HIV Infections, Pre-exposure Prophylaxis, Substance Use Disorders
Conditions
Brief summary
The overarching goal of this formative research is to examine whether, and in what combination, contingency management (CM) and motivational interviewing (MI) can facilitate entry of stimulant-using men who have sex with men (MSM) into the pre-exposure prophylaxis (PrEP) care continuum.
Detailed description
In Stage 1, participants will be randomized to receive either: 1) three months of CM; or 2) two sessions of MI. All participants will be assessed at three months post-randomization for non-response. In Stage 2, a second randomization where non-responders (i.e., those who have not filled a PrEP prescription) are assigned to: 1) Switch to sequentially receive the other intervention (i.e., CM+MI or MI+CM); or 2) Continue with assessments only (i.e., CM-Only or MI-Only). All participants will complete a final assessment at 6 months.
Interventions
BEHAVIORALMotivational Interviewing (MI)
Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.
BEHAVIORALContingency Management (CM)
CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.
Sponsors
City University of New York
National Institute on Drug Abuse (NIDA)
Florida International University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Sequential Multiple Assignment Randomized Trial (SMART)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years of age * Sexually active cisgender sexual minority man * Reports using stimulants in the past three months * HIV-negative serostatus * Meets Centers for Disease Control and Prevention (CDC) criteria for PrEP eligibility
Exclusion criteria
* Currently prescribed PrEP * Unable to provide informed consent * Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Filling a Prescription for PrEP | 6 Months | The proportion of participants who provide evidence that they have filled a PrEP prescription |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | 6 Months | The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP. |
| Clinical Cut Points for Self-reported Methamphetamine Use Severity | 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). |
| Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | 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. |
| Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| CM-Only (Non-Responder) 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. | 15 |
| MI-Only (Non-Responder) 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. | 21 |
| CM+MI (Non-Responder) Sequential delivery of CM (Stage 1) and MI (Stage 2) for non-responders that were randomized in Stage 2 to switch. | 9 |
| MI+CM (Non-Responder) Sequential delivery of MI (Stage 1) and CM (Stage 2) for non-responders that were randomized in Stage 2 to switch. | 7 |
| CM-Only (Responder) Responders randomized to receive CM financial incentives for PrEP clinical evaluation and uptake in Stage 1 who provided evidence of a recent PrEP prescription. | 11 |
| MI-Only (Responder) Responders randomized to receive two MI sessions focusing on stimulant use, sexual risk, and PrEP uptake delivered via Zoom. | 7 |
| Total | 70 |
Baseline characteristics
| Characteristic | MI-Only (Non-Responder) | CM-Only (Non-Responder) | Total | MI-Only (Responder) | CM-Only (Responder) | MI+CM (Non-Responder) | CM+MI (Non-Responder) |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 41 Years STANDARD_DEVIATION 11 | 41 Years STANDARD_DEVIATION 9 | 41 Years STANDARD_DEVIATION 9 | 36 Years STANDARD_DEVIATION 8 | 43 Years STANDARD_DEVIATION 10 | 45 Years STANDARD_DEVIATION 5 | 40 Years STANDARD_DEVIATION 8 |
| Annual Income $100,000 or more | 2 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Annual Income $25,000 - $74,999 | 6 Participants | 7 Participants | 30 Participants | 4 Participants | 7 Participants | 2 Participants | 4 Participants |
| Annual Income $5,000 - $24,999 | 7 Participants | 5 Participants | 23 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants |
| Annual Income $75,000 - $99,000 | 2 Participants | 0 Participants | 6 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants |
| Annual Income Less than $5,000 | 4 Participants | 1 Participants | 7 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Annual Income Unknown | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 12 Participants | 2 Participants | 0 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 14 Participants | 58 Participants | 5 Participants | 11 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 6 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 7 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 10 Participants | 50 Participants | 4 Participants | 7 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 21 Participants | 15 Participants | 70 Participants | 7 Participants | 11 Participants | 7 Participants | 9 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 21 Participants | 15 Participants | 70 Participants | 7 Participants | 11 Participants | 7 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 21 | 0 / 9 | 0 / 7 | 0 / 11 | 0 / 7 |
| other Total, other adverse events | 0 / 15 | 0 / 21 | 0 / 9 | 0 / 7 | 0 / 11 | 0 / 7 |
| serious Total, serious adverse events | 0 / 15 | 0 / 21 | 0 / 9 | 0 / 7 | 0 / 11 | 0 / 7 |
Outcome results
Primary
Proportion of Participants Filling a Prescription for PrEP
The proportion of participants who provide evidence that they have filled a PrEP prescription
Time frame: 6 Months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CM-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Filling a Prescription for PrEP | No | 5 Participants |
| CM-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Filling a Prescription for PrEP | Yes | 0 Participants |
| MI-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Filling a Prescription for PrEP | No | 11 Participants |
| MI-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Filling a Prescription for PrEP | Yes | 2 Participants |
| CM+MI | Proportion of Participants Filling a Prescription for PrEP | No | 7 Participants |
| CM+MI | Proportion of Participants Filling a Prescription for PrEP | Yes | 2 Participants |
| MI+CM | Proportion of Participants Filling a Prescription for PrEP | No | 2 Participants |
| MI+CM | Proportion of Participants Filling a Prescription for PrEP | Yes | 5 Participants |
| CM-Only (Responder) | Proportion of Participants Filling a Prescription for PrEP | Yes | 11 Participants |
| CM-Only (Responder) | Proportion of Participants Filling a Prescription for PrEP | No | 0 Participants |
| MI-Only (Responder) | Proportion of Participants Filling a Prescription for PrEP | Yes | 7 Participants |
| MI-Only (Responder) | Proportion of Participants Filling a Prescription for PrEP | No | 0 Participants |
Secondary
Clinical Cut Points for Self-reported Methamphetamine Use Severity
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).
