HIVB-OK PDPHNCT07807137
City-Wide Implementation and Evaluation of the B-OK Bottles for HIV Treatment Adherence Support in the Philadelphia Ryan White Medical Case Management Network
An observational study of HIV, run by University of Pennsylvania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- B-OK Bead Bottles
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 390 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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
Who may be able to join
- 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
Who cannot join
- Unwilling or unable to provide consent for study participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Aaron Richterman, PhD contact
About this study
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.
- Conditions
- HIV
- Being tested
- B-OK Bead Bottles
- Keywords
- HIV, Visual tools, Treatment adherence, Viral suppression
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-OK Bead BottlesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical Case Managers | Medical case managers (MCMs) in Philadelphia's Ryan White-funded network Receives: Behavioral: B-OK Bead Bottles | |
| Clients living with HIV | Client are individuals who are living with HIV who receive care at one of Philadelphia's Ryan White-funded network Receives: Behavioral: B-OK Bead Bottles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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.
Measured: Every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807137
- Sponsor's protocol ID
- 26-8233
- Acronym
- B-OK PDPH
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- City-Wide Implementation and Evaluation of the B-OK Bottles for HIV Treatment Adherence Support in the Philadelphia Ryan White Medical Case Management Network
- ClinicalTrials.gov ID
- NCT07807137
- Acronym / sponsor ID
- B-OK PDPH / 26-8233
- Conditions
- HIV
- Keywords
- HIV, Visual tools, Treatment adherence, Viral suppression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Case Managers | – | Behavioral: B-OK Bead BottlesMedical case managers (MCMs) in Philadelphia's Ryan White-funded network |
| Clients living with HIV | – | Behavioral: B-OK Bead BottlesClient are individuals who are living with HIV who receive care at one of Philadelphia's Ryan White-funded network |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Unwilling or unable to provide consent for study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-OK Bead BottlesMedical 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. | Behavioural | Clients living with HIV, Medical Case Managers |
Primary outcome
HIV viral suppression
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%).
1 secondary outcome
Engagement in care
Time frame: Every 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Richterman, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teniola Egbe, MPH, MBE (215-898-2939, tegbe@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV viral suppression (time frame: Every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.