Drug UseNCT05528562
Pre-exposure Prophylaxis (PrEP) Rapid Access
A study testing PrEP Rapid Access, HIV self-testing and Dried blood spot testing in people with Drug Use and Pre-exposure Prophylaxis (PrEP), run by Boston Medical Center at 1 site in United States.
Trial summary
The goal of phase 1 is to determine the feasibility and acceptability of an intervention ('Rapid PrEP Access') providing people who use drugs (PWUD) one-time access to HIV self-testing at the Victory Program. Aim 1: To offer HIV self-testing to PWUD in the community through a study called 'Rapid PrEP Access'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Use, Pre-exposure Prophylaxis (PrEP), Opioid Use Disorder
- What is being tested?
- PrEP Rapid Access, HIV self-testing and Dried blood spot testing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to 28 Jun 2023
- 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
- English speaking
- Opioid use that was not prescribed by a health professional in the past 6 months
Who cannot join
- Pregnant women
- Persons with previous HIV diagnosis
- Individuals currently taking PrEP
- Individuals who express desire to harm themselves or others
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PrEP Rapid Access: An Open Pilot Study- Phase 1
The goal of phase 1 is to determine the feasibility and acceptability of an intervention ('Rapid PrEP Access') providing people who use drugs (PWUD) one-time access to HIV self-testing at the Victory Program.
Aim 1: To offer HIV self-testing to PWUD in the community through a study called 'Rapid PrEP Access'. The study will be carried out at the Victory Program.
Aim 2: To determine the feasibility and acceptability of 'Rapid PrEP Access' at the Victory Program.
Read the detailed description
For phase 1 of the study, participants will be recruited for a one-time baseline interview and HIV self-testing. A questionnaire will also be administered to assess their interest in the HIV prevention pill (PrEP= pre-exposure prophylaxis), but PrEP will not be offered. Study duration for each participant is one day; participants will not be followed over time.
After the prescreener and consent forms are completed, the Research Assistant (RA) will offer the participant an opportunity to administer an HIV self-test. The participant will be provided the test for unboxing and retrieving the user instructions.
All testing will be performed and interpreted by participants. The RA can provide assistance with reading the instruction on how to obtain a proper sample. Alternatively, the RA will direct them to information in the package insert which includes support offered by the OraQuick® Support Center.
After completing the HIVST, the RA will complete the baseline questionnaire with each participant while waiting for the participants' HIVST results. After the baseline questionnaire is complete, the RA will conduct satisfaction surveys to assess acceptability of the intervention and interest of PrEP initiation using REDCap.
- Being tested
- PrEP Rapid Access, HIV self-testing, Dried blood spot testing
- Keywords
- People who inject drugs (PWID), Rapid PrEP Access, Substance use, Mobile health van
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP Rapid AccessOther
'Rapid PrEP Access' is a low-threshold intervention designed to provide on-site access to HIV self-testing at the Victory Program for persons who use opioids.
HIV self-testingOther
After enrollment the research assistant (RA) will provide the participant with a HIV self-test and provide instructions on how to obtain a proper sample for the test. It uses an oral fluid test and yields results within 20 minutes.
Dried blood spot testingOther
HIV Dried blood spot (DBS) testing provides an accurate method of measuring the HIV viral load in comparison to plasma viral load.
| Study group | Role | What they receive |
|---|---|---|
| PrEP Rapid Access | Experimental | Participants who are at risk of HIV and being seen at the Victory Program's Mobile Prevention Services Van. Receives: Other: PrEP Rapid Access; Other: HIV self-testing; Other: Dried blood spot testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants enrolled
Feasibility will be assessed by the number of participants enrolled
Measured: 12 months
Acceptability of PrEP rapid Access
Participants will rate PrEP Rapid Access' acceptability using an investigator-developed scale ranging from 1 to 5 where 1= not acceptable and 5 is very acceptable.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Number of participants who perform HIV self-test
This information will be obtained from information recorded on the day of recruitment for the study.
Measured: Through study completion, an average of 1 year
Number of participants interested in initiating PrEP
This information will be obtained from information recorded on the day of recruitment from the survey data.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start12 Apr 2023
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
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 Drug UseStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Victory Programs
- Responsible party
- Sponsor
- Investigators
- Sabrina Assoumou, MD MPH, Principal investigator, Boston Medical Center, Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528562
- Sponsor's protocol ID
- H-43090
- Status last verified
- Jul 2024
- First submitted
- 1 Sep 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Assoumou SA, Bonilla HV, Ruiz-Mercado G, Von Lossnitzer M, Baker R, Crawford ND, Bernstein JA. Community-based HIV Self-testing for Persons Who Use Drugs Can Contribute to Reaching Ending the HIV Epidemic in the US (EHE) Goals. Open Forum Infect Dis. 2024 Jun 17;11(6):ofae189. doi: 10.1093/ofid/ofae189. eCollection 2024 Jun.
