HIVMetroMatesNCT01201083
Study of Recently HIV Infected Men and Transmission Behaviors
An observational study of HIV, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Identify drug use patterns and partnership dynamics that mediate risk behaviors over time in a cohort of recently HIV infected men and their partners; to determine predictors of transmission risk within partnerships of recently HIV infected men and their partners, using the partnership as the unit of analysis; and to… 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
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2018
- Phase
- Observational
- 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
Study population: STI/HIV testing and treatment clinic
Who may be able to join
- 18 years of age or older Male Documented HIV infection that occurred within previous 12 months Willing to complete study procedures Mentally competent to give informed consent Willingness to refer partners to study Ability to complete practice questions for the web-based system
Who cannot join
- Less than 18 years of age No report of sex with another man in the past 12 months
- Unwilling to be tested for HIV including:
- Unwilling to complete study follow-up questionnaires Not mentally competent to understand study procedures and give informed consent Unwilling to provide an email address or create one for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Gay and Lesbian Center
Los Angeles, California, 90028
About this study
Official title: Transmission Behavior in Partnerships of Newly HIV Infected Southern Californians
Identify drug use patterns and partnership dynamics that mediate risk behaviors over time in a cohort of recently HIV infected men and their partners; to determine predictors of transmission risk within partnerships of recently HIV infected men and their partners, using the partnership as the unit of analysis; and to quantify the long-term population-level impacts of voluntary behavior change by men with recent HIV infection, through the use of dynamic mathematical modeling that integrates our data on behavior change with current estimates of temporal infectiousness patterns. The investigators will also determine whether more frequent testing and/or development of tests with earlier sensitivity may have a significant impact on the epidemic. Finally, the magnitude of this effect to that obtained by decreasing drug use or risky sexual behavior prior to or following seroconversion will be compared. This will be conducted as a statistical analysis by co-investigators at the University of Washington.
Read the detailed description
People who recently became infected with HIV often have a high level of the virus and may be highly infectious. If they have sex (especially anal intercourse) without condoms soon after they have been infected with HIV, there is a great chance that they may transmit the virus to others. When they learn of their HIV infection, some but not all men change sexual behaviors so as not to infect their partner(s) with HIV. Possible reasons for such behavior change include increase or decrease in drug use and what is going on within their sexual partnerships. A study that tracks men with recent HIV infection and their partners over time can provide information key to stopping further spread of HIV given that sexual behaviors can vary over time, especially during this most infectious period.
This study will look at how likely it is for HIV infection to be spread among partner types over time by recently HIV-infected men and their partners. The study will compare behaviors of recently HIV infected men to those with long-term HIV infection and no HIV infection. It will allow a study of sexual partnerships by actively recruiting sexual partners. We will also focus on the role of drug use, especially methamphetamine and how it changes behaviors over time. We will especially look at how different sex partners affects one's drug use and increases or decreases HIV transmission. The study will enroll 150 recently HIV-infected men who have sex with men and follow them for a year. In addition, up to 6 sexual partners of each recently HIV infected individual will be recruited and followed for a year. Some sexual partners will be HIV negative and some HIV positive. We will use their HIV status to compare behaviors over time in the group and between partners of the same status and partners of a different status. The results will be used in special formulas that will allow for a better understanding of behavior change by men with recent HIV infection. This new information will be key for designing new ways to target risk reduction for recently HIV-infected men.
