What this study is
This research is studying if a community-based, community health worker (CHW) led psychosocial intervention improves hemoglobin levels among Black/African American and/or Hispanic or Latino women with anemia compared to standard of care.
The intervention group will demonstrate a greater mean increase in hemoglobin at follow up than the control group. The expected treatment difference effect is a between group difference of 1.0-point or greater in mean Hgb at follow up.
What's being tested
- Standard of Care
Intervention · BEHAVIORAL
Participant will be given verbal and written information on taking iron.
- Informational Series and follow-up support
Intervention · BEHAVIORAL
The CHW-led intervention is a structured, community-based psychosocial education series for participants randomized to the intervention arm. Trained CHWs will deliver five sessions over 10 weeks covering: (1) blood and hemoglobin basics; (2) anemia and common treatments; (3) normal menstrual health; (4) abnormal uterine bleeding (AUB), including common causes and treatments; and (5) AUB across the reproductive lifespan, with review. Sessions may be in person or use another approved, accessible modality. Standardized materials and guides will support consistency while allowing questions, discussion, and culturally responsive dialogue. CHWs will help participants understand hemoglobin results, prepare questions, connect with providers or establish care, and navigate anemia-related follow-up. CHWs will not give medical advice, diagnose conditions, or prescribe treatment.
Study details
- Sponsor
- University of Michigan
- Conditions
- Anemia
- Enrolling
- 180 people
- Starts
- 2026-09
- Est. completion
- 2028-04
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 55 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Self-identify as black/African American and/or Hispanic/Latino
- Has had a menstrual period in the last 6 months
- Hemoglobin (Hgb) by point of care (POC) test is less than 12.0 g/dL and greater than or equal to 7.0 g/dL
- Able to read, write, and communicate in Spanish and/or English
You can't join if
- Received iron infusion in the past month
- Recent (within the last 4 weeks) or anticipated major surgery with anesthesia for greater than 30 minutes within the next 3 months
- Undergone Bariatric (i.e. weight-loss) Surgery including Gastric Bypass Surgery, Gastric Sleeve Surgery or other Bariatric Surgery
- Diagnosed with anemia related to a condition other than iron deficiency, such as thalassemia or sickle cell disease or are a carrier.
- Diagnosed with cancer (not including thyroid, cervical, or non-melanoma skin cancer)
- Currently or within the last 3 months experiencing bloody or black tarry stools
- Currently or within the last 3 months vomiting blood or emesis that resembles dark coffee grounds
- Currently pregnant women
- Hgb by POC test is less than 7.0 g/dL
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of Michigan
Ann Arbor, Michigan, United States
- Arthi Ramakrishnan, MS · Contact734-615-8068MARCH-Study@med.umich.edu
- Erica Marsh, MD, MSCI, FACOG · Principal investigator
Community Health and Social Service Centers (CHASS)
Detroit, Michigan, United States
- Felix Valbuena, Jr, MD · Contact313-644-1500 ext. 5015fvalbuena@chasscenter.org
- Felix Valbuena, MD · Principal investigator
Study team
Sponsor
University of Michigan
Study ID HUM00270428
Principal investigator
Erica Marsh, MD, MSCI
University of Michigan
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.