PubMed 38887480
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP Rapid Access: An Open Pilot Study- Phase 1
- ClinicalTrials.gov ID
- NCT05528562
- Acronym / sponsor ID
- H-43090
- Keywords
- People who inject drugs (PWID), Rapid PrEP Access, Substance use, Mobile health van
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Victory Programs
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 6 Sep 2022 (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.
The goal of phase 1 is to determine the feasibility and acceptability of an intervention ('Rapid PrEP Access') providing people who use drugs (PWUD) one-time access to HIV self-testing at the Victory Program.
Aim 1: To offer HIV self-testing to PWUD in the community through a study called 'Rapid PrEP Access'. The study will be carried out at the Victory Program.
Aim 2: To determine the feasibility and acceptability of 'Rapid PrEP Access' at the Victory Program.
Detailed description
For phase 1 of the study, participants will be recruited for a one-time baseline interview and HIV self-testing. A questionnaire will also be administered to assess their interest in the HIV prevention pill (PrEP= pre-exposure prophylaxis), but PrEP will not be offered. Study duration for each participant is one day; participants will not be followed over time.
After the prescreener and consent forms are completed, the Research Assistant (RA) will offer the participant an opportunity to administer an HIV self-test. The participant will be provided the test for unboxing and retrieving the user instructions.
All testing will be performed and interpreted by participants. The RA can provide assistance with reading the instruction on how to obtain a proper sample. Alternatively, the RA will direct them to information in the package insert which includes support offered by the OraQuick® Support Center.
After completing the HIVST, the RA will complete the baseline questionnaire with each participant while waiting for the participants' HIVST results. After the baseline questionnaire is complete, the RA will conduct satisfaction surveys to assess acceptability of the intervention and interest of PrEP initiation using REDCap.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrEP Rapid Access | Experimental | Other: PrEP Rapid Access, Other: HIV self-testing, Other: Dried blood spot testingParticipants who are at risk of HIV and being seen at the Victory Program's Mobile Prevention Services Van. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking
- Opioid use that was not prescribed by a health professional in the past 6 months
Key exclusion criteria (4 listed)
- Pregnant women
- Persons with previous HIV diagnosis
- Individuals currently taking PrEP
- Individuals who express desire to harm themselves or others
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 Rapid Access'Rapid PrEP Access' is a low-threshold intervention designed to provide on-site access to HIV self-testing at the Victory Program for persons who use opioids. | Other | PrEP Rapid Access |
| HIV self-testingAfter enrollment the research assistant (RA) will provide the participant with a HIV self-test and provide instructions on how to obtain a proper sample for the test. It uses an oral fluid test and yields results within 20 minutes. | Other | PrEP Rapid Access |
| Dried blood spot testingHIV Dried blood spot (DBS) testing provides an accurate method of measuring the HIV viral load in comparison to plasma viral load. | Other | PrEP Rapid Access |
Primary outcome
Number of participants enrolled
Time frame: 12 months
Feasibility will be assessed by the number of participants enrolled
Acceptability of PrEP rapid Access
Time frame: Through study completion, an average of 1 year
Participants will rate PrEP Rapid Access' acceptability using an investigator-developed scale ranging from 1 to 5 where 1= not acceptable and 5 is very acceptable.
2 secondary outcomes
Number of participants who perform HIV self-test
Time frame: Through study completion, an average of 1 year
Number of participants interested in initiating PrEP
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Derived from this study: PubMed 38887480Assoumou SA, Bonilla HV, Ruiz-Mercado G, Von Lossnitzer M, Baker R, Crawford ND, Bernstein JA. Community-based HIV Self-testing for Persons Who Use Drugs Can Contribute to Reaching Ending the HIV Epidemic in the US (EHE) Goals. Open Forum Infect Dis. 2024 Jun 17;11(6):ofae189. doi: 10.1093/ofid/ofae189. eCollection 2024 Jun.
- Individual participant dataSharing planned: No
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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.
Sabrina Assoumou, MD MPH principal investigator
Boston Medical Center, Infectious Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP Rapid Access, HIV self-testing and Dried blood spot testing in people with Drug Use and Pre-exposure Prophylaxis (PrEP), run by Boston Medical Center at 1 site 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants enrolled (time frame: 12 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 NCT05528562, 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 16 Jul 2024.