- Conditions
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV- | This study measured how transmission risks and partnership dynamics change over time among recently HIV-infected individuals and their partners comparing their behavioral patterns with those with chronic HIV infection, no HIV infection, and HIV negative testers. Of special focus was the role of drug use, especially methamphetamine, in affecting behaviors over time, and how partnership dynamics interact with drug use to allow for HIV transmission. The study compared behaviors of recently HIV infected men to those with long-term HIV infection and no HIV infection. We looked at how different types of sex partners affected one's drug use and consequently HIV transmission risks including having a prevalent sexually transmitted infection (STI). The study enrolled 105 HIV- recently tested men who have sex with men (MSM) and followed them for a year. | |
| HIV+ Acutely Infected | This study enrolled and followed 125 acutely infected HIV+ men. It measured how transmission risks and partnership dynamics change over time among recently HIV-infected individuals and their partners comparing their behavioral patterns with those with chronic HIV infection, no HIV infection, and HIV negative testers. Of special focus was the role of drug use, especially methamphetamine, in affecting behaviors over time, and how partnership dynamics interact with drug use to allow for HIV transmission. The study compared behaviors of recently HIV infected men to those with long-term HIV infection and no HIV infection. We looked at how different types of sex partners affected one's drug use and consequently HIV transmission risks including having a prevalent sexually transmitted infection (STI). The study enrolled 321 recently tested men who have sex with men (MSM) and followed them for a year. | |
| HIV+ Chronically Infected | This study enrolled and followed 91chronicially infected HIV+ men. It measured how transmission risks and partnership dynamics change over time among recently HIV-infected individuals and their partners comparing their behavioral patterns with those with chronic HIV infection, no HIV infection, and HIV negative testers. Of special focus was the role of drug use, especially methamphetamine, in affecting behaviors over time, and how partnership dynamics interact with drug use to allow for HIV transmission. The study compared behaviors of recently HIV infected men to those with long-term HIV infection and no HIV infection. We looked at how different types of sex partners affected one's drug use and consequently HIV transmission risks including having a prevalent sexually transmitted infection (STI). The study enrolled 321 recently tested men who have sex with men (MSM) and followed them for a year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure how HIV transmission risks change over time among recently HIV-infected individuals and their partners
This study will compare behavioral patterns of recently HIV infected individuals with those with chronic HIV infection and no HIV infection. It will allow for partnership level analyses by actively recruiting sexual partners.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startFeb 2009
- Primary completionMar 2018
- Study completionAug 2018
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 California, Los AngelesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Responsible party
- Principal investigator, Pamina Gorbach, University of California, Los Angeles
- Investigators
- Pamina M. Gorbach, DrPh, Principal investigator, UCLA/EPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201083
- Sponsor's protocol ID
- R01DA022116 - A1
- Other IDs
- G07-06-117-03, R01DA022116
- Acronym
- MetroMates
- Status last verified
- Apr 2019
- First submitted
- 9 Sep 2010
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Murray CH, Javanbakht M, Cho GD, Gorbach PM, Fulcher JA, Cooper ZD. Changes in Immune-Related Biomarkers and Endocannabinoids as a Function of Frequency of Cannabis Use in People Living With and Without HIV. Cannabis Cannabinoid Res. 2024 Jun;9(3):e897-e906. doi: 10.1089/can.2022.0287. Epub 2023 Apr 20.
PubMed 37093248
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmission Behavior in Partnerships of Newly HIV Infected Southern Californians
- ClinicalTrials.gov ID
- NCT01201083
- Acronym / sponsor ID
- MetroMates / R01DA022116 - A1
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Study start
- Feb 2009 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 14 Sep 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.
Identify drug use patterns and partnership dynamics that mediate risk behaviors over time in a cohort of recently HIV infected men and their partners; to determine predictors of transmission risk within partnerships of recently HIV infected men and their partners, using the partnership as the unit of analysis; and to quantify the long-term population-level impacts of voluntary behavior change by men with recent HIV infection, through the use of dynamic mathematical modeling that integrates our data on behavior change with current estimates of temporal infectiousness patterns. The investigators will also determine whether more frequent testing and/or development of tests with earlier sensitivity may have a significant impact on the epidemic. Finally, the magnitude of this effect to that obtained by decreasing drug use or risky sexual behavior prior to or following seroconversion will be compared. This will be conducted as a statistical analysis by co-investigators at the University of Washington.
Detailed description
People who recently became infected with HIV often have a high level of the virus and may be highly infectious. If they have sex (especially anal intercourse) without condoms soon after they have been infected with HIV, there is a great chance that they may transmit the virus to others. When they learn of their HIV infection, some but not all men change sexual behaviors so as not to infect their partner(s) with HIV. Possible reasons for such behavior change include increase or decrease in drug use and what is going on within their sexual partnerships. A study that tracks men with recent HIV infection and their partners over time can provide information key to stopping further spread of HIV given that sexual behaviors can vary over time, especially during this most infectious period.
