Trial Outcomes & Findings for PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men (NCT NCT05353283)

NCT ID: NCT05353283

Last Updated: 2026-02-13

Results Overview

Number of participants reporting the intervention to be "somewhat" or "very" acceptable on a five-point Likert scale

Recruitment status

COMPLETED

Study phase

Target enrollment

63 participants

Primary outcome timeframe

3 months

Results posted on

2026-02-13

Participant Flow

Participants were recruited via targeted advertisements on a geospatial social mobile application.

63 participants were enrolled and randomized.

Participant milestones

Participant milestones
Measure	Intervention Arm POC adherence testing by a urine tenofovir assay with motivational interviewing counselling	Standard of Care Adherence counselling provided by the participant's PrEP care provider
Overall Study STARTED	42	21
Overall Study COMPLETED	41	21
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Arm POC adherence testing by a urine tenofovir assay with motivational interviewing counselling	Standard of Care Adherence counselling provided by the participant's PrEP care provider
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=40 Participants POC adherence testing by a urine tenofovir assay with motivational interviewing counselling	Standard of Care n=20 Participants Adherence counselling provided by the participant's PrEP care provider	Total n=60 Participants Total of all reporting groups
Sex: Female, Male Female	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Sex: Female, Male Male	40 Participants n=41 Participants	20 Participants n=1581 Participants	60 Participants n=4626 Participants
Age, Continuous	26.8 Years STANDARD_DEVIATION 2.6 • n=41 Participants	26.1 Years STANDARD_DEVIATION 2.7 • n=1581 Participants	26.6 Years STANDARD_DEVIATION 2.6 • n=4626 Participants
Daily PrEP Regimen Descovy (FTC/TAF)	20 Participants n=41 Participants	8 Participants n=1581 Participants	28 Participants n=4626 Participants
Daily PrEP Regimen Truvada (FTC/TDF)	20 Participants n=41 Participants	12 Participants n=1581 Participants	32 Participants n=4626 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=41 Participants	0 Participants n=1581 Participants	1 Participants n=4626 Participants
Race (NIH/OMB) Asian	8 Participants n=41 Participants	2 Participants n=1581 Participants	10 Participants n=4626 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) Black or African American	2 Participants n=41 Participants	3 Participants n=1581 Participants	5 Participants n=4626 Participants
Race (NIH/OMB) White	23 Participants n=41 Participants	10 Participants n=1581 Participants	33 Participants n=4626 Participants
Race (NIH/OMB) More than one race	6 Participants n=41 Participants	5 Participants n=1581 Participants	11 Participants n=4626 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=41 Participants	7 Participants n=1581 Participants	21 Participants n=4626 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=41 Participants	13 Participants n=1581 Participants	39 Participants n=4626 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants

PRIMARY outcome

Timeframe: 3 months

Population: One participant did not complete the study and was lost to follow-up. One participant was excluded from analysis due to inadequate hair samples.

Number of participants reporting the intervention to be "somewhat" or "very" acceptable on a five-point Likert scale

Outcome measures

Outcome measures
Measure	Intervention Arm n=40 Participants POC adherence testing by a urine tenofovir assay with motivational interviewing counselling	Standard of Care Adherence counselling provided by the participant's PrEP care provider
Number of Participants Indicating the Intervention Was Acceptable	37 Participants	—

SECONDARY outcome

Timeframe: 3 months

Population: One participant from the intervention arm did not complete the study and was lost to follow-up. One participant from the intervention arm and one participant from the standard of care arm were excluded from analysis due to inadequate hair samples.

Measure change in tenofovir levels in hair samples from baseline to 3 months using liquid chromatography-mass spectrometry assays.

Outcome measures

Outcome measures
Measure	Intervention Arm n=40 Participants POC adherence testing by a urine tenofovir assay with motivational interviewing counselling	Standard of Care n=20 Participants Adherence counselling provided by the participant's PrEP care provider
Long-term Adherence Outcomes Baseline tenofovir concentrations in hair	0.036 ng/mg Standard Error 0.003	0.04 ng/mg Standard Error 0.006
Long-term Adherence Outcomes 3-month follow-up tenofovir concentrations in hair	0.046 ng/mg Standard Error 0.0033	0.037 ng/mg Standard Error 0.0056

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

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

Matthew Spinelli

University of California, San Francisco

Phone: 415-476-4082

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place