Trial Outcomes & Findings for PrEP Readiness Interventions for Supporting Motivation (NCT NCT04205487)

NCT ID: NCT04205487

Last Updated: 2025-06-29

Results Overview

The proportion of participants who provide evidence that they have filled a PrEP prescription

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

6 Months

Results posted on

2025-06-29

Participant Flow

A US national sample of sexual minority men taking pre-exposure prophylaxis (PrEP) who reported using stimulants (i.e., methamphetamine, powder cocaine, or crack-cocaine) in the past three months was recruited from social networking applications and existing consent-to-contact databases.

Participants completed a run-in period where they were asked to provide a saliva sample via mail to confirm they were not living with HIV. Those who did not provide a saliva sample or those with reactive HIV results were excluded.

Participant milestones

Participant milestones
Measure	Contingency Management (CM) - Only (Non-Responder or Lost to Follow Up During Stage 1) Participants randomized in Stage 1 to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription that were non-responders. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during Stage 1 and we not re-randomized during Stage 2.	Motivational Interviewing (MI) - Only (Non-Responder or Lost to Follow Up During Stage 1) Participants randomized in Stage 1 two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom.. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during stage 1 and were not re-randomized during Stage 2.	CM+MI Sequential delivery of CM(Stage 1) and then MI (Stage 2) for non-responders at the stage-two randomization to "switch."	MI+CM Sequential delivery of MI (Stage 1) and then CM (Stage 2) for non-responders at the stage-two randomization to "switch."	CM-Only (Responder) Responders randomized to receive CM financial incentives for PrEP clincial evaluation and uptake in Stage 1 who provided evidence of a recent PrEP prescription.	MI-Only (Responder) Responders randomized to receive two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom.
First Stage Intervention (Months 1-3) STARTED	15	21	9	7	11	7
First Stage Intervention (Months 1-3) COMPLETED	5	13	9	7	11	7
First Stage Intervention (Months 1-3) NOT COMPLETED	10	8	0	0	0	0
Second Stage Intervention (Months 4-6) STARTED	5	13	9	7	11	7
Second Stage Intervention (Months 4-6) COMPLETED	3	12	9	7	7	7
Second Stage Intervention (Months 4-6) NOT COMPLETED	2	1	0	0	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PrEP Readiness Interventions for Supporting Motivation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CM-Only (Non-Responder) n=15 Participants Participants randomized in Stage 1 to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription that were non-responders. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during Stage 1 and we not re-randomized during stage 2.	MI-Only (Non-Responder) n=21 Participants Participants randomized in Stage 1 two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during stage 1 and were not re-randomized during stage 2.	CM+MI (Non-Responder) n=9 Participants Sequential delivery of CM (Stage 1) and MI (Stage 2) for non-responders that were randomized in Stage 2 to "switch."	MI+CM (Non-Responder) n=7 Participants Sequential delivery of MI (Stage 1) and CM (Stage 2) for non-responders that were randomized in Stage 2 to "switch."	CM-Only (Responder) n=11 Participants Responders randomized to receive CM financial incentives for PrEP clinical evaluation and uptake in Stage 1 who provided evidence of a recent PrEP prescription.	MI-Only (Responder) n=7 Participants Responders randomized to receive two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom.	Total n=70 Participants Total of all reporting groups
Age, Continuous	41 Years STANDARD_DEVIATION 9 • n=5 Participants	41 Years STANDARD_DEVIATION 11 • n=7 Participants	40 Years STANDARD_DEVIATION 8 • n=5 Participants	45 Years STANDARD_DEVIATION 5 • n=4 Participants	43 Years STANDARD_DEVIATION 10 • n=21 Participants	36 Years STANDARD_DEVIATION 8 • n=8 Participants	41 Years STANDARD_DEVIATION 9 • n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	21 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	11 Participants n=21 Participants	7 Participants n=8 Participants	70 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	12 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	18 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	11 Participants n=21 Participants	5 Participants n=8 Participants	58 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	18 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants	4 Participants n=8 Participants	50 Participants n=8 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	7 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants
Region of Enrollment United States	15 Participants n=5 Participants	21 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	11 Participants n=21 Participants	7 Participants n=8 Participants	70 Participants n=8 Participants
Annual Income Less than $5,000	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	7 Participants n=8 Participants
Annual Income $5,000 - $24,999	5 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	23 Participants n=8 Participants
Annual Income $25,000 - $74,999	7 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants	4 Participants n=8 Participants	30 Participants n=8 Participants
Annual Income $75,000 - $99,000	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Annual Income $100,000 or more	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Annual Income Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: 6 Months

The proportion of participants who provide evidence that they have filled a PrEP prescription

Outcome measures

Outcome measures
Measure	CM-Only (Non-Responder or Lost to Follow Up During Stage 1) n=5 Participants Participants randomized in Stage 1 to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription that were non-responders. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during Stage 1 and we not re-randomized during stage 2.	MI-Only (Non-Responder or Lost to Follow Up During Stage 1) n=13 Participants Participants randomized in Stage 1 two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom.. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during stage 1 and were not re-randomized during stage 2.	CM+MI n=9 Participants Sequential delivery of CM (Stage 1) and MI (Stage 2) for non-responders that were randomized in Stage 2 to "switch."	MI+CM n=7 Participants Sequential delivery of MI (Stage 1) and CM (Stage 2) for non-responders that were randomized in Stage 2 to "switch."	CM-Only (Responder) n=11 Participants Randomized in Stage 1 to CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription and provided evidence of a recent PrEP prescription.	MI-Only (Responder) n=7 Participants Randomized in Stage 1 to two MI sessions focusing on stimulant use, sexual risk, and PrEP use, and provided evidence of a recent PrEP prescription.
Proportion of Participants Filling a Prescription for PrEP Yes	0 Participants	2 Participants	2 Participants	5 Participants	11 Participants	7 Participants
Proportion of Participants Filling a Prescription for PrEP No	5 Participants	11 Participants	7 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 Months

The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP.