This study will look at how likely it is for HIV infection to be spread among partner types over time by recently HIV-infected men and their partners. The study will compare behaviors of recently HIV infected men to those with long-term HIV infection and no HIV infection. It will allow a study of sexual partnerships by actively recruiting sexual partners. We will also focus on the role of drug use, especially methamphetamine and how it changes behaviors over time. We will especially look at how different sex partners affects one's drug use and increases or decreases HIV transmission. The study will enroll 150 recently HIV-infected men who have sex with men and follow them for a year. In addition, up to 6 sexual partners of each recently HIV infected individual will be recruited and followed for a year. Some sexual partners will be HIV negative and some HIV positive. We will use their HIV status to compare behaviors over time in the group and between partners of the same status and partners of a different status. The results will be used in special formulas that will allow for a better understanding of behavior change by men with recent HIV infection. This new information will be key for designing new ways to target risk reduction for recently HIV-infected men.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV- | – | –This study measured how transmission risks and partnership dynamics change over time among recently HIV-infected individuals and their partners comparing their behavioral patterns with those with chronic HIV infection, no HIV infection, and HIV negative testers. Of special focus was the role of drug use, especially methamphetamine, in affecting behaviors over time, and how partnership dynamics interact with drug use to allow for HIV transmission. The study compared behaviors of recently HIV infected men to those with long-term HIV infection and no HIV infection. We looked at how different types of sex partners affected one's drug use and consequently HIV transmission risks including having a prevalent sexually transmitted infection (STI). The study enrolled 105 HIV- recently tested men who have sex with men (MSM) and followed them for a year. |
| HIV+ Acutely Infected | – | –This study enrolled and followed 125 acutely infected HIV+ men. It measured how transmission risks and partnership dynamics change over time among recently HIV-infected individuals and their partners comparing their behavioral patterns with those with chronic HIV infection, no HIV infection, and HIV negative testers. Of special focus was the role of drug use, especially methamphetamine, in affecting behaviors over time, and how partnership dynamics interact with drug use to allow for HIV transmission. The study compared behaviors of recently HIV infected men to those with long-term HIV infection and no HIV infection. We looked at how different types of sex partners affected one's drug use and consequently HIV transmission risks including having a prevalent sexually transmitted infection (STI). The study enrolled 321 recently tested men who have sex with men (MSM) and followed them for a year. |
| HIV+ Chronically Infected | – | –This study enrolled and followed 91chronicially infected HIV+ men. It measured how transmission risks and partnership dynamics change over time among recently HIV-infected individuals and their partners comparing their behavioral patterns with those with chronic HIV infection, no HIV infection, and HIV negative testers. Of special focus was the role of drug use, especially methamphetamine, in affecting behaviors over time, and how partnership dynamics interact with drug use to allow for HIV transmission. The study compared behaviors of recently HIV infected men to those with long-term HIV infection and no HIV infection. We looked at how different types of sex partners affected one's drug use and consequently HIV transmission risks including having a prevalent sexually transmitted infection (STI). The study enrolled 321 recently tested men who have sex with men (MSM) and followed them for a year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- STI/HIV testing and treatment clinic
Key inclusion criteria (1 listed)
- 18 years of age or older Male Documented HIV infection that occurred within previous 12 months Willing to complete study procedures Mentally competent to give informed consent Willingness to refer partners to study Ability to complete practice questions for the web-based system
Key exclusion criteria (3 listed)
- Less than 18 years of age No report of sex with another man in the past 12 months
- Unwilling to complete study follow-up questionnaires Not mentally competent to understand study procedures and give informed consent Unwilling to provide an email address or create one for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To measure how HIV transmission risks change over time among recently HIV-infected individuals and their partners
Time frame: 12 months
This study will compare behavioral patterns of recently HIV infected individuals with those with chronic HIV infection and no HIV infection. It will allow for partnership level analyses by actively recruiting sexual partners.
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 18 Apr 2019.
- Derived from this study: PubMed 37093248Murray CH, Javanbakht M, Cho GD, Gorbach PM, Fulcher JA, Cooper ZD. Changes in Immune-Related Biomarkers and Endocannabinoids as a Function of Frequency of Cannabis Use in People Living With and Without HIV. Cannabis Cannabinoid Res. 2024 Jun;9(3):e897-e906. doi: 10.1089/can.2022.0287. Epub 2023 Apr 20.
- MetroMates Study WebsiteLink provided by the sponsor.
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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.
Pamina M. Gorbach, DrPh principal investigator
UCLA/EPI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of California, Los Angeles 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 1 inclusion and 3 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 18 Apr 2019. 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.
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?
To measure how HIV transmission risks change over time among recently HIV-infected individuals and their partners (time frame: 12 months). 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 NCT01201083, 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 18 Apr 2019.