Implementation of an Efficacious Intervention for High Risk Women in Mexico
26. maj 2015 opdateret af: Thomas L. Patterson, University of California, San Diego
This project seeks to determine the personal and organizational conditions that are most conducive to the widespread adoption by community-based organizations (CBOs) of effective programs for reducing the spread of HIV and other sexually transmitted infections (STIs).
Taking a brief, single-session counseling program (called "Mujer Segura") that has been proven effective in reducing HIV and STIs in female sex workers who work in Mexican cities along the U.S. border, this project will study the implementation of the program in CBOs in 12 additional cities throughout Mexico to determine how best to ensure that the program remains true to the original model and retains its effectiveness.
Mexico has been chosen because HIV is a global problem that respects no international borders, and because HIV prevention programs that can be implemented in settings with limited resources are urgently needed in many parts of the world.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1228
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Veracruz, Mexico, 91910
- CSM Veracruz
-
-
D.f.
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Mexico City, D.f., Mexico, 06080
- Centro de Servicios Medicos (CSM) Revolucion
-
-
Jalisco
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Guadalajara, Jalisco, Mexico, 44270
- CSM Guadalajara
-
-
Veracruz
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Naranjos, Veracruz, Mexico, 92300
- CSM Naranjos
-
-
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- At least 18 years of age
- Self-identify as female sex worker
- Exchanged sex for money, drugs, shelter, or other benefit in last 2 months
- Had unprotected anal or vaginal sex with male client at least once in last 2 months
- Agree to be tested for HIV & STIs at baseline and 6-month follow-u0
Exclusion Criteria:
- Previous positive HIV test result
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Theory-based counseling (Mujer Segura)
Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.
|
Brief (35-minute) counseling intervention using techniques from Motivational Interviewing and principles of social cognitive theory (SCT) and theory of reasoned action (TRA).
|
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Aktiv komparator: CENSIDA counseling program (didactic)
Will consist of 40 FSWs at each of 12 clinics, randomized into this condition from a pool of 80 eligible participants.
|
Didactic HIV and STI counseling involving some personal risk assessment and presenting appropriate information on methods of transmission and for avoiding or reducing the risk of infection.
Based on a counseling manual disseminated by CENSIDA, Mexico's federal HIV-AIDS prevention agency.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reduction in HIV and STI incidence relative to control group
Tidsramme: 6 months
|
Female sex worker (FSW) participants will be tested at baseline and 6-month follow-up for HIV, syphilis, gonorrhea, and Chlamydia.
Incidence rates for all infections at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
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6 months
|
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Reduction in number of unprotected sex acts relative to control group
Tidsramme: 6 months
|
Female sex worker (FSW) participants will be assessed at baseline and 6-month follow-up using self-report measures of frequency of protected and unprotected sex acts with male clients.
Changes in frequency at 6-month follow-up will be compared between the theory-based Mujer Segura group (N=40 per clinic) and the standard counseling group (N=40 per clinic).
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fidelity to Mujer Segura intervention model
Tidsramme: 6 months
|
Counselors at each CBO will be assessed for their fidelity to the intervention protocol and assigned a numerical score.
This number will be used to determine possible correlations between levels of fidelity and the efficacy of the Mujer Segura intervention at each clinic.
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Thomas L Patterson, Ph.D., University of California, San Diego
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
- Pitpitan EV, Semple SJ, Aarons GA, Palinkas LA, Chavarin CV, Mendoza DV, Magis-Rodriguez C, Staines H, Patterson TL. Factors associated with program effectiveness in the implementation of a sexual risk reduction intervention for female sex workers across Mexico: Results from a randomized trial. PLoS One. 2018 Sep 11;13(9):e0201954. doi: 10.1371/journal.pone.0201954. eCollection 2018.
- Patterson TL, Semple SJ, Chavarin CV, Mendoza DV, Santos LE, Chaffin M, Palinkas LA, Strathdee SA, Aarons GA. Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors. Implement Sci. 2012 Oct 29;7:105. doi: 10.1186/1748-5908-7-105.
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. november 2011
Primær færdiggørelse (Faktiske)
1. april 2015
Studieafslutning (Faktiske)
1. april 2015
Datoer for studieregistrering
Først indsendt
2. november 2011
Først indsendt, der opfyldte QC-kriterier
4. november 2011
Først opslået (Skøn)
6. november 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. maj 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. maj 2015
Sidst verificeret
1. maj 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01MH087054 (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 .