- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03201510
Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa
30. november 2018 opdateret af: HIV Prevention Trials Network
HPTN 075: Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa
This study aims to determine the feasibility of recruiting and retaining men who have sex with men (MSM) in a multi-country prospective cohort study in preparation for human immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA).
Studieoversigt
Detaljeret beskrivelse
HPTN 075 is an observational cohort study.
Participants will be accrued over six months at four sites in SSA using convenience sampling strategies, with no replacement for participants lost to follow-up.
Each participant will be followed for 12 months, during which five study visits involving structured HIV behavioral assessments, medical examinations, and collection of biological samples will be conducted (including enrollment and quarterly follow-up visits).
Participants who do not complete 12 months of follow-up will be contacted to explore reasons for no longer participating.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
401
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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 44 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Men, regardless of HIV infection status, aged 18-44 years living in SSA who report anal sex with a man in the past 3 months.
Beskrivelse
Inclusion Criteria:
- Biologically male at birth, according to self-report;
- 18-44 years old (inclusive);
- Willing and able to provide informed consent;
- Willing to undergo HIV testing throughout the study and to receive those test results;
- Reporting at least one act of anal intercourse in the previous 3 months (12 weeks) with a person reported by the participant to be biologically male;
- Able to provide complete locator identification for themselves and at least two other personal contacts;
- Willing to participate in all scheduled study assessments, including specimen collection, laboratory assessments, and sample storage;
- Committing to not participate in any HIV intervention or vaccine study while participating in HPTN 075;
- Planning to remain in the study area for at least one year;
- For HIV-uninfected men: All HIV test results at the Screening visit must be non-reactive/negative;
- For HIV-infected men (up to 20 per site): All HIV test results at the Screening visit must be reactive/positive.
Men who are already on PrEP will not be excluded. Additionally, self- or other-identified transgender women and male sex workers will not be excluded. There will, however, be no specific effort to recruit these groups.
Exclusion Criteria:
- Unwilling to adhere to study procedures;
- Past or current participation in a biomedical and/or behavioral HIV/STI intervention or cohort study, including HIV vaccine studies; however, participation in local/area PrEP demonstration projects does not preclude participation in HPTN 075;
- HIV-infected men who report that they are already on ART or in HIV care;
- Any other reason or condition that in the opinion of the Investigator of Record (IOR) would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- Men who have discordant HIV test results at Screening (i.e., at least one reactive or positive result and at least one non-reactive or negative result). These men will receive HIV counseling and will be referred for further diagnostic tests and care.
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 |
Intervention / Behandling |
---|---|
Observational
Observational study
|
HPTN 075 is an observational study in sub-Saharan MSM
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Recruitment of approximately 400 participants
Tidsramme: July 2015-July 2016
|
all 4 sites must collectively recruit 400 participants
|
July 2015-July 2016
|
Retention of approximately 400 participants
Tidsramme: July 2015-July 2016
|
at least 90% of participants must be retained
|
July 2015-July 2016
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
HIV incidence
Tidsramme: July 2015-July 2017
|
Measured by HIV RNA from plasma samples
|
July 2015-July 2017
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Theodorus Sandfort, PhD, Columbia University
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 (Faktiske)
12. juni 2015
Primær færdiggørelse (Faktiske)
12. august 2017
Studieafslutning (Faktiske)
12. august 2017
Datoer for studieregistrering
Først indsendt
26. juni 2017
Først indsendt, der opfyldte QC-kriterier
26. juni 2017
Først opslået (Faktiske)
28. juni 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HPTN 075
- UM1AI068619 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRekrutteringHIV | HIV-testning | HIV-kobling til pleje | HIV behandlingForenede Stater
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationAfsluttetPartner HIV-testning | Par HIV Rådgivning | Parkommunikation | HIV-forekomstCameroun, Dominikanske republik, Georgien, Indien
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement og andre samarbejdspartnereUkendtHIV | HIV-uinficerede børn | Børn udsat for HIVCameroun
-
University of MinnesotaTrukket tilbageHIV-infektioner | HIV/AIDS | Hiv | AIDS | Aids/Hiv problem | AIDS og infektionerForenede Stater
-
CDC FoundationGilead SciencesUkendtHIV præeksponeringsprofylakse | HIV KemoprofylakseForenede Stater
-
Erasmus Medical CenterIkke rekrutterer endnuHIV-infektioner | Hiv | HIV-1-infektion | HIV I infektionHolland
-
Hospital Clinic of BarcelonaAfsluttetIntegrasehæmmere, HIV; HIV PROTEASE HÆMMERSpanien
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London og andre samarbejdspartnereRekrutteringHIV | HIV-testning | Tilknytning til plejeSydafrika
-
University of WashingtonNational Institute of Mental Health (NIMH)RekrutteringHIV-forebyggelse | HIV præeksponeringsprofylakse | ImplementeringKenya
-
University of Maryland, BaltimoreTrukket tilbageHiv | Nyretransplantation | HIV reservoir | CCR5Forenede Stater
Kliniske forsøg med Observational
-
Clinical Research Centre, MalaysiaHospital Queen Elizabeth, MalaysiaAfsluttetCovid19 | Kritisk sygMalaysia
-
Assiut UniversityUkendt
-
Seoul National University HospitalDong-A ST Co., Ltd.Ikke rekrutterer endnuCOVID-19Korea, Republikken