Menstruation and Anemia Research: A Community Health Study

N/ANot Yet RecruitingNCT07832526

University of Michigan180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

180

Conditions

Anemia

Interventions

Standard of CareBEHAVIORAL

Participant will be given verbal and written information on taking iron.

Informational Series and follow-up supportBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Michigan

Ann Arbor, Michigan, United States

Community Health and Social Service Centers (CHASS)

Detroit, Michigan, United States