Chronic Hepatitis B: reaching patients through their physicians
Global diagnostics manufacturer · anti-HBc Total serology collection · first collection at 2 community clinics
The challenge the client gave us
A top-tier diagnostics manufacturer needed blood specimens from patients with chronic Hepatitis B to verify a serology marker (anti-HBc Total) — roughly 100 qualified subjects from the communities where the disease actually concentrates.
The catch: chronic Hepatitis B is followed at community clinics, not academic centers. In the U.S. it runs far above baseline in Asian-American populations — so the patients sit behind the doors of the physicians who already care for them, and often behind a language barrier at the point of consent.
At a glance
| Subjects enrolled (first collection) | 104 |
| Qualified | 102 of 104 (98%) |
| Sites | 2 community clinics |
| Peak month | +63 (June 2025) |
Timeline
- Apr 2025 First collection opens (5 enrolled)
- Jun 2025 Peak month (+63)
- Jul 2025 First collection closes: 104 enrolled, 102 qualified
- After close Sponsor assay work finds high chronic Hep B marker prevalence; high sample quality brings them back for a second and third collection
What we did as a CRO
| CRO responsibility | What RDI did on this study |
|---|---|
| Regulatory & study start-up | Full-service CRO for a community-clinic chronic-HBV collection |
| Site selection & feasibility | Anchored on 2 community clinics with established chronic-HBV panels; targeted physicians serving Asian-American communities, where chronic HBV prevalence is highest |
| Site activation & training | SIVs including eligibility-enforcement training (confirming chronic status, not just a positive marker) |
| Recruitment & enrollment | Enforced eligibility at the screening front door; provided translator / language support so non-English-speaking patients could be consented and enrolled |
| Kits, samples & lab | Kit supply and specimen handling for serology collection |
| Monitoring & data | Central monitoring; tracked qualified-subject ratio weekly against the chronic-infection criterion |
| Project management & close-out | Delivered a first collection so strong on prevalence and sample quality that the sponsor came back for a second and third collection |
What made it hard
- The patients aren't where academic networks reach. Chronic Hepatitis B is followed at community clinics and concentrated in specific communities — so the usual site network doesn't apply.
- Language was a barrier at consent. Reaching the right patients meant being able to explain and consent them in their own language.
- A positive marker isn't enough — subjects had to meet the chronic-infection definition, which is easy to get wrong if enforced at the lab instead of at screening.
How we solved it
- Better targeting up front: we selected sites around the patients — physicians who already treat Asian-American communities with high chronic-HBV prevalence.
- RDI's enrichment strategy: eligibility enforced at the front door, with translator support in the path, so the cohort was enriched for true chronic infection rather than casual marker positives.
- 98% qualified at first-collection close — avoiding costly rejection at the lab back door.
The result
The first collection closed at 102 of 104 qualified (98%). When the sponsor tested those samples, they found such a high prevalence of chronic Hepatitis B markers that they asked RDI to continue enrolling — a direct result of better targeting up front and RDI's enrichment strategy. Because of the high sample quality, they came back to us for a second and third collection.
Source: Diagnostica™ and sponsor project updates. Sponsor identity withheld; site labels anonymized. Operations report, not a clinical-results publication.