NCT Number: NCT07807137
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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%).
Time frame: Every 6 months
Binary; a viral load or CD4 count measured within the 6-month lookback window for the observation period.
Time frame: 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
Time frame: 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.
Time frame: Every 6 months
Proportion of MCMs using B-OK and proportion of clients with whom it is used
Time frame: 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
Time frame: Every 6 months
Continued use across 6- and 12-month surveys; pilot-site sustainability
Time frame: Every 6 months
Client surveys and interviews
Contact information is provided by the study sponsor or research team.
Aaron Richterman, PhD
CONTACT
Teniola Egbe, MPH, MBE
CONTACT
University of Pennsylvania
Other
Acronym: B-OK PDPH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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