HivPhase 4NCT04782180
PrEP at a Syringe Services Program
A Phase 4 study testing Descovy 200Mg 25Mg Tablet and PrEP in people with Hiv and Substance Use Disorders, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Substance Use Disorders
- What is being tested?
- Descovy 200Mg 25Mg Tablet and PrEP
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 11 Nov 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the age of 18
- speak either English or Spanish
- ability to provide informed consent
- currently enrolled in the syringe services program
- have a negative HIV rapid test result
- estimated creatinine clearance > 30 ml/minute
Who cannot join
- do not meet the above criteria of inclusion
- decline to participate
- test positive for HIV via rapid test
- are pregnant or plan on becoming pregnant
- have symptoms acute HIV.
- Any other comorbidities that at the discretion of the investigator would prevent the participant from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Delivery of PrEP at a Syringe Services Program-A Pilot Study
The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.
- Conditions
- Hiv, Substance Use Disorders
- Being tested
- Descovy 200Mg 25Mg Tablet, PrEP
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descovy 200Mg 25Mg TabletDrug
daily Descovy tab by mouth
PrEPBehavioural
PrEP will be provided in a community setting by community-based harm reduction program.
| Study group | Role | What they receive |
|---|---|---|
| Rapid PrEP group | Experimental | Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program. Receives: Drug: Descovy 200Mg 25Mg Tablet; Behavioral: PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up
Tenofovir diphosphate levels will be quantified using a validated dried blood spot (DBS) assay. The outcome will be reported as the mean intracellular concentration (fmol/punch) at the 6-month follow-up visit. This measure reflects intracellular drug exposure and adherence.
Measured: 6 months
Secondary outcomes (1)
Time to PrEP Initiation Post Negative HIV Rapid Test
Number of days between receiving negative test result and initiating PrEP via self-report
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Feb 2022
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HivStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Hansel Tookes, University of Miami
- Investigators
- Hansel Tookes, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782180
- Sponsor's protocol ID
- 20210017
- Status last verified
- Dec 2025
- First submitted
- 1 Mar 2021
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Delivery of PrEP at a Syringe Services Program-A Pilot Study
- ClinicalTrials.gov ID
- NCT04782180
- Acronym / sponsor ID
- 20210017
- Conditions
- Hiv, Substance Use Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Posted 19 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid PrEP group | Experimental | Drug: Descovy 200Mg 25Mg Tablet, Behavioral: PrEPParticipants will receive PrEP i.e. Descovy for 12 months at the syringe services program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- over the age of 18
- speak either English or Spanish
- ability to provide informed consent
- currently enrolled in the syringe services program
- have a negative HIV rapid test result
Key exclusion criteria (6 listed)
- do not meet the above criteria of inclusion
- decline to participate
- test positive for HIV via rapid test
- are pregnant or plan on becoming pregnant
- have symptoms acute HIV.
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 |
|---|---|---|
| Descovy 200Mg 25Mg Tabletdaily Descovy tab by mouth | Drug | Rapid PrEP group |
| PrEPPrEP will be provided in a community setting by community-based harm reduction program. | Behavioural | Rapid PrEP group |
Primary outcome
Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up
Time frame: 6 months
Tenofovir diphosphate levels will be quantified using a validated dried blood spot (DBS) assay. The outcome will be reported as the mean intracellular concentration (fmol/punch) at the 6-month follow-up visit. This measure reflects intracellular drug exposure and adherence.
1 secondary outcome
Time to PrEP Initiation Post Negative HIV Rapid Test
Time frame: up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Hansel Tookes principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Descovy 200Mg 25Mg Tablet and PrEP in people with Hiv and Substance Use Disorders, run by University of Miami 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 6 inclusion and 6 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 19 Dec 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up (time frame: 6 months). 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 19 Dec 2025.