Substance DependencePrEPNCT04430257
Pre-exposure Prophylaxis (PrEP) for Health
A study testing HIV and PrEP education, Motivational interviewing and Problem-solving and planning in people with Substance Dependence and HIV (Human Immunodeficiency Virus), run by Brown University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Dependence, HIV (Human Immunodeficiency Virus)
- What is being tested?
- HIV and PrEP education, Motivational interviewing and Problem-solving and planning
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Sep 2021to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- HIV-uninfected (verified by rapid/4th generation test)
- Reporting past-month injection of any drugs
- One or more HIV risk behaviors (past-month receptive syringe sharing, transactional sex, or condomless sex with an HIV-infected or unknown-status partner)
- Not currently on and never taken PrEP
- Able to understand and speak English or Spanish
Who cannot join
- Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of enrollment
- Living in Massachusetts (MA) for <3 months
- Planning to move out of MA within a year
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AIDS Action
Cambridge, Massachusetts, 02139
Greater Lawrence Family Health Center
Lawrence, Massachusetts, 01841
About this study
Official title: Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast
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.
Read the detailed description
The overall goal of this proposal is to evaluate the efficacy of the "PrEP for Health" navigator delivered behavioral intervention in improving 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) among PWID in SSPs. Eligible PWID (n=200 total; 100 recruited from each study site) will be equally randomized to an active PrEP for Health intervention arm (n=100) or a Standard of Care control condition (n=100). Assessments will be conducted at baseline and 1, 3, 6, and 12 months after randomization.
We hypothesize that brief, multi-component behavioral intervention sessions with ongoing support delivered by trained PrEP Navigators within Syringe Service Programs (SSPs) will improve PrEP uptake, adherence, and long-term adherence in PWID by increasing HIV and PrEP knowledge (including alleviating concerns about side effects), increasing HIV risk perceptions and PrEP interest and motivation, improving PrEP use self-efficacy and behavioral skills, and reducing structural barriers over time. Based on our formative research, we also hypothesize that the strength of intervention effects may differ by key individual characteristics (age, gender, baseline sexual risk, polysubstance, and stimulant use).
This is a randomized control trial (RCT). Participants will be recruited via outreach specialist at SSP sites and during routine community outreach practices of the organizations. After eligibility confirmation and baseline assessments, participants will be randomized to one of two study arms: 1) Standard of Care (SOC) Control Condition: as routinely provided through the SSP study sites, participants will receive information and services according to routine practice and a brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission; 2) "PrEP for Health" Intervention Condition: a trained PrEP Navigator will deliver a manualized PrEP uptake and adherence intervention in private counseling rooms at SSPs followed by 3 months of additional PrEP navigation support through in-person, phone, and text interactions as needed. Participants will complete a total of four follow-up visits over a 12-month period. Participants who initiate PrEP will have a hair sample collected at 3-, 6-, and 12-month visits. All participants will receive a rapid HIV screening test at 12-month follow-up.
- Being tested
- HIV and PrEP education, Motivational interviewing, Problem-solving and planning, Patient navigation, PrEP information
- Keywords
- PrEP (pre-exposure prophylaxis ), PWID (people who inject drugs), SSP (syringe service program), HIV education, Motivational interviewing, Self efficacy, Social cognitive theory
- Medical subject headings
- Substance-Related Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV and PrEP educationOther
Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.
Motivational interviewingBehavioural
Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.
Problem-solving and planningBehavioural
Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.
Patient navigationBehavioural
Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites
PrEP informationOther
A brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.
ReferralsOther
Study staff will provide basic information about PrEP and referrals to PrEP clinicians.
| Study group | Role | What they receive |
|---|---|---|
| PrEP for health | Experimental | Participants in the PrEP (pre-exposure prophylaxis) for health arm will receive theory informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation. Receives: Other: HIV and PrEP education; Behavioral: Motivational interviewing; Behavioral: Problem-solving and planning; Behavioral: Patient navigation; Other: PrEP information |
| Standard of care | Active comparator | Participants in the standard of care arm will receive PrEP information and referrals. Receives: Other: PrEP information; Other: Referrals |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP uptake
PrEP uptake will be assessed via medical/pharmacy records
Measured: 3 months
Post-treatment PrEP adherence
PrEP adherence will be assessed by drug levels in hair samples at the acute follow up time point (3 months post-baseline)
Measured: 3 months
Secondary outcomes (1)
Longer-term PrEP adherence
Longer-term PrEP adherence will be assessed by drug levels in hair samples at 6 and 12-month post-baseline
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start2 Sep 2021
- Primary completion16 Jun 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance DependenceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Fenway Institute, AIDS Action Committee of Massachusetts, Greater Lawrence Family Health Center, University of California, San Diego, Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor
- Investigators
- Katie Biello, PhD, MPH, Principal investigator, Brown UniversityAngela Bazzi, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430257
- Sponsor's protocol ID
- 2011002841
- Other IDs
- R01DA051849-01
- Acronym
- PrEP
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By request to the study investigators
Publications
Bazzi AR, Bordeu M, Baumgartner K, Sproesser DM, Bositis CM, Krakower DS, Mimiaga MJ, Biello KB. Study protocol for an efficacy trial of the "PrEP for Health" intervention to increase HIV PrEP use among people who inject drugs. BMC Public Health. 2023 Mar 17;23(1):513. doi: 10.1186/s12889-023-15429-w.