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CM-Only (Non-Responder or Lost to Follow Up During Stage 1) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Moderate (4-26) | 1 Participants |
| CM-Only (Non-Responder or Lost to Follow Up During Stage 1) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Severe (27 or greater) | 0 Participants |
| CM-Only (Non-Responder or Lost to Follow Up During Stage 1) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Mild (0-3) | 2 Participants |
| MI-Only (Non-Responder or Lost to Follow Up During Stage 1) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Mild (0-3) | 7 Participants |
| MI-Only (Non-Responder or Lost to Follow Up During Stage 1) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Severe (27 or greater) | 4 Participants |
| MI-Only (Non-Responder or Lost to Follow Up During Stage 1) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Moderate (4-26) | 1 Participants |
| CM+MI | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Severe (27 or greater) | 0 Participants |
| CM+MI | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Mild (0-3) | 2 Participants |
| CM+MI | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Moderate (4-26) | 6 Participants |
| MI+CM | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Mild (0-3) | 4 Participants |
| MI+CM | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Severe (27 or greater) | 1 Participants |
| MI+CM | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Moderate (4-26) | 0 Participants |
| CM-Only (Responder) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Moderate (4-26) | 3 Participants |
| CM-Only (Responder) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Severe (27 or greater) | 2 Participants |
| CM-Only (Responder) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Mild (0-3) | 2 Participants |
| MI-Only (Responder) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Severe (27 or greater) | 1 Participants |
| MI-Only (Responder) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Mild (0-3) | 6 Participants |
| MI-Only (Responder) | Clinical Cut Points for Self-reported Methamphetamine Use Severity | Moderate (4-26) | 0 Participants |
Secondary
Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS)
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CM-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | Yes | 2 Participants |
| CM-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | No | 1 Participants |
| MI-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | Yes | 6 Participants |
| MI-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | No | 6 Participants |
| CM+MI | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | Yes | 4 Participants |
| CM+MI | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | No | 4 Participants |
| MI+CM | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | Yes | 2 Participants |
| MI+CM | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | No | 3 Participants |
| CM-Only (Responder) | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | Yes | 5 Participants |
| CM-Only (Responder) | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | No | 2 Participants |
| MI-Only (Responder) | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | Yes | 6 Participants |
| MI-Only (Responder) | Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS) | No | 1 Participants |
Secondary
Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS)
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CM-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | Yes | 0 Participants |
| CM-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | No | 3 Participants |
| MI-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | Yes | 6 Participants |
| MI-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | No | 6 Participants |
| CM+MI | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | Yes | 4 Participants |
| CM+MI | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | No | 4 Participants |
| MI+CM | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | Yes | 2 Participants |
| MI+CM | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | No | 3 Participants |
| CM-Only (Responder) | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | Yes | 2 Participants |
| CM-Only (Responder) | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | No | 5 Participants |
| MI-Only (Responder) | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | Yes | 3 Participants |
| MI-Only (Responder) | Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS) | No | 4 Participants |
Secondary
Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider
The proportion of participants reporting that they attended a medical appointment to be evaluated for PrEP.
Time frame: 6 Months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CM-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | Yes | 3 Participants |
| CM-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | No | 2 Participants |
| MI-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | Yes | 9 Participants |
| MI-Only (Non-Responder or Lost to Follow Up During Stage 1) | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | No | 4 Participants |
| CM+MI | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | Yes | 8 Participants |
| CM+MI | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | No | 1 Participants |
| MI+CM | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | Yes | 4 Participants |
| MI+CM | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | No | 3 Participants |
| CM-Only (Responder) | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | Yes | 11 Participants |
| CM-Only (Responder) | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | No | 0 Participants |
| MI-Only (Responder) | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | Yes | 7 Participants |
| MI-Only (Responder) | Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider | No | 0 Participants |