En søg, test og behandl intervention for at reducere Chlamydia Trachomatis-forskelle
En søg, test og behandle intervention for at reducere Chlamydia Trachomatis-forskelle hos sorte unge, der bor i det dybe syd
This study includes testing for four STIs (chlamydia, gonorrhea, syphilis, and HIV) at no cost. If positive, individual subjects will also be counseled and offered options for treatment for themselves and their sex partners that may include no cost expedited treatment and the option to be rescreened 3 months after treatment.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Patricia Kissinger, PhD
- Telefonnummer: 504-988-7320
- E-mail: kissing@tulane.edu
Studiesteder
-
-
Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Rekruttering
- Tulane University Celia Scott Weatherhead School of Public Health and Tropical Medicine
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Kontakt:
- Momi Sagoe, MPH
- Telefonnummer: 504-988-1049
- E-mail: msagoe@tulane.edu
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Kontakt:
- Patricia Kissinger, PhD
- Telefonnummer: 504-988-7320
- E-mail: kissing@tulane.edu
-
Ledende efterforsker:
- Patricia Kissinger, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Identifies as African American or Black
- 15-26 years of age
- Lives or spends most of their time in Orleans Parish
- Had vaginal sex at least once
- Provide a urine or vaginal swab
- Not taken azithromycin or cefixime in the last 7 days
Exclusion Criteria:
- Unwilling or unable to provide informed consent
- Unable to speak or understand English
- Previously enrolled in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Chlamydia, gonorrhea, syphilis, and HIV screening
Community screening of individuals for chlamydia and gonorrhea is not normally done. We are testing to see if this intervention will impact the rates of chlamydia among women. |
Individuals aged 15-26 years old will be tested for chlamydia, gonorrhea, HIV, and syphilis at community based venues. Individuals who test positive for chlamydia and gonorrhea and their sexual partners will be offered expedited treatment at participating pharmacies. Individuals who test positive will be asked to be rescreened for Ct/GC at 3 months post treatment. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of chlamydia in women
Tidsramme: up to 60 months
|
Primary outcome |
up to 60 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Index participant medication pickup rate
Tidsramme: up to 60 months
|
Percentage of index participants who obtain their prescribed medication from a partnering pharmacy among all index participants who report intending to pick up the medication. Medication receipt will be determined from pharmacy billing records. Rates will be calculated monthly. |
up to 60 months
|
|
Partner medication pickup rate
Tidsramme: 60 months
|
Percentage of partners who obtain their prescribed medication from a partnering pharmacy among all partners reported as intending to pick up the medication. Medication receipt will be determined from pharmacy billing records. Rates will be calculated monthly. |
60 months
|
|
Self reported treatment of index participants and partners
Tidsramme: 60 months
|
Number and percentage of index participants who report that they and all applicable partner(s) received treatment. The denominator will include index participants who provide follow-up information about their own and their partner(s)' treatment status. |
60 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Blodbårne infektioner
- Urogenitale sygdomme
- Genitale sygdomme
- Sygdomme i immunsystemet
- Infektioner
- RNA-virusinfektioner
- Virussygdomme
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Langsomme virussygdomme
- Bakterielle infektioner
- Bakterielle infektioner og mykoser
- Gram-negative bakterielle infektioner
- Spirochaetales infektioner
- HIV-infektioner
- Chlamydiaceae infektioner
- Seksuelt overførte sygdomme, bakteriel
- Neisseriaceae infektioner
- Treponemal infektioner
- Erhvervet immundefektsyndrom
- Klamydia infektioner
- Gonoré
- Syfilis
- Undersøgelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Mikrobiologiske teknikker
- HIV -test
Andre undersøgelses-id-numre
- 2024-377
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
We will provide de-identified data to persons who submit a reasonable request with appropriate institutional approval after the primary and secondary request questions have been published.
IPD-delingstidsramme
IPD and supporting information will be available from 2030 to 2033 (3 years).
IPD-delingsadgangskriterier
Any person with IRB approval from their institution who has a coherent plan for analysis can be provided with a CSV file and coding guide in a de-identified format.
IPD-deling Understøttende informationstype
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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