Trial Outcomes & Findings for PrEP at a Syringe Services Program (NCT NCT04782180)

Last Updated: 2025-12-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

90 participants

Primary outcome timeframe

6 months

Results posted on

2025-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	90
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

4 participants consented and left before data was collected for baseline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rapid PrEP Group n=90 Participants 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.
Age, Categorical <=18 years	0 Participants n=90 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=90 Participants
Age, Categorical >=65 years	4 Participants n=90 Participants
Sex: Female, Male Female	27 Participants n=86 Participants • 4 participants consented and left before data was collected for baseline
Sex: Female, Male Male	59 Participants n=86 Participants • 4 participants consented and left before data was collected for baseline
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants n=86 Participants • 4 participants consented and left before data was collected for baseline
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=86 Participants • 4 participants consented and left before data was collected for baseline
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=86 Participants • 4 participants consented and left before data was collected for baseline
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=90 Participants
Race (NIH/OMB) Asian	1 Participants n=90 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=90 Participants
Race (NIH/OMB) Black or African American	11 Participants n=90 Participants
Race (NIH/OMB) White	64 Participants n=90 Participants
Race (NIH/OMB) More than one race	7 Participants n=90 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=90 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Rapid PrEP group n=86 Participants 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.
Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up	NA fmol/punch No valid concentrations could be calculated because specimens failed laboratory acceptance criteria. Not applicable; no analyzable data are available

SECONDARY outcome

Timeframe: 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

Number of days between receiving negative test result and initiating PrEP via self-report

Outcome measures

Outcome measures
Measure	Rapid PrEP group n=86 Participants 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.
Time to PrEP Initiation Post Negative HIV Rapid Test	0 days

Adverse Events

Rapid PrEP Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hansel Tookes, Professor of Medicine

University of Miami

Phone: 305-689-7030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place