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Understanding Substance Use and Incident HIV/STI Among Young Black MSM

25. juni 2019 opdateret af: Patrick S Sullivan, Emory University

Understanding Substance Use and Incident HIV/STI Among Young Black Men Having Sex With Men (MSM)

The scientific purpose of this study is to look at how substance use may relate to human immunodeficiency virus (HIV) infection among young black men who have sex with men in Atlanta.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Young black men who have sex with men (YBMSM) are a critically at-risk population in the United States and Atlanta that faces extremely high incidence rates of HIV and other sexually transmitted infections (STIs). The understanding of what places this group of men at high risk is incomplete, and the role of substances in amplifying that risk is unclear. This study will fill a number of gaps about how substances and partnerships place YBMSM at increased HIV risk. The study includes several innovative aspects. First, the investigators are using a theoretical framework to understand multilevel associations between substance use and HIV risk behavior in YBMSM in the southeastern United States, a critically at-risk but understudied population. Second, the investigators are using a variety of enhanced measurement methods to understand these associations. The investigators are supplementing self-reported substance use with objective measures to enhance the sensitivity of classifying recent use. The investigators will analyze incident HIV/STI endpoints in addition to self-reported sexual behaviors. The investigators will use detailed, event-based and dyadic measures of substance use and its covariates, which will capture both sexual and non-sexual contexts of use. Although previous cohort studies have explored alcohol and drug use during sexual events among men who have sex with men (MSM), few studies have described both sexual and non-sexual patterns of, and motivations for, substance use among YBMSM, and none have incorporated longitudinal biomarkers of substance use and related these to incident infection outcomes. Finally, the investigators are using a mixed-methods approach to provide context to the quantitative findings. By recruiting subjects to a nested qualitative study within the larger cohort based on their interval-specific risks, the investigators will gain in-depth information regarding the emergence, persistence, and resolution of these complex relationships between substances and sexual risk behaviors among YBMSM and how these relationships emerge and are resolved over time.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

469

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30303
        • Grady Health System
      • Atlanta, Georgia, Forenede Stater, 30322
        • Rollins School of Public Health
      • Atlanta, Georgia, Forenede Stater, 30308
        • Grady Infectious Diseases Clinic (Ponce Clinic)
      • Atlanta, Georgia, Forenede Stater, 30308
        • The Ponce de Leon Center of the Grady Health System
      • Atlanta, Georgia, Forenede Stater, 30309
        • AID Atlanta
      • Atlanta, Georgia, Forenede Stater, 30315
        • Southside Medical Center
      • Atlanta, Georgia, Forenede Stater, 30331
        • SisterLove, Inc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 29 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Young black men who have sex with men in Atlanta, Georgia will be recruited in a variety of venues in Atlanta. If needed, there will be targeted recruitment via Facebook.

Beskrivelse

Inclusion Criteria:

  • male at birth
  • currently identifies as male
  • age ≥18 years and < 30 years at enrollment
  • had anal sex with a man in lifetime
  • has had any sex with a man in the past 3 months
  • self-reported race is black/African American
  • lives in Atlanta area and plans to remain for 2 years
  • is able to complete the survey instruments in English
  • is willing to provide at least 2 means of contact
  • is willing to be re-contacted for the return of HIV/STI testing results, and for other study reasons as necessary
  • is not enrolled in an HIV prevention trial

Exclusion Criteria:

  • self-reported multiple or non-Black/African American race(s)
  • self-reported Hispanic ethnicity
  • (for prospective follow-up) participant screens HIV-positive

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
HIV-negative YBMSM
Subjects are young black men who have sex with men in Atlanta, Georgia and are HIV-negative
HIV-positive YBMSM
Subjects are young black men who have sex with men in Atlanta, Georgia and are HIV-positive

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hazard ratio for HIV incidence and levels of alcohol, marijuana, cocaine, and ecstasy use
Tidsramme: 2 years
Prevalence of drug use and association between these factors and HIV seroconversion (hazard ratio)
2 years
Incidence rates of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use
Tidsramme: 2 years
2 years
Proportion of recent sex partners who are additionally substance-use partners
Tidsramme: 2.5 years
2.5 years
Incidence rates of HIV
Tidsramme: 2 years
Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Event-level odds ratios between serodiscordant unprotected anal intercourse and self-reported alcohol, marijuana, cocaine, and ecstasy use
Tidsramme: 2.5 years
2.5 years
Incidence rates of sexually transmitted infections (rectal gonorrhea, rectal chlamydia, urethral gonorrhea, urethral chlamydia, syphilis)
Tidsramme: 2 years
Total person-years will be calculated as the time from study entry to the estimated date of seroconversion.
2 years
Rate ratios between sexually transmitted infection (STI) incidence and levels of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use
Tidsramme: 2 years
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Emory University

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)

Efterforskere

  • Ledende efterforsker: Patrick S Sullivan, DVM, PhD, Emory University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2015

Primær færdiggørelse (Faktiske)

18. marts 2019

Studieafslutning (Faktiske)

18. marts 2019

Datoer for studieregistrering

Først indsendt

17. juli 2015

Først indsendt, der opfyldte QC-kriterier

17. juli 2015

Først opslået (Skøn)

21. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00078950
  • 1R01DA038196-01 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Romania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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