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Biobehavioral Interventions for HIV-negative, Stimulant Using Men Who Have Sex With Men

Primary Purpose

HIV Seroconversion, Stimulant Abuse

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Truvada

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Friends Community Center, A Division of Friends Research Institute, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Contingency Management

Yoked Contingency Management

Arm 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 stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs. Participants reporting recent (i.e., < 48 hours) exposure to HIV viral inoculum will have the opportunity to initiate Truvada (1 pill daily for 28 days).

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. Participants reporting recent (i.e., < 48 hours) exposure to HIV viral inoculum will have the opportunity to initiate Truvada (1 pill daily for 28 days).

Outcomes

Primary Outcome Measures

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.

Medication Adherence

Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.

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.

Secondary Outcome Measures

Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)

Abstinence will be measured using thrice weekly urine drug screens and self-report

Full Information

NCT ID

NCT01140880

First Posted

June 8, 2010

Last Updated

March 18, 2015

Sponsor

Friends Research Institute, Inc.

Collaborators

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT01140880

Brief Title

Biobehavioral Interventions for HIV-negative, Stimulant Using Men Who Have Sex With Men

Official Title

Optimizing Access to Non-occupational Post Exposure Prophylaxis for HIV Using Contingency Management in Stimulant-Using Men Who Have Sex With Men

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (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 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.

6. Conditions and Keywords

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

HIV Seroconversion, Stimulant Abuse

Keywords

Methamphetamine, Amphetamine, Cocaine, HIV, Post-exposure prophylaxis, HIV seronegativity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Contingency Management

Arm Type

Experimental

Arm Description

Arm Title

Yoked Contingency Management

Arm Type

Sham Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Truvada

Other Intervention Name(s)

Tenofovir/emtricitabine

Intervention Description

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).

Primary Outcome Measure Information:

Title

Time From Exposure to Truvada Initiation

Description

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

Title

Medication Adherence

Description

Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.

Time Frame

Daily throughout medication course

Title

Course Completion

Description

Time Frame

28-days post initiation

Secondary Outcome Measure Information:

Title

Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)

Description

Abstinence will be measured using thrice weekly urine drug screens and self-report

Time Frame

Thrice-weekly for 8 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

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., M.Sc.

Organizational Affiliation

UCLA Center for Clinical AIDS Research and Education

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steven Shoptaw, Ph.D.

Organizational Affiliation

UCLA Department of Family Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Friends Community Center, A Division of Friends Research Institute, Inc.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90028

Country

United States

12. IPD Sharing Statement

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Biobehavioral Interventions for HIV-negative, Stimulant Using Men Who Have Sex With Men

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