Amphetamine-Related DisordersPhase 2NCT00856323
Contingency Management for Methamphetamine Abstinence and HIV Post-Exposure Prophylaxis in Men Who Have Sex With Men
A Phase 2 study testing Truvada and CM in people with Amphetamine-Related Disorders and HIV, run by Friends Research Institute, Inc. at 1 site in United States.
Trial summary
This study seeks to decrease methamphetamine use and concomitant high-risk sexual behaviors among methamphetamine-using men who have sex with men (MSM) by combining a biomedical intervention with a behavioral intervention. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Amphetamine-Related Disorders, HIV, HIV Infections
- What is being tested?
- Truvada and CM
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual must identify as a male who has sex with other men (MSM);
- At least 18 years of age;
- HIV negative serostatus on baseline rapid oral HIV antibody test;
- Self-reported methamphetamine use within the previous 72 hours and test positive for methamphetamine metabolites at baseline;
- Self-reported unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months;
- Self-reports no previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine);
- Willing to comply with study requirements (i.e., monitored urine testing three times per week, meet with physician within first week of enrollment, begin medication immediately following an unexpected high-risk sexual exposure, and contact the clinic and meet with physician within 92 hours of unexpected high-risk sexual exposure).
Who cannot join
- 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 the baseline rapid oral HIV antibody test;
- Self-reports any previous hypersensitivity to any of the components of Truvada;
- Has not used methamphetamine in the previous 72 hours and does not test positive for methamphetamine metabolites;
- Has not had unprotected anal intercourse with an HIV-positive or status unknown partner within the previous 3 months;
- Unwilling to comply with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Friends Community Center
Los Angeles, California, 90028
About this study
Official title: Biobehavioral Interventions for HIV-negative Methamphetamine-using MSM
This study seeks to decrease methamphetamine use and concomitant high-risk sexual behaviors among methamphetamine-using men who have sex with men (MSM) by combining a biomedical intervention with a behavioral intervention. The behavioral intervention will consist of an 8-week course of contingency management (CM) through which participants will be reinforced for testing negative for methamphetamine metabolites during periodic urine analyses. The biomedical intervention involves a 28-day course of an antiretroviral drug (Truvada) to be administered after an unanticipated HIV risk exposure (i.e., engaging in either receptive or insertive anal sex without a condom with someone who is HIV-positive or of unknown status). In combining these two interventions, this study seeks to evaluate the combined intervention's effects on sexual risk behaviors and methamphetamine use.
Read the detailed description
At the baseline, all eligible participants underwent informed consent; completed baseline assessments; received rapid HIV testing; provided specimens for syphilis, gonorrhea and chlamydia testing; and received a medical examination. Those who reported a high-risk sexual or drug exposure episode with an HIV-positive or serostatus-unknown source within the preceding 72 hours immediately initiated postexposure prophylaxis. All other participants received a 4-day ''starter pack'' of Truvada to be initiated only in the case of a future high-risk exposure to HIV. All participants began the voucher-based CM intervention upon study entry. For the initial 8 weeks of study conduct, participants presented to the study site three times weekly for a urine drug screen for methamphetamine metabolites. Participants who provided urine samples that were negative for methamphetamine metabolites earned vouchers, which escalated in value for successive negative urine samples. A participant with a missing sample or a sample positive for methamphetamine metabolites did not earn vouchers. Accrued vouchers were never forfeited and could be redeemed at any time during the study for gift certificates or goods or services that promote healthy, pro-social behaviors; vouchers could not be redeemed for cash.
- Conditions
- Amphetamine-Related Disorders, HIV, HIV Infections
- Being tested
- Truvada, CM
- Keywords
- Methamphetamine, HIV, Post-exposure prophylaxis, HIV seronegativity
- Medical subject headings
- Amphetamine-Related Disorders, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruvadaDrug
Also called Emtricitabine and tenofovir disoproxil fumarate
At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
CMBehavioural
Also called 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 methamphetamine metabolites.
| Study group | Role | What they receive |
|---|---|---|
| PEP/CM | Experimental | Participants are provided contingency management vouchers for methamphetamine abstinence, and can initiate postexposure prophylaxis (Truvada; 1 pill daily for 28 days) after non-occupational exposure to HIV. Receives: Drug: Truvada; Behavioral: CM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Methamphetamine Use in Previous 30 Days.
Mean number of days (of the past 30) of methamphetamine use.
Measured: 3-months after baseline
Secondary outcomes (3)
Description of Incident STI Infections.
Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.
Measured: Baseline and 3-months
HIV-related Sexual Risk Behaviors in Previous 30 Days.
Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.
Measured: 3-months after baseline
Post-Exposure Prophylaxis Medication Adherence
Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed).
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amphetamine-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Cathy J Reback, Ph.D., Principal investigator, Friends Research Institute, Inc.Raphael J Landovitz, M.D., Principal investigator, UCLA Center for Clinical AIDS Research and EducationSteve Shoptaw, Ph.D., Principal investigator, UCLA Department of Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856323
- Sponsor's protocol ID
- 702632
- Status last verified
- Aug 2016
- First submitted
- 3 Mar 2009
- Last updated
- 20 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Landovitz RJ, Fletcher JB, Inzhakova G, Lake JE, Shoptaw S, Reback CJ. A novel combination HIV prevention strategy: post-exposure prophylaxis with contingency management for substance abuse treatment among methamphetamine-using men who have sex with men. AIDS Patient Care STDS. 2012 Jun;26(6):320-8. doi: 10.1089/apc.2011.0432.