Outcome measures

Outcome measures
Measure	CM-Only (Non-Responder or Lost to Follow Up During Stage 1) n=5 Participants Participants randomized in Stage 1 to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription that were non-responders. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during Stage 1 and we not re-randomized during stage 2.	MI-Only (Non-Responder or Lost to Follow Up During Stage 1) n=13 Participants Participants randomized in Stage 1 two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom.. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during stage 1 and were not re-randomized during stage 2.	CM+MI n=9 Participants Sequential delivery of CM (Stage 1) and MI (Stage 2) for non-responders that were randomized in Stage 2 to "switch."	MI+CM n=7 Participants Sequential delivery of MI (Stage 1) and CM (Stage 2) for non-responders that were randomized in Stage 2 to "switch."	CM-Only (Responder) n=11 Participants Randomized in Stage 1 to CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription and provided evidence of a recent PrEP prescription.	MI-Only (Responder) n=7 Participants Randomized in Stage 1 to two MI sessions focusing on stimulant use, sexual risk, and PrEP use, and provided evidence of a recent PrEP prescription.
Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider Yes	3 Participants	9 Participants	8 Participants	4 Participants	11 Participants	7 Participants
Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider No	2 Participants	4 Participants	1 Participants	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Participants will complete the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which provides validated composite scores indexing the severity of methamphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).

Outcome measures

Outcome measures
Measure	CM-Only (Non-Responder or Lost to Follow Up During Stage 1) n=3 Participants Participants randomized in Stage 1 to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription that were non-responders. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during Stage 1 and we not re-randomized during stage 2.	MI-Only (Non-Responder or Lost to Follow Up During Stage 1) n=12 Participants Participants randomized in Stage 1 two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom.. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during stage 1 and were not re-randomized during stage 2.	CM+MI n=8 Participants Sequential delivery of CM (Stage 1) and MI (Stage 2) for non-responders that were randomized in Stage 2 to "switch."	MI+CM n=5 Participants Sequential delivery of MI (Stage 1) and CM (Stage 2) for non-responders that were randomized in Stage 2 to "switch."	CM-Only (Responder) n=7 Participants Randomized in Stage 1 to CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription and provided evidence of a recent PrEP prescription.	MI-Only (Responder) n=7 Participants Randomized in Stage 1 to two MI sessions focusing on stimulant use, sexual risk, and PrEP use, and provided evidence of a recent PrEP prescription.
Clinical Cut Points for Self-reported Methamphetamine Use Severity Mild (0-3)	2 Participants	7 Participants	2 Participants	4 Participants	2 Participants	6 Participants
Clinical Cut Points for Self-reported Methamphetamine Use Severity Moderate (4-26)	1 Participants	1 Participants	6 Participants	0 Participants	3 Participants	0 Participants
Clinical Cut Points for Self-reported Methamphetamine Use Severity Severe (27 or greater)	0 Participants	4 Participants	0 Participants	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Participants will complete a detailed behavioral assessment to report the number of men with whom they have had receptive CAS. The proportion of participants reporting any receptive CAS will be reported.

Outcome measures

Outcome measures
Measure	CM-Only (Non-Responder or Lost to Follow Up During Stage 1) n=3 Participants Participants randomized in Stage 1 to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription that were non-responders. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during Stage 1 and we not re-randomized during stage 2.	MI-Only (Non-Responder or Lost to Follow Up During Stage 1) n=12 Participants Participants randomized in Stage 1 two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom.. These participants were randomized to receive assessments only in Stage 2, or were lost to follow up during stage 1 and were not re-randomized during stage 2.	CM+MI n=8 Participants Sequential delivery of CM (Stage 1) and MI (Stage 2) for non-responders that were randomized in Stage 2 to "switch."	MI+CM n=5 Participants Sequential delivery of MI (Stage 1) and CM (Stage 2) for non-responders that were randomized in Stage 2 to "switch."	CM-Only (Responder) n=7 Participants Randomized in Stage 1 to CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription and provided evidence of a recent PrEP prescription.	MI-Only (Responder) n=7 Participants Randomized in Stage 1 to two MI sessions focusing on stimulant use, sexual risk, and PrEP use, and provided evidence of a recent PrEP prescription.
Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) No	3 Participants	6 Participants	4 Participants	3 Participants	5 Participants	4 Participants
Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) Yes	0 Participants	6 Participants	4 Participants	2 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 6 months

Participants will complete a detailed behavioral assessment to report the number of men with whom they have had insertive CAS. The proportion of participants reporting any insertive CAS will be reported.