month
PrEP adherence by dried blood spot
measured via detection of tenofovir and emtricitabine in dried blood spots (DBS)
3 months
Secondary Outcomes (6)
Participant satisfaction with intervention content
1 month
Participant satisfaction with intervention delivery methods
1 month
Interventionist satisfaction with training materials
1 month
Interventionist satisfaction with intervention manual
1 month
Interventionist satisfaction with intervention content
1 month
- +1 more secondary outcomes
Study Arms (2)
PrEP uptake/adherence intervention
EXPERIMENTALA trained interventionist will deliver the manualized, single session PrEP uptake/adherence intervention in private counseling rooms at a community-based setting.
Harm reduction standard of care
ACTIVE COMPARATORParticipants will be provided harm reduction supplies and health information and counseling according to routine practice at the community-based setting.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- An adult PWID
- Self report of any high risk behaviors for HIV (past-month receptive syringe sharing, transactional sex, condomless sex with an HIV-infected or unknown status partner)
You may not qualify if:
- Unable or unwilling to provide informed consent
- For Phase 3 (the RCT pilot):
- Clinically eligible for PrEP (confirmed HIV-uninfected status, adequate renal function \[estimated creatinine clearance ≥60 ml/min\], and documented hepatitis B virus \[HBV\] status)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Bazzi, PhD, MPH
Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2019
First Posted
March 11, 2019
Study Start
March 1, 2021
Primary Completion
March 1, 2022
Study Completion
March 1, 2022
Last Updated
March 10, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share