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

Information source: Friends Research Institute, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Seroconversion; Stimulant Abuse

Intervention: Truvada (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Friends Research Institute, Inc.

Official(s) and/or principal investigator(s):
Cathy J. Reback, Ph.D., Principal Investigator, Affiliation: Friends Research Institute, Inc.
Raphael J. Landovitz, M.D., M.Sc., Principal Investigator, Affiliation: UCLA Center for Clinical AIDS Research and Education
Steven Shoptaw, Ph.D., Principal Investigator, Affiliation: UCLA Department of Family Medicine

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Time From Exposure to Truvada Initiation

Medication Adherence

Course Completion

Secondary outcome: Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Friends Community Center, A Division of Friends Research Institute, Inc., Los Angeles, California 90028, United States
Additional Information

study website

Starting date: May 2010
Last updated: March 18, 2015

Page last updated: August 20, 2015

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