Intravenous Drug AbuseNCT03869671
Pre-exposure Prophylaxis (PrEP) for People Who Inject Drugs (PWID)
A study testing PrEP uptake/adherence intervention in people with Intravenous Drug Abuse, run by Boston University.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravenous Drug Abuse
- What is being tested?
- PrEP uptake/adherence intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Clinically eligible for PrEP (confirmed HIV-uninfected status, adequate renal function [estimated creatinine clearance ≥60 ml/min], and documented hepatitis B virus [HBV] status)
Who cannot join
- Unable or unwilling to provide informed consent
- For Phase 3 (the RCT pilot):
About this study
Official title: Optimizing Bio-behavioral HIV Prevention Approaches for People Who Inject Drugs
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.
Read the detailed 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).
- Conditions
- Intravenous Drug Abuse
- Being tested
- PrEP uptake/adherence intervention, Harm reduction standard of care
- Keywords
- Antiretroviral pre-exposure prophylaxis (PrEP), Syringe exchange program (SEP), HIV-related risk behaviors, Adherence intervention, People who inject drugs (PWID)
- Medical subject headings
- Substance Abuse, Intravenous, Adherence Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP uptake/adherence interventionBehavioural
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 careBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| PrEP uptake/adherence intervention | Experimental | A trained interventionist will deliver the manualized, single session PrEP uptake/adherence intervention in private counseling rooms at a community-based setting. Receives: Behavioral: PrEP uptake/adherence intervention |
| Harm reduction standard of care | Active comparator | Participants will be provided harm reduction supplies and health information and counseling according to routine practice at the community-based setting. Receives: Behavioral: Harm reduction standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP uptake by self-report
measured using 1 item in a structured questionnaire
Measured: 1 month
PrEP uptake by self-report
measured using 1 item in a structured questionnaire
Measured: 3 months
PrEP uptake by pharmacy records
measured by accessing pharmacy records
Measured: 1 month
PrEP uptake by pharmacy records
measured by accessing pharmacy records
Measured: 3 months
PrEP adherence by self-report
measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed
Measured: 1 month
PrEP adherence by self-report
measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed
Measured: 3 months
PrEP adherence by dried blood spot
measured via detection of tenofovir and emtricitabine in dried blood spots (DBS)
Measured: 1 month
PrEP adherence by dried blood spot
measured via detection of tenofovir and emtricitabine in dried blood spots (DBS)
Measured: 3 months
Secondary outcomes (6)
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study startMar 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: The study design was changed and this clinical trial will not be conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous Drug AbuseStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Angela Bazzi, PhD, MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869671
- Sponsor's protocol ID
- H-34960
- Other IDs
- K01DA043412-01A1
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2019
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Bio-behavioral HIV Prevention Approaches for People Who Inject Drugs
- ClinicalTrials.gov ID
- NCT03869671
- Acronym / sponsor ID
- H-34960
- Conditions
- Intravenous Drug Abuse
- Keywords
- Antiretroviral pre-exposure prophylaxis (PrEP), Syringe exchange program (SEP), HIV-related risk behaviors, Adherence intervention, People who inject drugs (PWID)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study design was changed and this clinical trial will not be conducted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEP uptake/adherence intervention | Experimental | Behavioral: PrEP uptake/adherence interventionA 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 comparator | Behavioral: Harm reduction standard of careParticipants will be provided harm reduction supplies and health information and counseling according to routine practice at the community-based setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
- Clinically eligible for PrEP (confirmed HIV-uninfected status, adequate renal function [estimated creatinine clearance ≥60 ml/min], and documented hepatitis B virus [HBV] status)
Key exclusion criteria (2 listed)
- Unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP uptake/adherence interventionThe 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. | Behavioural | PrEP uptake/adherence intervention |
| Harm reduction standard of careParticipants will be provided with harm reduction supplies and health information and counseling according to routine practice at the community-based setting (harm reduction organization). | Behavioural | Harm reduction standard of care |
Primary outcome
PrEP uptake by self-report
Time frame: 1 month
measured using 1 item in a structured questionnaire
PrEP uptake by self-report
Time frame: 3 months
measured using 1 item in a structured questionnaire
PrEP uptake by pharmacy records
Time frame: 1 month
measured by accessing pharmacy records
PrEP uptake by pharmacy records
Time frame: 3 months
measured by accessing pharmacy records
PrEP adherence by self-report
Time frame: 1 month
measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed
PrEP adherence by self-report
Time frame: 3 months
measured using 1 item in a structured questionnaire to determine the proportion of doses taken as prescribed
PrEP adherence by dried blood spot
Time frame: 1 month
measured via detection of tenofovir and emtricitabine in dried blood spots (DBS)
PrEP adherence by dried blood spot
Time frame: 3 months
measured via detection of tenofovir and emtricitabine in dried blood spots (DBS)
6 secondary outcomes
Participant satisfaction with intervention content
Time frame: 1 month
Participant satisfaction with intervention delivery methods
Time frame: 1 month
Interventionist satisfaction with training materials
Time frame: 1 month
Interventionist satisfaction with intervention manual
Time frame: 1 month
Interventionist satisfaction with intervention content
Time frame: 1 month
Interventionist satisfaction with intervention delivery methods
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Intravenous Drug Abuse
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Enrolling by invitationObservational study
Histiocytosis in Injecting Drug Users
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Bazzi, PhD, MPH principal investigator
Boston University
Questions about this trial
What is this clinical trial studying?
A study testing PrEP uptake/adherence intervention in people with Intravenous Drug Abuse, run by Boston University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP uptake by self-report (time frame: 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.