Menstruation and Anemia Research: A Community Health Study

NCT07832526 | Not Yet Recruiting

• 2 other identifiers: HUM00270428OT2HL158287
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anemia

Keywords

Psychosocial intervention; Surveys; Iron deficiency anemia; Hemoglobin; Menstrual health; Abnormal uterine bleeding (AUB); Community Health Worker; Community Based Participatory Research (CBPR); Health Education

Outcome Measures

Primary Outcomes (1)

• Hemoglobin levels (group level change)

  Blood samples will be obtained to measure hemoglobin levels

  Visit 1 (approximately day 1), Visit 7 (approximately day 112)

Secondary Outcomes (6)

• Hemoglobin (Hgb) values (individual change)

  Visit 1 (approximately day 1), Visit 7 (approximately day 112)

• