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NCT07832526
Menstruation and Anemia Research: A Community Health Study
Conditions: Anemia
Sex: Female
Ages: 21 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 180
Sponsor: University of Michigan
Location: University of Michigan Ann Arbor Michigan
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Self-identify as black/African American and/or Hispanic/Latino
2. Has had a menstrual period in the last 6 months
3. 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
4. Able to read, write, and communicate in Spanish and/or English
Exclusion Criteria:
1. Received iron infusion in the past month
2. Recent (within the last 4 weeks) or anticipated major surgery with anesthesia for greater than 30 minutes within the next 3 months
3. Undergone Bariatric (i.e. weight-loss) Surgery including Gastric Bypass Surgery, Gastric Sleeve Surgery or other Bariatric Surgery
4. Diagnosed with anemia related to a condition other than iron deficiency, such as thalassemia or sickle cell disease or are a carrier.
5. Diagnosed with cancer (not including thyroid, cervical, or non-melanoma skin cancer)
6. Currently or within the last 3 months experiencing bloody or black tarry stools
7. Currently or within the last 3 months vomiting blood or emesis that resembles dark coffee grounds
8. Currently pregnant women
9. Hgb by POC test is less than 7.0 g/dL
Source: ClinicalTrials.gov (NCT07832526). StuddyBuddy aggregates publicly available trial information.