Study of Recently HIV Infected Men and Transmission Behaviors (MetroMates)

April 16, 2019 updated by: Pamina Gorbach, University of California, Los Angeles

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90028
        • Los Angeles Gay and Lesbian Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

STI/HIV testing and treatment clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pamina M. Gorbach, DrPh, UCLA/EPI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2009

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (Estimate)

September 14, 2010

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • R01DA022116 - A1
  • G07-06-117-03 (Other Identifier: UCLA)
  • R01DA022116 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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