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

Primary Purpose

Amphetamine-Related Disorders, HIV, HIV Infections

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Truvada

About this trial

This is an interventional prevention trial for Amphetamine-Related Disorders focused on measuring Methamphetamine, HIV, Post-exposure prophylaxis, HIV seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Friends Community Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEP/CM

Arm Description

Participants are provided contingency management vouchers for methamphetamine abstinence, and can initiate postexposure prophylaxis (Truvada; 1 pill daily for 28 days) after non-occupational exposure to HIV.

Outcomes

Primary Outcome Measures

Self-reported Methamphetamine Use in Previous 30 Days.

Mean number of days (of the past 30) of methamphetamine use.

Secondary Outcome Measures

Description of Incident STI Infections.

Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.

HIV-related Sexual Risk Behaviors in Previous 30 Days.

Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.

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).

Full Information

NCT ID

NCT00856323

First Posted

March 3, 2009

Last Updated

August 12, 2016

Sponsor

Friends Research Institute, Inc.

Collaborators

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT00856323

Brief Title

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

Official Title

Biobehavioral Interventions for HIV-negative Methamphetamine-using MSM

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Friends Research Institute, Inc.

Collaborators

University of California, Los Angeles

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amphetamine-Related Disorders, HIV, HIV Infections

Keywords

Methamphetamine, HIV, Post-exposure prophylaxis, HIV seronegativity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PEP/CM

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Truvada

Other Intervention Name(s)

Emtricitabine and tenofovir disoproxil fumarate

Intervention Description

At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).

Intervention Type

Behavioral

Intervention Name(s)

Other Intervention Name(s)

Contingency Management

Intervention Description

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.

Primary Outcome Measure Information:

Title

Self-reported Methamphetamine Use in Previous 30 Days.

Description

Mean number of days (of the past 30) of methamphetamine use.

Time Frame

3-months after baseline

Secondary Outcome Measure Information:

Title

Description of Incident STI Infections.

Description

Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.

Time Frame

Baseline and 3-months

Title

HIV-related Sexual Risk Behaviors in Previous 30 Days.

Description

Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.

Time Frame

3-months after baseline

Title

Post-Exposure Prophylaxis Medication Adherence

Description

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cathy J Reback, Ph.D.

Organizational Affiliation

Friends Research Institute, Inc.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Raphael J Landovitz, M.D.

Organizational Affiliation

UCLA Center for Clinical AIDS Research and Education

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steve Shoptaw, Ph.D.

Organizational Affiliation

UCLA Department of Family Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Friends Community Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90028

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22680280

Citation

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. AIDS Patient Care STDS. 2012 Jun;26(6):320-8. doi: 10.1089/apc.2011.0432.

Results Reference

result

PubMed Identifier

24527254

Citation

Fletcher JB, Rusow JA, Le H, Landovitz RJ, Reback CJ. High-risk Sexual Behavior is Associated with Post-Exposure Prophylaxis Non-adherence among Men who have Sex with Men Enrolled in a Combination Prevention Intervention. J Sex Transm Dis. 2013;2013:210403. doi: 10.1155/2013/210403.

Results Reference

derived

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

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