PubMed 22680280Fletcher JB, Rusow JA, Le H, Landovitz RJ, Reback CJ. High-risk Sexual Behavior is Associated with Post-Exposure Prophylaxis Non-adherence among Men who have Sex with Men Enrolled in a Combination Prevention Intervention. J Sex Transm Dis. 2013;2013:210403. doi: 10.1155/2013/210403.
PubMed 24527254
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Interventions for HIV-negative Methamphetamine-using MSM
- ClinicalTrials.gov ID
- NCT00856323
- Acronym / sponsor ID
- 702632
- Conditions
- Amphetamine-Related Disorders, HIV, HIV Infections
- Keywords
- Methamphetamine, HIV, Post-exposure prophylaxis, HIV seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Mar 2009 (estimated)
- Results
- Posted 27 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to decrease methamphetamine use and concomitant high-risk sexual behaviors among methamphetamine-using men who have sex with men (MSM) by combining a biomedical intervention with a behavioral intervention. The behavioral intervention will consist of an 8-week course of contingency management (CM) through which participants will be reinforced for testing negative for methamphetamine metabolites during periodic urine analyses. The biomedical intervention involves a 28-day course of an antiretroviral drug (Truvada) to be administered after an unanticipated HIV risk exposure (i.e., engaging in either receptive or insertive anal sex without a condom with someone who is HIV-positive or of unknown status). In combining these two interventions, this study seeks to evaluate the combined intervention's effects on sexual risk behaviors and methamphetamine use.
Detailed description
At the baseline, all eligible participants underwent informed consent; completed baseline assessments; received rapid HIV testing; provided specimens for syphilis, gonorrhea and chlamydia testing; and received a medical examination. Those who reported a high-risk sexual or drug exposure episode with an HIV-positive or serostatus-unknown source within the preceding 72 hours immediately initiated postexposure prophylaxis. All other participants received a 4-day ''starter pack'' of Truvada to be initiated only in the case of a future high-risk exposure to HIV. All participants began the voucher-based CM intervention upon study entry. For the initial 8 weeks of study conduct, participants presented to the study site three times weekly for a urine drug screen for methamphetamine metabolites. Participants who provided urine samples that were negative for methamphetamine metabolites earned vouchers, which escalated in value for successive negative urine samples. A participant with a missing sample or a sample positive for methamphetamine metabolites did not earn vouchers. Accrued vouchers were never forfeited and could be redeemed at any time during the study for gift certificates or goods or services that promote healthy, pro-social behaviors; vouchers could not be redeemed for cash.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEP/CM | Experimental | Drug: Truvada, Behavioral: CMParticipants are provided contingency management vouchers for methamphetamine abstinence, and can initiate postexposure prophylaxis (Truvada; 1 pill daily for 28 days) after non-occupational exposure to HIV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individual must identify as a male who has sex with other men (MSM);
- At least 18 years of age;
- HIV negative serostatus on baseline rapid oral HIV antibody test;
- Self-reported methamphetamine use within the previous 72 hours and test positive for methamphetamine metabolites at baseline;
- Self-reported unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months;
Key exclusion criteria (7 listed)
- 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 the baseline rapid oral HIV antibody test;
- Self-reports any previous hypersensitivity to any of the components of Truvada;
- Has not used methamphetamine in the previous 72 hours and does not test positive for methamphetamine metabolites;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruvadaAlso: Emtricitabine and tenofovir disoproxil fumarateAt qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada). | Drug | PEP/CM |
| CMAlso: Contingency ManagementParticipants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites. | Behavioural | PEP/CM |
Primary outcome
Self-reported Methamphetamine Use in Previous 30 Days.
Time frame: 3-months after baseline
Mean number of days (of the past 30) of methamphetamine use.
3 secondary outcomes
Description of Incident STI Infections.
Time frame: Baseline and 3-months
HIV-related Sexual Risk Behaviors in Previous 30 Days.
Time frame: 3-months after baseline
Post-Exposure Prophylaxis Medication Adherence
Time frame: 28-days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22680280Landovitz RJ, Fletcher JB, Inzhakova G, Lake JE, Shoptaw S, Reback CJ. A novel combination HIV prevention strategy: post-exposure prophylaxis with contingency management for substance abuse treatment among methamphetamine-using men who have sex with men. AIDS Patient Care STDS. 2012 Jun;26(6):320-8. doi: 10.1089/apc.2011.0432.
- Derived from this study: PubMed 24527254Fletcher JB, Rusow JA, Le H, Landovitz RJ, Reback CJ. High-risk Sexual Behavior is Associated with Post-Exposure Prophylaxis Non-adherence among Men who have Sex with Men Enrolled in a Combination Prevention Intervention. J Sex Transm Dis. 2013;2013:210403. doi: 10.1155/2013/210403.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy J Reback, Ph.D. principal investigator
Friends Research Institute, Inc.
Raphael J Landovitz, M.D. principal investigator
UCLA Center for Clinical AIDS Research and Education
Steve Shoptaw, Ph.D. principal investigator
UCLA Department of Family Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Truvada and CM in people with Amphetamine-Related Disorders and HIV, run by Friends Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Methamphetamine Use in Previous 30 Days. (time frame: 3-months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00856323, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.