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

Intravenous Drug Abuse Clinical Trial

Official title:

Optimizing Bio-behavioral HIV Prevention Approaches for People Who Inject Drugs

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03869671
• Other study ID #: H-34960
• Secondary ID: K01DA043412-01A1
• Status: Withdrawn
• Phase: N/A
• Start date: March 2021
• Est. completion date: March 2022

Study information

• Verified date: March 2021
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This mixed methods phased research will use qualitative and quantitative techniques to improve PrEP uptake and adherence among PWID through the following three phases:

• Phase 1 will identify the modifiable determinants of PrEP uptake and adherence among HIV-uninfected PWID using in-depth qualitative interviews with PWID and key informants (KIs). Qualitative interviews will explore perceived acceptability and identify barriers and facilitators to PrEP uptake and adherence among ~30 HIV-uninfected PWID and explore perspectives on optimal PrEP delivery methods with ~15 KIs (e.g., PrEP physicians, community-based organization staff members with experience working with PWID).

• Phase 2 will involve identifying intervention targets and adapting existing intervention strategies to improve PrEP uptake and adherence among PWID. This will involve reviewing the literature to identify and select components of existing, evidence-based medication adherence interventions to adapt for the unique determinants of PrEP uptake and adherence among PWID. Investigators will then develop and iteratively refine and finalize an intervention manual by conducting an open-pilot of the intervention in a community-based setting. Refinements will be based on feedback from qualitative exit-interviews with the interventionist and ~10 PWID.

• Phase 3 will involve pilot testing the resulting PrEP uptake and adherence intervention in a selected community-based setting to obtain preliminary data on PrEP uptake and adherence outcomes (primary outcomes) and intervention feasibility and acceptability (secondary outcomes). Investigators will use a pilot RCT design with a mixed methods process evaluation in which 50 HIV-uninfected PWID will be randomized to the PrEP intervention or a control condition (SEP standard of care; n=25 per arm). Investigators will assess changes in PrEP outcomes (primary outcomes of uptake and adherence) and key implementation measures (e.g., secondary outcomes of acceptability, feasibility, adoption by the interventionist).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For all phases:

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Unable or unwilling to provide informed consent

For Phase 3 (the RCT pilot):

Inclusion Criteria:

• Clinically eligible for PrEP (confirmed HIV-uninfected status, adequate renal function [estimated creatinine clearance =60 ml/min], and documented hepatitis B virus [HBV] status)

Related Conditions & MeSH terms

• Intravenous Drug Abuse
• Substance Abuse, Intravenous
• Substance-Related Disorders

Intervention

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.
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP uptake by self-report	measured using 1 item in a structured questionnaire	1 month
Primary	PrEP uptake by self-report	measured using 1 item in a structured questionnaire	3 months
Primary	PrEP uptake by pharmacy records	measured by accessing pharmacy records	1 month
Primary	PrEP uptake by pharmacy records	measured by accessing pharmacy records	3 months
Primary	PrEP adherence by self-report	measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed	1 month
Primary	PrEP adherence by self-report	measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed	3 months
Primary	PrEP adherence by dried blood spot	measured via detection of tenofovir and emtricitabine in dried blood spots (DBS)	1 month
Primary	PrEP adherence by dried blood spot	measured via detection of tenofovir and emtricitabine in dried blood spots (DBS)	3 months
Secondary	Participant satisfaction with intervention content	assessed via qualitative exit interviews exploring satisfaction with the intervention content (including an open-ended question on topics that were helpful and unhelpful)	1 month
Secondary	Participant satisfaction with intervention delivery methods	assessed via qualitative exit interviews exploring satisfaction with the intervention delivery methods (including an open-ended question on how helpful or unhelpful the intervention delivery methods were)	1 month
Secondary	Interventionist satisfaction with training materials	assessed via qualitative exit interviews exploring satisfaction with the training materials for interventionists (including an open-ended question on how helpful or unhelpful the training materials were)	1 month
Secondary	Interventionist satisfaction with intervention manual	assessed via qualitative exit interviews exploring satisfaction with the intervention manual (including an open-ended question on how helpful or unhelpful the intervention manual was)	1 month
Secondary	Interventionist satisfaction with intervention content	assessed via qualitative exit interviews exploring satisfaction with the intervention content (including an open-ended question on topics that were helpful and unhelpful)	1 month
Secondary	Interventionist satisfaction with intervention delivery methods	assessed via qualitative exit interviews exploring satisfaction with the training materials, intervention manual, intervention content, intervention delivery methods (including an open-ended question on how helpful or unhelpful the intervention delivery methods were)	1 month