Amphetamine-Related Disorders, HIV, HIV Infections
Conditions
Keywords
Methamphetamine, HIV, Post-exposure prophylaxis, HIV seronegativity
Brief summary
This study seeks to decrease methamphetamine use and concomitant high-risk sexual behaviors among methamphetamine-using men who have sex with men (MSM) by combining a biomedical intervention with a behavioral intervention. The behavioral intervention will consist of an 8-week course of contingency management (CM) through which participants will be reinforced for testing negative for methamphetamine metabolites during periodic urine analyses. The biomedical intervention involves a 28-day course of an antiretroviral drug (Truvada) to be administered after an unanticipated HIV risk exposure (i.e., engaging in either receptive or insertive anal sex without a condom with someone who is HIV-positive or of unknown status). In combining these two interventions, this study seeks to evaluate the combined intervention's effects on sexual risk behaviors and methamphetamine use.
Detailed description
At the baseline, all eligible participants underwent informed consent; completed baseline assessments; received rapid HIV testing; provided specimens for syphilis, gonorrhea and chlamydia testing; and received a medical examination. Those who reported a high-risk sexual or drug exposure episode with an HIV-positive or serostatus-unknown source within the preceding 72 hours immediately initiated postexposure prophylaxis. All other participants received a 4-day ''starter pack'' of Truvada to be initiated only in the case of a future high-risk exposure to HIV. All participants began the voucher-based CM intervention upon study entry. For the initial 8 weeks of study conduct, participants presented to the study site three times weekly for a urine drug screen for methamphetamine metabolites. Participants who provided urine samples that were negative for methamphetamine metabolites earned vouchers, which escalated in value for successive negative urine samples. A participant with a missing sample or a sample positive for methamphetamine metabolites did not earn vouchers. Accrued vouchers were never forfeited and could be redeemed at any time during the study for gift certificates or goods or services that promote healthy, pro-social behaviors; vouchers could not be redeemed for cash.
Interventions
DRUGTruvada
At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
BEHAVIORALCM
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 methamphetamine metabolites.
Sponsors
University of California, Los Angeles
Friends Research Institute, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individual must identify as a male who has sex with other men (MSM); * At least 18 years of age; * HIV negative serostatus on baseline rapid oral HIV antibody test; * Self-reported methamphetamine use within the previous 72 hours and test positive for methamphetamine metabolites at baseline; * Self-reported unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months; * Self-reports no previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine); * Willing to comply with study requirements (i.e., monitored urine testing three times per week, meet with physician within first week of enrollment, begin medication immediately following an unexpected high-risk sexual exposure, and contact the clinic and meet with physician within 92 hours of unexpected high-risk sexual exposure).
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 the baseline rapid oral HIV antibody test; * Self-reports any previous hypersensitivity to any of the components of Truvada; * Has not used methamphetamine in the previous 72 hours and does not test positive for methamphetamine metabolites; * Has not had unprotected anal intercourse with an HIV-positive or status unknown partner within the previous 3 months; * Unwilling to comply with study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Methamphetamine Use in Previous 30 Days. | 3-months after baseline | Mean number of days (of the past 30) of methamphetamine use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of Incident STI Infections. | Baseline and 3-months | Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia. |
| HIV-related Sexual Risk Behaviors in Previous 30 Days. | 3-months after baseline | Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days. |
| Post-Exposure Prophylaxis Medication Adherence | 28-days | Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed). |
Countries
United States
Participant flow
Recruitment details
Between March 2009 and August 2010, 358 individuals inquired about the study on the basis of recruitment efforts, 64 presented for screening, and 53 participants enrolled in the study.
Pre-assignment details
Reasons for Screen Failure (N = 7): HIV-positive at baseline screening; negative urine screen for methamphetamine§; did not complete baseline assessments; provided incorrect information at phone screening.
Participants by arm
| Arm | Count |
|---|---|
| PEP/CM 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).
CM : 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 methamphetamine metabolites. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | PEP/CM |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants |
| Age, Continuous | 36.1 years STANDARD_DEVIATION 7.9 |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 53 |
| serious Total, serious adverse events | 2 / 53 |
Outcome results
Primary
Self-reported Methamphetamine Use in Previous 30 Days.
Mean number of days (of the past 30) of methamphetamine use.
Time frame: 3-months after baseline
Population: 53 enrolled and 2 were withdrawn.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEP/CM | Self-reported Methamphetamine Use in Previous 30 Days. | 1.6 days | Standard Deviation 2.4 |
Secondary
Description of Incident STI Infections.
Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.
Time frame: Baseline and 3-months
Population: 53 enrolled and 2 were withdrawn.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PEP/CM | Description of Incident STI Infections. | .074 Proportion of Participants |
Secondary
HIV-related Sexual Risk Behaviors in Previous 30 Days.
Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.
Time frame: 3-months after baseline
Population: 53 enrolled and 2 were withdrawn.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEP/CM | HIV-related Sexual Risk Behaviors in Previous 30 Days. | .44 episodes | Standard Deviation 1.4 |
Secondary
Post-Exposure Prophylaxis Medication Adherence
Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed).
Time frame: 28-days
Population: 35 participants initiated PEP
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEP/CM | Post-Exposure Prophylaxis Medication Adherence | 0.96 proportional medication adherence |