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

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Cathy Reback, Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01140880
First received: June 8, 2010
Last updated: June 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
HIV Seroconversion
Stimulant Abuse
Drug: Truvada
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Optimizing Access to Non-occupational Post Exposure Prophylaxis for HIV Using Contingency Management in Stimulant-Using Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by Friends Research Institute, Inc.:

Primary Outcome Measures:
  • Time From Exposure to Truvada Initiation [ Time Frame: 6-month follow-up ] [ Designated as safety issue: Yes ]
    Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.

  • Medication Adherence [ Time Frame: Daily throughout medication course ] [ Designated as safety issue: Yes ]
    Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.

  • Course Completion [ Time Frame: 28-days post initiation ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Thrice-weekly for 8 weeks ] [ Designated as safety issue: Yes ]
    Abstinence will be measured using thrice weekly urine drug screens and self-report


Enrollment: 170
Study Start Date: May 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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).

Drug: 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).
Sham Comparator: 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.

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).

Drug: 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140880

Locations
United States, California
Friends Community Center, A Division of Friends Research Institute, Inc.
Los Angeles, California, United States, 90028
Sponsors and Collaborators
Friends Research Institute, Inc.
University of California, Los Angeles
Investigators
Principal Investigator: Cathy J. Reback, Ph.D. Friends Research Institute, Inc.
Principal Investigator: Raphael J. Landovitz, M.D., M.Sc. UCLA Center for Clinical AIDS Research and Education
Principal Investigator: Steven Shoptaw, Ph.D. UCLA Department of Family Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Cathy Reback, Principal Investigator, Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01140880     History of Changes
Other Study ID Numbers: MC08-LA-710-FRI
Study First Received: June 8, 2010
Results First Received: May 27, 2014
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Friends Research Institute, Inc.:
Methamphetamine
Amphetamine
Cocaine
HIV
Post-exposure prophylaxis
HIV seronegativity

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014