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

NCT01140880 | Completed Phase 2 Results DMC

• 1 other identifier: MC08-LA-710-FRI
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Seroconversion; Stimulant Abuse

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  6-month follow-up

• Medication Adherence

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

  Daily throughout medication course

• 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.

  28-days post initiation

Secondary Outcomes (1)

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

  Thrice-weekly for 8 weeks

Study Arms (2)

Contingency Management

EXPERIMENTAL

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

Yoked Contingency Management

SHAM COMPARATOR

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

Interventions

Truvada 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).

Also known as: Tenofovir/emtricitabine

Contingency Management; Yoked Contingency Management

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

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

Los Angeles, California, 90028, United States

Location

MeSH Terms

Conditions

HIV Seropositivity

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir; Emtricitabine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Cathy J. Reback
• Organization: Friends Research Institute, Inc.

reback@friendsresearch.org

323-463-1601

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 10, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 17, 2025
• Results First Posted: July 2, 2014

Record last verified: 2025-03

Locations

US (1)