About this trial
The researchers 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Unwilling or unable to provide consent for study participation
Trial population
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
Trial design
Cohort
Prospective
Treatments tested in this trial
B-OK Bead Bottles
BehavioralMedical case managers clients will receive a training on how to use B-OK bottles and will be given their own B-OK bottles. B-OK bottles are visual aids case managers can use explain how HIV treatment works in the body and to help clients visualize viral suppression. The bottles explain how HIV affects a person's health and how ART reduces viral load and eliminates HIV transmission risk.
Treatment groups
Trial outcomes
Primary outcomes
HIV viral suppression
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%).
Secondary outcomes
Engagement in care
Binary; a viral load or CD4 count measured within the 6-month lookback window for the observation period.
Other outcomes
Acceptability, appropriateness, feasibility of the B-OK Bottles
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
Retention in care
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.
Adoption and penetration
Proportion of MCMs using B-OK and proportion of clients with whom it is used
Delivery quality (fidelity)
MCM self-reported delivery of core B-OK elements and a brief role-play / competency check during a post-implementation MCM interview
Locations
Sponsors and contacts
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