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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07807137
Acronym
B-OK PDPH
Enrollment
390
Registered
2026-09-08
Start date
2026-10-20
Completion date
2029-03-31
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv, HIV Treatment, Undetectable = Untransmittable, U=U

Keywords

HIV, Visual tools, Treatment adherence

Brief summary

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.

Interventions

BEHAVIORALB-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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
HIV viral suppressionEvery 6 monthsBinary, 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%).

Secondary

MeasureTime frameDescription
Engagement in careEvery 6 monthsBinary; a viral load or CD4 count measured within the 6-month lookback window for the observation period.

Contacts

CONTACTTeniola Egbe, MPH, MBE
tegbe@pennmedicine.upenn.edu215-898-2939
CONTACTAaron Richterman, PhD
Aaron.Richterman@Pennmedicine.upenn.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026