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

Stimulant Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140880
• Other study ID #: MC08-LA-710-FRI
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2010
• Last updated: March 18, 2015
• Start date: May 2010
• Est. completion date: March 2013

Study information

• Verified date: March 2015
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Seroconversion
• HIV Seropositivity
• Stimulant Abuse

Intervention

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).

Locations

Country	Name	City	State
United States	Friends Community Center, A Division of Friends Research Institute, Inc.	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Medication Adherence	Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.	Daily throughout medication course	Yes
Primary	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	Yes
Secondary	Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)	Abstinence will be measured using thrice weekly urine drug screens and self-report	Thrice-weekly for 8 weeks	Yes

External Links

•   study website