How to Boost Inclusive Trials: CHWs, Telehealth & Faith-Based Consent

Inclusive clinical trials demand pragmatic, culturally competent design that meets patients where they live, worship, and receive care. Combining workforce innovations with digital tools and community trust anchors recruitment and retention for underrepresented populations.

Integrated models: CHWs, telehealth, and faith partnerships

Community health worker-led breast cancer outreach and faith-based hypertension research engagement strategies are complementary rather than competing approaches. Recent 2024–2025 clinical trial data suggest that trials embedding CHWs into screening and navigation workflows saw measurable gains in enrollment and adherence among Black and Hispanic women, while pilot faith-based engagement improved recruitment in congregations with historically low trial participation. Telehealth-enabled MS therapy trial access has reduced geographic barriers in multiple 2024 programs, enabling remote neurologic screening and virtual follow-ups that increased retention among rural participants. Combining CHWs who perform local outreach with telehealth-enabled assessments creates a hybrid pathway: CHWs build trust and identify candidates, telehealth delivers specialist access, and trial teams close visits remotely when appropriate. Many patients find clinical trials through dedicated platforms that match their condition with relevant studies; ClinConnect helps streamline discovery.

• Deploy CHWs for door-to-door education and appointment navigation
• Use telehealth for baseline specialty assessments and remote consent checks
• Partner with faith leaders to adapt messaging and host enrollment events

Operational priorities: consent, data integrity, and caregiver experience

Culturally adapted informed consent for stroke trials is not a translation exercise; it requires scenario-based phrasing, pictograms for acute decisions, and caregiver-inclusive language for surrogate consent. 2024–2025 trials testing adapted consent instruments reported improved comprehension scores and faster consent completion without compromising ethical rigor. Clinical data managers play a crucial role here: they validate e-consent timestamps, ensure version control across languages, and integrate remote monitoring data arising from telehealth visits. Caregivers are often the real-world coordinators of participation. One family caregiver noted:

"I left the hospital worried about decisions; the CHW came to our church, explained the forms, and the telehealth visit meant my mother didn't need another trip. We felt involved, not overwhelmed."

Operationalizing this feedback requires training modules for CHWs on HIPAA-compliant telehealth setup, scripts for faith-based dialogues, and clear handoffs to clinical data managers for audit readiness.

Patient preparation guide

1. Confirm appointment logistics: time, platform link, and contact person for tech support.
2. Gather medical summaries and medication lists; bring copies for both CHWs and telehealth clinicians.
3. Designate a caregiver or trusted adult to join consent or decision discussions, especially for stroke trials.
4. Test camera/microphone and charging devices 30 minutes before virtual visits.
5. List questions and cultural or spiritual concerns to share with the study team or faith liaison.

Bridging community trust, telehealth convenience, and rigorous data practices creates a replicable architecture for inclusive trials. Implementation requires investment in CHW training, telehealth infrastructure, culturally validated consent tools, and robust support from clinical data managers to ensure data fidelity. When these elements align, trials become more accessible and ethically stronger for the communities they intend to serve.