Hiv, Substance Use Disorders
Conditions
Brief 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.
Interventions
DRUGDescovy 200Mg 25Mg Tablet
daily Descovy tab by mouth
BEHAVIORALPrEP
PrEP will be provided in a community setting by community-based harm reduction program.
Sponsors
Gilead Sciences
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. over the age of 18 2. speak either English or Spanish 3. ability to provide informed consent 4. currently enrolled in the syringe services program 5. have a negative HIV rapid test result 6. estimated creatinine clearance \> 30 ml/minute
Exclusion criteria
1. do not meet the above criteria of inclusion 2. decline to participate 3. test positive for HIV via rapid test 4. are pregnant or plan on becoming pregnant 5. have symptoms acute HIV. 6. Any other comorbidities that at the discretion of the investigator would prevent the participant from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to PrEP Initiation Post Negative HIV Rapid Test | up to 12 months | Number of days between receiving negative test result and initiating PrEP via self-report |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rapid PrEP Group Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program.
Descovy 200Mg 25Mg Tablet: daily Descovy tab by mouth
PrEP: PrEP will be provided in a community setting by community-based harm reduction program. | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Rapid PrEP Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 90 |
| other Total, other adverse events | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
Primary
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
Population: Specimens were collected but none met laboratory acceptance criteria (insufficient punch volume and degradation). Therefore, no valid concentrations could be calculated. All values are reported as Not Analyzable.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rapid PrEP group | Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up | NA fmol/punch |
Secondary
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
Population: All participants-initiated PrEP immediately following their negative test result. Because initiation occurred on the same day as the negative test (day 0), the calculated value for every participant was zero days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rapid PrEP group | Time to PrEP Initiation Post Negative HIV Rapid Test | 0 days |