HIVPhase 1/2NCT01174654
Development of a Methamphetamine Early Intervention
A Phase 1/2 study testing Contingency management in people with HIV and Sexual Behavior, run by University of Washington at 1 site in United States.
Trial summary
Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and some authorities have advocated methamphetamine treatment as an HIV prevention strategy. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexual Behavior, Methamphetamine
- What is being tested?
- Contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Apr 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Anal sex with another man in the month prior to enrollment
- Use of methamphetamine on at least 2 days in the month prior to enrollment
Who cannot join
- Plans to move from the study catchment area within 6 months of enrollment
- A mutually monogamous relationships with a man of the same HIV status lasting 2 or more years
Trial locations and contacts
1 site in 1 country.
About this study
Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and some authorities have advocated methamphetamine treatment as an HIV prevention strategy. However, methamphetamine interventions have not been evaluated in controlled trials, nor have they been implemented and assessed outside of substance abuse treatment programs. This application proposes preliminary investigations to adapt a methamphetamine treatment intervention previously associated with decreased sexual-risk taking among MSM for use as an early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be enrolled in a randomized controlled trial of contingency management (CM) versus no intervention. CM participants will have their urine tested for methamphetamine 3 times weekly for 12 weeks, and will receive vouchers of escalating value when their urines test negative; vouchers will be withheld when participants' urines test positive for methamphetamine or participants miss urine testing visits. All participants will undergo urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior and substance use at baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and 6 month follow-up. The study will determine how often MSM will initiate and complete the early intervention, and will longitudinally measure unsafe sexual behaviors among intervention and control participants. Study results will determine the feasibility of instituting and studying CM as an early intervention; define whether the intervention is sufficiently promising to justify a larger, definitive randomized controlled trial; and will provide estimates for defining the number of participants such a trial would require.
- Conditions
- HIV, Sexual Behavior, Methamphetamine, Behavioral Research
- Being tested
- Contingency management
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency managementBehavioural
Also called Voucher-based reinforcement
A 12-week contingency management intervention
| Study group | Role | What they receive |
|---|---|---|
| Referral to community resources | No intervention | Not described |
| Contingency Management | Experimental | Not described Receives: Behavioral: Contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-concordant unprotected anal intercourse
Measured: Baseline, 6, 12, 18, 24 weeks
Secondary outcomes (3)
Number of non-concordant unprotected anal intercourse partners
Measured: Baseline, 6, 12, 18, 24 weeks
Stimulant (methamphetamine and crack/cocaine) urinalyses
Measured: Baseline, 6, 12, 18, 24 weeks
Self-reported methamphetamine use
Measured: Baseline, 6, 12, 18, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startDec 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Matthew Golden, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174654
- Sponsor's protocol ID
- R21DA019420-01A1
- Other IDs
- R21DA019420-01A1
- Status last verified
- Dec 2012
- First submitted
- 2 Aug 2010
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Menza TW, Jameson DR, Hughes JP, Colfax GN, Shoptaw S, Golden MR. Contingency management to reduce methamphetamine use and sexual risk among men who have sex with men: a randomized controlled trial. BMC Public Health. 2010 Dec 20;10:774. doi: 10.1186/1471-2458-10-774.
PubMed 21172026
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Methamphetamine Early Intervention
- ClinicalTrials.gov ID
- NCT01174654
- Acronym / sponsor ID
- R21DA019420-01A1
- Conditions
- HIV, Sexual Behavior, Methamphetamine, Behavioral Research
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 3 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and some authorities have advocated methamphetamine treatment as an HIV prevention strategy. However, methamphetamine interventions have not been evaluated in controlled trials, nor have they been implemented and assessed outside of substance abuse treatment programs. This application proposes preliminary investigations to adapt a methamphetamine treatment intervention previously associated with decreased sexual-risk taking among MSM for use as an early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be enrolled in a randomized controlled trial of contingency management (CM) versus no intervention. CM participants will have their urine tested for methamphetamine 3 times weekly for 12 weeks, and will receive vouchers of escalating value when their urines test negative; vouchers will be withheld when participants' urines test positive for methamphetamine or participants miss urine testing visits. All participants will undergo urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior and substance use at baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and 6 month follow-up. The study will determine how often MSM will initiate and complete the early intervention, and will longitudinally measure unsafe sexual behaviors among intervention and control participants. Study results will determine the feasibility of instituting and studying CM as an early intervention; define whether the intervention is sufficiently promising to justify a larger, definitive randomized controlled trial; and will provide estimates for defining the number of participants such a trial would require.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referral to community resources | No intervention | – |
| Contingency Management | Experimental | Behavioral: Contingency management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Anal sex with another man in the month prior to enrollment
- Use of methamphetamine on at least 2 days in the month prior to enrollment
Key exclusion criteria (2 listed)
- Plans to move from the study catchment area within 6 months of enrollment
- A mutually monogamous relationships with a man of the same HIV status lasting 2 or more years
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 |
|---|---|---|
| Contingency managementAlso: Voucher-based reinforcementA 12-week contingency management intervention | Behavioural | Contingency Management |
Primary outcome
Non-concordant unprotected anal intercourse
Time frame: Baseline, 6, 12, 18, 24 weeks
3 secondary outcomes
Number of non-concordant unprotected anal intercourse partners
Time frame: Baseline, 6, 12, 18, 24 weeks
Stimulant (methamphetamine and crack/cocaine) urinalyses
Time frame: Baseline, 6, 12, 18, 24 weeks
Self-reported methamphetamine use
Time frame: Baseline, 6, 12, 18, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
- Derived from this study: PubMed 21172026Menza TW, Jameson DR, Hughes JP, Colfax GN, Shoptaw S, Golden MR. Contingency management to reduce methamphetamine use and sexual risk among men who have sex with men: a randomized controlled trial. BMC Public Health. 2010 Dec 20;10:774. doi: 10.1186/1471-2458-10-774.
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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.
Matthew Golden principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Contingency management in people with HIV and Sexual Behavior, run by University of Washington 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 2 inclusion and 2 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 13 Dec 2012. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Non-concordant unprotected anal intercourse (time frame: Baseline, 6, 12, 18, 24 weeks). 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 NCT01174654, which also lists 1 linked publication.
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 13 Dec 2012.