Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men

HIV Infections Clinical Trial

Official title:

Biobehavioral Interventions for HIV-negative Methamphetamine-using MSM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00856323
• Other study ID #: 702632
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2009
• Last updated: March 18, 2015
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2015
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Amphetamine-Related Disorders
• HIV
• HIV Infections

Intervention

Drug:
• 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).

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Friends Community Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (1)

Landovitz RJ, Fletcher JB, Inzhakova G, Lake JE, Shoptaw S, Reback CJ. A novel combination HIV prevention strategy: post-exposure prophylaxis with contingency management for substance abuse treatment among methamphetamine-using men who have sex with men. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported Methamphetamine Use in Previous 30 Days.	Mean number of days (of the past 30) of methamphetamine use.	3-months after baseline	Yes
Secondary	Description of Incident STI Infections.	Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.	Baseline and 3-months	Yes
Secondary	HIV-related Sexual Risk Behaviors in Previous 30 Days.	Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.	3-months after baseline	Yes
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).	28-days	Yes