A Phase 4 interventional study of Descovy 200Mg 25Mg Tablet and PrEP in Hiv and Substance Use Disorders, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by University of Miami · Phase 4, Interventional, and Prevention
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 90 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program.
Drug: Descovy 200Mg 25Mg Tablet · Behavioral: PrEP
daily Descovy tab by mouth
PrEP will be provided in a community setting by community-based harm reduction program.
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.
Time frame: 6 months
Time to PrEP Initiation Post Negative HIV Rapid Test
Number of days between receiving negative test result and initiating PrEP via self-report
Time frame: up to 12 months
| Milestone | Rapid PrEP Group |
|---|---|
| Started | 90 |
| Completed | 86 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 2 |
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.
| fmol/punch | Rapid PrEP group |
|---|---|
| Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up | NA |
Number of days between receiving negative test result and initiating PrEP via self-report
| days | Rapid PrEP group |
|---|---|
| Time to PrEP Initiation Post Negative HIV Rapid Test | 0 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rapid PrEP Group | 0/90 (0%) | 0/90 (0%) | 0/90 (0%) |
| Age, Categorical(Participants) | Rapid PrEP Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 86 |
| >=65 years | 4 |
| Sex: Female, Male(Participants) | Rapid PrEP Group |
|---|---|
| Female | 27 |
| Male | 59 |
| Ethnicity (NIH/OMB)(Participants) | Rapid PrEP Group |
|---|---|
| Hispanic or Latino | 38 |
| Not Hispanic or Latino | 48 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Rapid PrEP Group |
|---|---|
| American Indian or Alaska Native | 3 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 11 |
| White | 64 |
| More than one race | 7 |
| Unknown or Not Reported | 4 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
University of Miami