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City-Wide Implementation and Evaluation of the B-OK Bottles for HIV Treatment Adherence Support in the Philadelphia Ryan White Medical Case Management Network (B-OK PDPH)

2. september 2026 opdateret af: University of Pennsylvania
We will conduct a hybrid implementation-effectiveness study of a city-wide B-OK rollout led by PDPH with research and evaluation support from the University of Pennsylvania. The rollout uses a randomized stepped-wedge design across the 21 MCM sites that have not previously received B-OK. The four pilot sites that received bottles without structured training in late 2023 will now also receive the full package and be trained but be analyzed as a separate stratum given prior exposure. The evaluation is organized under RE-AIM, with implementation outcomes defined using Proctor's taxonomy and contextual determinants assessed using CFIR.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

390

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Clients: individuals living with HIV that receive case management from one of the 25 agencies that received Ryan White funding for HIV medical case management in Philadelphia in 2025

MCM: Case managers that work at the 25 agencies that received Ryan White funding for HIV medical case management in Philadelphia in 2025

Beskrivelse

Inclusion Criteria:

  • Medical Case Managers (MCM) from the 25 agencies that received Ryan White funding for HIV medical case management in Philadelphia in 2025
  • Clients living with HIV that receive case management from one of the 25 agencies that received Ryan White funding for HIV medical case management in Philadelphia in 2025

Exclusion Criteria:

  • Unwilling or unable to provide consent for study participation

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
Medical Case Managers
Medical case managers (MCMs) in Philadelphia's Ryan White-funded network
Adfærdsmæssigt: B-OK Bead Bottles
People will receive information about HIV and ART that is communicated using B-OK bottles as visual aids to make the information more salient. The bottles explain how HIV affects a person's health and how ART reduces viral load and eliminates HIV transmission risk.
Clients living with HIV
Client are individuals who are living with HIV who receive care at one of Philadelphia's Ryan White-funded network
Adfærdsmæssigt: B-OK Bead Bottles
People will receive information about HIV and ART that is communicated using B-OK bottles as visual aids to make the information more salient. The bottles explain how HIV affects a person's health and how ART reduces viral load and eliminates HIV transmission risk.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HIV viral suppression
Tidsramme: Every 6 months
Binary, assigned to each client active at a participating site as of the end of each two-month (bimonthly) observation period. A client is classified as virally suppressed for a period if they had at least one viral load measured during the 6 months ending at the close of that period and the most recent such viral load was <200 copies/mL; clients with no viral load measured during that 6-month window are classified as not suppressed. This is consistent with the PDPH surveillance definition of viral suppression and allows every active client to be classified in every period (baseline city average 74.4%).
Every 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Engagement in care
Tidsramme: Every 6 months
Binary; a viral load or CD4 count measured within the 6-month lookback window for the observation period.
Every 6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptability, appropriateness, feasibility of the B-OK Bottles
Tidsramme: Every 6 months
Implementation outcomes will be summarized descriptively overall and by site, time point, and stratum (pilot vs. newly trained). AIM/IAM/FIM scores and usage/penetration measures will be compared across the three survey time points and between the passive-dissemination (pilot baseline) and structured-training conditions
Every 6 months
Retention in care
Tidsramme: Every 12 months
Two or more laboratory results ≥91 days apart within a calendar year (PDPH surveillance definition; baseline 59.4%), analyzed based on a 12-month lookback for each observation period.
Every 12 months
Adoption and penetration
Tidsramme: Every 6 months
Proportion of MCMs using B-OK and proportion of clients with whom it is used
Every 6 months
Delivery quality (fidelity)
Tidsramme: Every 6 months
MCM self-reported delivery of core B-OK elements and a brief role-play / competency check during a post-implementation MCM interview
Every 6 months
Maintenance/sustainability
Tidsramme: Every 6 months
Continued use across 6- and 12-month surveys; pilot-site sustainability
Every 6 months
Client-reported reach and value
Tidsramme: Every 6 months
Client surveys and interviews
Every 6 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Pennsylvania

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 (Anslået)

20. oktober 2026

Primær færdiggørelse (Anslået)

28. februar 2028

Studieafslutning (Anslået)

31. marts 2029

Datoer for studieregistrering

Først indsendt

2. september 2026

Først indsendt, der opfyldte QC-kriterier

2. september 2026

Først opslået (Faktiske)

8. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26-8233

Plan for individuelle deltagerdata (IPD)

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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 .

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