PubMed 36932369
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast
- ClinicalTrials.gov ID
- NCT04430257
- Acronym / sponsor ID
- PrEP / 2011002841
- Keywords
- PrEP (pre-exposure prophylaxis ), PWID (people who inject drugs), SSP (syringe service program), HIV education, Motivational interviewing, Self efficacy, Social cognitive theory
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Fenway Institute, AIDS Action Committee of Massachusetts, Greater Lawrence Family Health Center, University of California, San Diego, Beth Israel Deaconess Medical Center
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Jun 2020 (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.
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.
Detailed description
The overall goal of this proposal is to evaluate the efficacy of the "PrEP for Health" navigator delivered behavioral intervention in improving 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) among PWID in SSPs. Eligible PWID (n=200 total; 100 recruited from each study site) will be equally randomized to an active PrEP for Health intervention arm (n=100) or a Standard of Care control condition (n=100). Assessments will be conducted at baseline and 1, 3, 6, and 12 months after randomization.
We hypothesize that brief, multi-component behavioral intervention sessions with ongoing support delivered by trained PrEP Navigators within Syringe Service Programs (SSPs) will improve PrEP uptake, adherence, and long-term adherence in PWID by increasing HIV and PrEP knowledge (including alleviating concerns about side effects), increasing HIV risk perceptions and PrEP interest and motivation, improving PrEP use self-efficacy and behavioral skills, and reducing structural barriers over time. Based on our formative research, we also hypothesize that the strength of intervention effects may differ by key individual characteristics (age, gender, baseline sexual risk, polysubstance, and stimulant use).
This is a randomized control trial (RCT). Participants will be recruited via outreach specialist at SSP sites and during routine community outreach practices of the organizations. After eligibility confirmation and baseline assessments, participants will be randomized to one of two study arms: 1) Standard of Care (SOC) Control Condition: as routinely provided through the SSP study sites, participants will receive information and services according to routine practice and a brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission; 2) "PrEP for Health" Intervention Condition: a trained PrEP Navigator will deliver a manualized PrEP uptake and adherence intervention in private counseling rooms at SSPs followed by 3 months of additional PrEP navigation support through in-person, phone, and text interactions as needed. Participants will complete a total of four follow-up visits over a 12-month period. Participants who initiate PrEP will have a hair sample collected at 3-, 6-, and 12-month visits. All participants will receive a rapid HIV screening test at 12-month follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEP for health | Experimental | Other: HIV and PrEP education, Behavioral: Motivational interviewing, Behavioral: Problem-solving and planning, Behavioral: Patient navigation, Other: PrEP informationParticipants in the PrEP (pre-exposure prophylaxis) for health arm will receive theory informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation. |
| Standard of care | Active comparator | Other: PrEP information, Other: ReferralsParticipants in the standard of care arm will receive PrEP information and referrals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-uninfected (verified by rapid/4th generation test)
- Reporting past-month injection of any drugs
- One or more HIV risk behaviors (past-month receptive syringe sharing, transactional sex, or condomless sex with an HIV-infected or unknown-status partner)
- Not currently on and never taken PrEP
- Able to understand and speak English or Spanish
Key exclusion criteria (3 listed)
- Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of enrollment
- Living in Massachusetts (MA) for <3 months
- Planning to move out of MA within a year
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 |
|---|---|---|
| HIV and PrEP educationNavigators will deliver Social Cognitive Theory-informed HIV and PrEP education. | Other | PrEP for health |
| Motivational interviewingBachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention. | Behavioural | PrEP for health |
| Problem-solving and planningBachelors-level PrEP Navigators will assist participants with problem-solving and planning. | Behavioural | PrEP for health |
| Patient navigationOngoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites | Behavioural | PrEP for health |
| PrEP informationA brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants. | Other | PrEP for health, Standard of care |
| ReferralsStudy staff will provide basic information about PrEP and referrals to PrEP clinicians. | Other | Standard of care |
Primary outcome
PrEP uptake
Time frame: 3 months
PrEP uptake will be assessed via medical/pharmacy records
Post-treatment PrEP adherence
Time frame: 3 months
PrEP adherence will be assessed by drug levels in hair samples at the acute follow up time point (3 months post-baseline)
1 secondary outcome
Longer-term PrEP adherence
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 36932369Bazzi AR, Bordeu M, Baumgartner K, Sproesser DM, Bositis CM, Krakower DS, Mimiaga MJ, Biello KB. Study protocol for an efficacy trial of the "PrEP for Health" intervention to increase HIV PrEP use among people who inject drugs. BMC Public Health. 2023 Mar 17;23(1):513. doi: 10.1186/s12889-023-15429-w.
- Individual participant dataSharing planned: Yes. By request to the study investigators
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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.
Katie Biello, PhD, MPH principal investigator
Brown University
Angela Bazzi, PhD, MPH principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV and PrEP education, Motivational interviewing and Problem-solving and planning in people with Substance Dependence and HIV (Human Immunodeficiency Virus), run by Brown University at 2 sites in United States.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04430257, which also lists 1 linked publication.
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 13 Oct 2026.