Study of Recently HIV Infected Men and Transmission Behaviors

NCT01201083 | Completed

• 3 other identifiers: R01DA022116 - A1G07-06-117-03R01DA022116
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

STI/HIV testing and treatment clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator

Study Sites (1)

Los Angeles Gay and Lesbian Center

Los Angeles, California, 90028, United States

Location

Related Publications (1)

• 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.

  PMID: 37093248 DERIVED

Related Links

• MetroMates Study Website

Biospecimen

Retention: SAMPLES WITH DNA

We collect a sample of blood/plasma and have a repository (blood) and for future analysis. After noting that subject has consented to main study as well as consenting to have his blood stored for later research purposes, appropriate research staff will direct the phlebotomist to draw and additional tube of blood (approximately 7mls of blood) into a purple cap (EDTA) tube. After processing, each sample will be securely stored at the participating site under appropriate conditions .

Study Officials

• Pamina M. Gorbach, DrPh

  UCLA/EPI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 14, 2010
• Study Start: February 1, 2009
• Primary Completion: March 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)