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Appalachian-partnerskab for at reducere uligheder (mål 2)

21. oktober 2026 opdateret af: Wake Forest University Health Sciences

Udnyttelse af kraften i peer-navigation og mHealth til at reducere sundhedsforskelle i Appalachia

By combining two strategies (i.e., peer navigation and mHealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed HIV, STI, and HCV prevention and care services among racially/ethnically diverse GBMSM and transgender women in rural Appalachia.

Study Investigators anticipate that participants in the intervention group, relative to counterparts in the delayed-intervention group, will demonstrate increased HIV, STI, and HCV testing.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This CBPR study will advance prevention science and practice through testing an innovative intervention to promote and support the use of needed HIV, STI, and HCV prevention and care services among GBMSM and transgender women; and developing priorities and recommendations to improve their health that will be disseminated to inform public health practice, research, and policy. By integrating peer navigation and mHealth strategies, the proposed study provides a unique opportunity to improve health among vulnerable, hidden, and neglected populations living in rural Appalachia. Findings from this research may inform strategies and approaches to address other health disparities in other rural populations.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

141

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Health Sciences

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

Alle

Beskrivelse

Inclusion Criteria:

  • reside in one of the rural Appalachian catchment counties
  • be ≥18 years of age
  • report being assigned male sex at birth and having had sex with at least 1 man in past 12 months
  • provide informed consent

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: intervention group

7 community health leaders; 56 social network members
Adfærdsmæssigt: Peer Navigation

First, as health advisors, community health leaders will raise awareness of HIV, STIs, and HCV and local prevention and care services and help social network members access services. Thus, the community health leader will describe to the process for HCV testing, and how providers are required to maintain confidentiality. As opinion leaders, community health leaders will reframe health-compromising and bolster health-promoting norms and expectations about testing and use of other prevention and care services.

Each community health leader will also conduct formal in-person group activities with their social network members. Our partnership decided that each community health leader will also hold at least 4 formal group sessions during the 12 months of intervention

Adfærdsmæssigt: mHealth

In addition to in-person individual and group activities, community health leaders will use mHealth platforms preferred by each social network member (i.e., Facebook , Instagram, testing, and/or GPS-based mobile apps) to communicate with them during the intervention. They will use social media to plan activities and to support use of needed prevention and care services. For example, when planning a group activity (described above), the community health leader will use social media to remind social network members about the activity and help them problem solve barriers to attending. A community health leader and social network member may also communicate "in-real-time" via social media about the process of participating in a syringe services program or accessing PrEP.
Aktiv komparator: delayed-intervention

7 community health leaders; 56 social network members
Adfærdsmæssigt: Peer Navigation

First, as health advisors, community health leaders will raise awareness of HIV, STIs, and HCV and local prevention and care services and help social network members access services. Thus, the community health leader will describe to the process for HCV testing, and how providers are required to maintain confidentiality. As opinion leaders, community health leaders will reframe health-compromising and bolster health-promoting norms and expectations about testing and use of other prevention and care services.

Each community health leader will also conduct formal in-person group activities with their social network members. Our partnership decided that each community health leader will also hold at least 4 formal group sessions during the 12 months of intervention

Adfærdsmæssigt: mHealth

In addition to in-person individual and group activities, community health leaders will use mHealth platforms preferred by each social network member (i.e., Facebook , Instagram, testing, and/or GPS-based mobile apps) to communicate with them during the intervention. They will use social media to plan activities and to support use of needed prevention and care services. For example, when planning a group activity (described above), the community health leader will use social media to remind social network members about the activity and help them problem solve barriers to attending. A community health leader and social network member may also communicate "in-real-time" via social media about the process of participating in a syringe services program or accessing PrEP.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Antal deltagere, der har testet humant immundefektvirus (HIV).
Tidsramme: baseline
baseline
Antal deltagere, der har testet seksuelt overført infektion (STI).
Tidsramme: baseline
baseline
Antal deltagere, der har testet hepatitis C-virus (HCV).
Tidsramme: baseline
baseline
Antal deltagere, der har HIV-testet
Tidsramme: umiddelbart efter intervention (12 måneder efter baseline)
umiddelbart efter intervention (12 måneder efter baseline)
Antal deltagere, der har STI-test
Tidsramme: umiddelbart efter intervention (12 måneder efter baseline)
umiddelbart efter intervention (12 måneder efter baseline)
Antal deltagere, der har HCV-test
Tidsramme: umiddelbart efter intervention (12 måneder efter baseline)
umiddelbart efter intervention (12 måneder efter baseline)
Antal deltagere, der har HIV-testet
Tidsramme: 12-måneders opfølgning (24 måneder efter baseline)
12-måneders opfølgning (24 måneder efter baseline)
Antal deltagere, der har STI-test
Tidsramme: 12-måneders opfølgning (24 måneder efter baseline)
12-måneders opfølgning (24 måneder efter baseline)
Antal deltagere, der har HCV-test
Tidsramme: 12-måneders opfølgning (24 måneder efter baseline)
12-måneders opfølgning (24 måneder efter baseline)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antal deltagere, der bruger forebyggelse - Pre-eksponeringsprofylakse (PrEP)
Tidsramme: baseline, umiddelbar post-intervention (12 måneder post-baseline) og 12-måneders opfølgning (24 måneder post-baseline).
baseline, umiddelbar post-intervention (12 måneder post-baseline) og 12-måneders opfølgning (24 måneder post-baseline).
Antal deltagere, der bruger forebyggelse - sprøjtetjenester
Tidsramme: baseline, umiddelbar post-intervention (12 måneder post-baseline) og 12-måneders opfølgning (24 måneder post-baseline).
baseline, umiddelbar post-intervention (12 måneder post-baseline) og 12-måneders opfølgning (24 måneder post-baseline).
Number of participants who use HIV care services
Tidsramme: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

Measured through self-report and medical chart abstraction
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Number of participants who use STI treatment services
Tidsramme: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

Measured through self-report and medical chart abstraction
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Number of participants who use HCV treatment services
Tidsramme: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

Measured through self-report and medical chart abstraction
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).
Number of participants who use gender-affirming care services
Tidsramme: baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

Measured through self-report and medical chart abstraction
baseline, immediate post-intervention (12 months post-baseline), and 12-month follow-up (24 months post-baseline).

Samarbejdspartnere og efterforskere

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

Sponsor

Wake Forest University Health Sciences

Samarbejdspartnere

National Institute of Nursing Research (NINR)

Efterforskere

  • Ledende efterforsker: Scott D. Rhodes, Ph.D, MPH, Wake Forest University Health Sciences

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)

1. april 2022

Primær færdiggørelse (Faktiske)

31. maj 2026

Studieafslutning (Faktiske)

31. maj 2026

Datoer for studieregistrering

Først indsendt

4. maj 2020

Først indsendt, der opfyldte QC-kriterier

4. maj 2020

Først opslået (Faktiske)

7. maj 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00065116
  • R01NR019512 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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