Navigation Study: Durham (NCT04438031)
Evaluation of the Navigation Prevention Program: Durham
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this RCT is to evaluate the implementation and impact of a new, community-wide prevention program, "Community Navigation", on maternal and child health and well-being. This program recruits mothers at the OB/GYN or pediatrician's office prenatally and provides up to six Navigation visits (prenatally, and at child ages 12, 24, 36, 48, and 60 months) to assess family strengths and needs, establish connections between the family and primary health care or other community providers based on identified needs and family preference, and then follows up one month later to confirm these referrals.
Who can join: Review the eligibility criteria below.
Location: Duke University — Durham, North Carolina
Age range: 0 Years
🧪 Interventions in This Study
- Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used) (BEHAVIORAL)
- Control Intervention (BEHAVIORAL)
- Navigation Intervention Version 2.0 (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Duke University — Durham, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Prenatal; Postnatal clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.