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

ConditionHIV
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • B-OK Bead Bottles

    Behavioral

    Medical 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

390 Participants
are divided into 2 treatment groups
Group A: Medical Case Managers1 intervention
Group B: Clients living with HIV1 intervention

Trial outcomes

Primary outcomes

1

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%).

Time frame
Every 6 months

Secondary outcomes

1

Engagement in care

Binary; a viral load or CD4 count measured within the 6-month lookback window for the observation period.

Time frame
Every 6 months

Other outcomes

1

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

Time frame
Every 6 months
2

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.

Time frame
Every 12 months
3

Adoption and penetration

Proportion of MCMs using B-OK and proportion of clients with whom it is used

Time frame
Every 6 months
4

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

Time frame
Every 6 months

Locations

This trial has no locations.

Sponsors and contacts

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