HIV Seroconversion, Stimulant Abuse
Conditions
Keywords
Methamphetamine, Amphetamine, Cocaine, HIV, Post-exposure prophylaxis, HIV seronegativity
Brief summary
This study seeks to evaluate the efficacy of a contingency management (CM) intervention compared to a yoked control condition for eliminating illicit stimulant use and for decreasing time to initiating post exposure prophylaxis (PEP), for improving adherence to PEP, and for completing PEP following a potential HIV-exposure event. Men who have sex with men who use cocaine amphetamine or methamphetamine frequently also have high risk sexual behaviors during or after their drug use. The objective of this study evaluates whether the use of CM that targets stimulant use significantly aids men who have sex with men who use stimulants and also engage in high-risk sexual transmission behaviors to be able to initiate, adhere to and complete PEP, thereby optimizing the utility of a biomedical HIV prevention intervention for reducing HIV incidence in this very high-risk group of MSM.
Detailed description
This was a prospective, randomized study. 170 participants who met inclusion and exclusion criteria were randomized to CM or NCYC (non-contingent yoked-control condition) arms. They were provided with a 4-day starter-pack of PEP medication (tenofovir + emtricitabine, Truvada) to be started only in the event of a high-risk sexual exposure. The two interventions were implemented simultaneously: The CM or NCYC intervention, remunerating (via vouchers) the participant based on his own (CM) or a yoked-participant's (NCYC) stimulant-metabolite-free urine samples for 8 weeks; and, Post-exposure prophylaxis, providing risk reduction counseling, adherence counseling and PEP medication for 28 days in the event of a high-risk sexual exposure to HIV. All participants were followed for 24 weeks, or 24-weeks post-HIV-exposure, whichever was longer.
Interventions
DRUGTruvada
Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
Sponsors
University of California, Los Angeles
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male who has sex with other men (MSM) by self-report * At least 18 years of age * HIV-negative serostatus on baseline rapid oral HIV antibody test, and no signs or symptoms consistent with primary HIV infection (PHI) * Self-reported stimulant use within the previous 30 days * Self-report of unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months * Self-report of no previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine) * In the opinion of the study medical provider, no contraindication to PEP medication treatment (laboratory testing, medical/drug interaction, or other) * Has not used PEP in the previous 6 months * A current resident of Los Angeles County * Does not have a plan to move away from Los Angeles County in the next 6 months * Willing and able to provide informed consent * Willing and able to comply with study requirements
Exclusion criteria
* Does not identify as a male who has sex with other men * Under 18 years of age * HIV positive by self-report or as indicated by the results on baseline rapid oral HIV antibody testing * Has not used a stimulant in the previous 30 days by self-report * Has not had unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months * Creatinine clearance \<30 ml/min and not on dialysis * Self-reports any previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine); * In the opinion of the study medical provider, there exists a contraindication to administering Truvada-based post-exposure prophylaxis (laboratory testing, medical/drug interaction, or other) * Has used PEP in the previous six months * Not a current resident of Los Angeles County * Unwilling or unable to provide informed consent * Unwilling or unable to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Exposure to Truvada Initiation | 6-month follow-up | Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen. |
| Medication Adherence | Daily throughout medication course | Adherence to Truvada medication (if initiated) as assessed by self-report and pill count. |
| Course Completion | 28-days post initiation | PEP course completion is a dichotomous variable (0 = Not completed; 1 = Completed) that indicates whether the participant maintained sufficient adherence to the Truvada regimen to receive all 28 doses of the medication. Note: Missing 3 Truvada doses in a row terminated the PEP-intervention and prevented Course Completion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine) | Thrice-weekly for 8 weeks | Abstinence will be measured using thrice weekly urine drug screens and self-report |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Contingency Management Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada). | 70 |
| Yoked Contingency Management Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.
Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada). | 70 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 8 | 10 |
| Overall Study | Protocol Violation | 0 | 30 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Total | Yoked Contingency Management | Contingency Management |
|---|---|---|---|
| Age, Continuous | 36.8 years STANDARD_DEVIATION 11.1 | 37.9 years STANDARD_DEVIATION 11.8 | 35.8 years STANDARD_DEVIATION 10.3 |
| Race/Ethnicity, Customized African American/black | 52 participants | 25 participants | 27 participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 3 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Caucasian/white | 52 participants | 25 participants | 27 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 25 participants | 14 participants | 11 participants |
| Race/Ethnicity, Customized Multiracial/Other | 4 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Native American | 4 participants | 3 participants | 1 participants |
| Region of Enrollment United States | 140 participants | 70 participants | 70 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 140 Participants | 70 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 70 | 0 / 70 |
| serious Total, serious adverse events | 1 / 70 | 1 / 70 |
Outcome results
Primary
Course Completion
PEP course completion is a dichotomous variable (0 = Not completed; 1 = Completed) that indicates whether the participant maintained sufficient adherence to the Truvada regimen to receive all 28 doses of the medication. Note: Missing 3 Truvada doses in a row terminated the PEP-intervention and prevented Course Completion.
Time frame: 28-days post initiation
Population: 40 participants initiated PEP during the study, of which 30 had evaluable course completion data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management | Course Completion | 12 participants |
| Yoked Contingency Management | Course Completion | 4 participants |
Primary
Medication Adherence
Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.
Time frame: Daily throughout medication course
Population: 40 participants initiated Truvada, of which 30 had evaluable medication adherence and course completion data (the 10 others were involved in the protocol violation).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contingency Management | Medication Adherence | 0.75 proportion |
| Yoked Contingency Management | Medication Adherence | 0.45 proportion |
Primary
Time From Exposure to Truvada Initiation
Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.
Time frame: 6-month follow-up
Population: 40 participants with evaluable data initiated Truvada during the course of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management | Time From Exposure to Truvada Initiation | 32.8 hours | Standard Deviation 15.1 |
| Yoked Contingency Management | Time From Exposure to Truvada Initiation | 33.0 hours | Standard Deviation 16.1 |
Secondary
Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)
Abstinence will be measured using thrice weekly urine drug screens and self-report
Time frame: Thrice-weekly for 8 weeks
Population: 170 participants enrolled in the study, of which 30 were involved in a protocol violation that rendered their data un-analyzable. The final analytical sample is N = 140.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management | Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine) | 8.9 Stimulant-free urinalyses | Standard Deviation 9.2 |
| Yoked Contingency Management | Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine) | 6.0 Stimulant-free urinalyses | Standard Deviation 6.1 |