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

16. april 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

600

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90028
        • Los Angeles Gay and Lesbian Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

STI/HIV testing and treatment clinic

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To measure how HIV transmission risks change over time among recently HIV-infected individuals and their partners
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, Los Angeles

Samarbeidspartnere

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Etterforskere

  • Hovedetterforsker: Pamina M. Gorbach, DrPh, UCLA/EPI

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2009

Primær fullføring (Faktiske)

1. mars 2018

Studiet fullført (Faktiske)

1. august 2018

Datoer for studieregistrering

Først innsendt

9. september 2010

Først innsendt som oppfylte QC-kriteriene

13. september 2010

Først lagt ut (Anslag)

14. september 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • R01DA022116 - A1
  • G07-06-117-03 (Annen identifikator: UCLA)
  • R01DA022116 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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