An observational study in HIV, sponsored by University of Pennsylvania. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Pennsylvania · Observational
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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.
353 studies on the registry are indexed under Treatment Adherence and Compliance; 109 are open to participants now.
This study's planned enrollment of 390 is above the median of 204 across 74 observational studies indexed under Treatment Adherence and Compliance.
Browse Treatment Adherence and Compliance studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 234 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 110 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Medical case managers (MCMs) in Philadelphia's Ryan White-funded network
Behavioral: B-OK Bead Bottles
Client are individuals who are living with HIV who receive care at one of Philadelphia's Ryan White-funded network
Behavioral: B-OK Bead Bottles
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.
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
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
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
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
Adoption and penetration
Proportion of MCMs using B-OK and proportion of clients with whom it is used
Time frame: Every 6 months
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
Maintenance/sustainability
Continued use across 6- and 12-month surveys; pilot-site sustainability
Time frame: Every 6 months
Client-reported reach and value
Client surveys and interviews
Time frame: Every 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Feb 2028, 16 months later.
Of 35 observational studies under Treatment Adherence and Compliance, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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