Biobehavioral Interventions for HIV-negative, Stimulant Using Men Who Have Sex With Men
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ClinicalTrials.gov Identifier: NCT01140880 |
Recruitment Status
:
Completed
First Posted
: June 10, 2010
Results First Posted
: July 2, 2014
Last Update Posted
: April 7, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Seroconversion Stimulant Abuse | Drug: Truvada | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
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 2010 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |

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 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
|
- Time From Exposure to Truvada Initiation [ Time Frame: 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.
- Medication Adherence [ Time Frame: Daily throughout medication course ]Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.
- Course Completion [ Time Frame: 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.
- Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine) [ Time Frame: Thrice-weekly for 8 weeks ]Abstinence will be measured using thrice weekly urine drug screens and self-report

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140880
United States, California | |
Friends Community Center, A Division of Friends Research Institute, Inc. | |
Los Angeles, California, United States, 90028 |
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 |
Additional Information:
Responsible Party: | Friends Research Institute, Inc. |
ClinicalTrials.gov Identifier: | NCT01140880 History of Changes |
Other Study ID Numbers: |
MC08-LA-710-FRI |
First Posted: | June 10, 2010 Key Record Dates |
Results First Posted: | July 2, 2014 |
Last Update Posted: | April 7, 2015 |
Last Verified: | March 2015 |
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 |