Community and Systems-level HIV Prevention in Peru
25. april 2022 opdateret af: University of California, San Francisco
Combination HIV Prevention, Linking Prevention and Care, for Hispanic Men
This project involves adapting 3 new intervention components, and then testing them, in combination with a multi-level, community-based intervention, to promote HIV prevention and sexual health among men who have sex with men and transgender women in Lima, Peru.
The total intervention has a community-based intervention and a systems-level intervention at the hospital where people living with HIV get care and medications.
Studieoversigt
Detaljeret beskrivelse
Mpowerment (MP) is an evidence-based community-level, structural, social and behavioral intervention for HIV prevention for young men who have sex with men (MSM).
MP targets individual and community empowerment and community mobilization, self-affirmation, sexual self-knowledge and creation of a supportive and affirming social environment.
MP has been widely used in the U.S. but not in Peru, with the exception of earlier pilot research.
In the earlier research, MP was adapted for the sociocultural issues facing MSM and transgender (trans) women in Peru, and only focused risk reduction and increasing HIV testing.
In addition to the MP (which is called the community-based intervention), a health systems component has been added.
The health systems includes (1) sensitization of hospital staff (where people living with HIV obtain their medication) to the issues facing transgender women and MSM; (2) the use of Navigators, who help MSM and trans women at the hospital navigate the system of care and remain in care; and (3) a focus on "positive prevention", in which providers talk about the positive aspects of maintaining in care and being virally suppressed instead of only talking about "avoiding death."
There is a 2.5 year implementation of the intervention, called "Projecto Orgullo Plus" or Project Pride Plus, which involves a longitudinal cohort of MSM/trans in two large districts of Lima, Peru.
Primary outcomes will be unprotected anal sex and HIV testing.
Secondary outcomes will be self-reported visits to hospital for care and adherence to medications.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
458
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Lima, Peru
- Cayetano Heredia University
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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 40 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Must live in either East Lima District or South Lima District
- identify as man who has sex with men or transgender woman who has sex with men
- be between the ages of 18 - 40
Exclusion Criteria:
- not residing in either East or South District of Lima
- not MSM or transgender woman
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Generacion Actual
Generacion Actual includes Community-based and a Health Systems Components.
This multi-level intervention reaches out to all MSM/trans by mobilizing them to encourage friends to reduce risk behavior and increase HIV testing, and for HIV+ friends, encourage them to link, stay in care, and take medications regularly.
The community based component includes a leadership group, community space, community mobilization events, and group sessions to address a variety of psychosocial issues as well as HIV literacy.
The Health Systems component includes sensitization of the HIV testing and care staff to working with MSM and trans, Navigators to help MSM/trans to navigate the complex health system; and positive prevention training of providers; all evidence-based approaches.
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See description in arm description.
Andre navne:
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Ingen indgriben: Comparison
No intervention is implemented in the comparison arm.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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condomless anal sex
Tidsramme: 37 months post-baseline
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condomless anal sex with HIV+ or unknown status partners, assessed via questionnaire
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37 months post-baseline
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HIV testing ever
Tidsramme: 37 months post-baseline
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if have ever tested for HIV
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37 months post-baseline
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HIV testing frequency
Tidsramme: 37 months post-baseline
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frequency of HIV testing by report on questionnaire
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37 months post-baseline
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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If enrolled in care
Tidsramme: 37 months post-baseline
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Has the person, after testing HIV+, enroll in care
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37 months post-baseline
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Seeking regular HIV care
Tidsramme: 37 months post-baseline
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If have seen HIV provider recently by report on questionnaire
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37 months post-baseline
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Taking medications adherently
Tidsramme: 37 months post-baseline
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If have missed any times of taking HIV medications by report on questionnaire
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37 months post-baseline
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If virally suppressed
Tidsramme: 37 months post-baseline
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Has the person been told that he/she is virally suppressed
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37 months post-baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Susan M Kegeles, PhD, University of California, San Francisco
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)
6. april 2017
Primær færdiggørelse (Faktiske)
30. januar 2021
Studieafslutning (Faktiske)
30. januar 2021
Datoer for studieregistrering
Først indsendt
13. november 2018
Først indsendt, der opfyldte QC-kriterier
10. december 2018
Først opslået (Faktiske)
12. december 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 5R01MH109401-04 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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