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

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:

MedlinePlus related topics: HIV/AIDS Methamphetamine

Drug Information available for: Emtricitabine Tenofovir Tenofovir Disoproxil Fumarate Truvada

U.S. FDA Resources

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). Other Name: Tenofovir/emtricitabine
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). Other Name: Tenofovir/emtricitabine

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).

Other Name: Tenofovir/emtricitabine

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).

Other Name: Tenofovir/emtricitabine

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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:

study website This link exits the ClinicalTrials.gov site


Responsible Party:	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:	March 18, 2015
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 Tenofovir Emtricitabine	Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Central Nervous System Stimulants Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016