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

• Sponsor: Friends Research Institute, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01140880
• Collaborator: University of California, Los Angeles (Other)
• Enrollment: 170
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Seroconversion; Stimulant Abuse	Drug: Truvada	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Tenofovir/emtricitabine

Outcome Measures

Primary Outcome Measures

1. Time From Exposure to Truvada Initiation [6-month follow-up]

   Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.

2. Medication Adherence [Daily throughout medication course]

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

3. Course Completion [28-days post initiation]

   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

1. Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine) [Thrice-weekly for 8 weeks]

   Abstinence will be measured using thrice weekly urine drug screens and self-report

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Friends Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT01140880
• Other Study ID Numbers: MC08-LA-710-FRI
• First Posted: Jun 10, 2010
• Last Update Posted: Apr 7, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Friends Research Institute, Inc.: Methamphetamine; Amphetamine; Cocaine; HIV; Post-exposure prophylaxis; HIV seronegativity
• Additional relevant MeSH terms: HIV Seropositivity; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Study Results

Participant Flow

Arm/Group Title	Contingency Management	Yoked Contingency Management
Arm/Group Description	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. 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).	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. 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).
Period Title: Overall Study
STARTED	70	100
COMPLETED	56	56
NOT COMPLETED	14	44

Baseline Characteristics

Arm/Group Title	Contingency Management	Yoked Contingency Management	Total
Arm/Group Description	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. 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).	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. 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).	Total of all reporting groups
Overall Participants	70	70	140
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.8 (10.3)	37.9 (11.8)	36.8 (11.1)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	70 100%	70 100%	140 100%
Race/Ethnicity, Customized (participants) [Number]
Caucasian/white	27 38.6%	25 35.7%	52 37.1%
African American/black	27 38.6%	25 35.7%	52 37.1%
Native American	1 1.4%	3 4.3%	4 2.9%
Asian/Pacific Islander	2 2.9%	1 1.4%	3 2.1%
Hispanic/Latino	11 15.7%	14 20%	25 17.9%
Multiracial/Other	2 2.9%	2 2.9%	4 2.9%
Region of Enrollment (participants) [Number]
United States	70 100%	70 100%	140 100%

Outcome Measures

1. Primary Outcome

Title	Time From Exposure to Truvada Initiation
Description	Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.
Time Frame	6-month follow-up

Outcome Measure Data

Analysis Population Description

40 participants with evaluable data initiated Truvada during the course of the study.

Arm/Group Title	Contingency Management	Yoked Contingency Management
Arm/Group Description	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. 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).	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. 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).
Measure Participants	26	14
Mean (Standard Deviation) [hours]	32.8 (15.1)	33.0 (16.1)

2. Secondary Outcome

Title	Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)
Description	Abstinence will be measured using thrice weekly urine drug screens and self-report
Time Frame	Thrice-weekly for 8 weeks

Outcome Measure Data

Analysis Population Description

170 participants enrolled in the study, of which 30 were involved in a protocol violation that rendered their data un-analyzable. The final analytical sample is N = 140.

Arm/Group Title	Contingency Management	Yoked Contingency Management
Arm/Group Description	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. 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).	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. 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).
Measure Participants	70	70
Mean (Standard Deviation) [Stimulant-free urinalyses]	8.9 (9.2)	6.0 (6.1)

3. Primary Outcome

Title	Medication Adherence
Description	Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.
Time Frame	Daily throughout medication course

Outcome Measure Data

Analysis Population Description

40 participants initiated Truvada, of which 30 had evaluable medication adherence and course completion data (the 10 others were involved in the protocol violation).

Arm/Group Title	Contingency Management	Yoked Contingency Management
Arm/Group Description	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. 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).	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. 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).
Measure Participants	17	13
Number [proportion]	0.75 (NA)	0.45 (NA)

4. Primary Outcome

Title	Course Completion
Description	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.
Time Frame	28-days post initiation

Outcome Measure Data

Analysis Population Description

40 participants initiated PEP during the study, of which 30 had evaluable course completion data.

Arm/Group Title	Contingency Management	Yoked Contingency Management
Arm/Group Description	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. 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).	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. 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).
Measure Participants	17	13
Number [participants]	12 17.1%	4 5.7%

Adverse Events

Time Frame	From enrollment to 6-month follow-up.
Arm/Group Title	Contingency Management		Yoked Contingency Management
Arm/Group Description	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. 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).		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. 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).
All Cause Mortality
	Contingency Management		Yoked Contingency Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Contingency Management		Yoked Contingency Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/70 (1.4%)		1/70 (1.4%)
General disorders
Death	0/70 (0%)	0	1/70 (1.4%)	1
Psychiatric disorders
Suicidal Ideation/Exacerbated Depression	1/70 (1.4%)	1	0/70 (0%)	0
Other (Not Including Serious) Adverse Events
	Contingency Management		Yoked Contingency Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/70 (11.4%)		0/70 (0%)
Eye disorders
Eye Swelling	1/70 (1.4%)	1	0/70 (0%)	0
Gastrointestinal disorders
Heartburn	1/70 (1.4%)	1	0/70 (0%)	0
Diarrhea	2/70 (2.9%)	2	0/70 (0%)	0
Rectal Bleeding	1/70 (1.4%)	1	0/70 (0%)	0
Abdominal Pain	1/70 (1.4%)	1	0/70 (0%)	0
General disorders
Tooth Pain	1/70 (1.4%)	1	0/70 (0%)	0
Insomnia	1/70 (1.4%)	1	0/70 (0%)	0
Fatigue	1/70 (1.4%)	1	0/70 (0%)	0
Hot Flashes	1/70 (1.4%)	1	0/70 (0%)	0
Lightheadedness	1/70 (1.4%)	1	0/70 (0%)	0
Skin and subcutaneous tissue disorders
Ulcer on Hand	1/70 (1.4%)	1	0/70 (0%)	0
Throat Swelling	1/70 (1.4%)	1	0/70 (0%)	0
Profuse Sweating	1/70 (1.4%)	1	0/70 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.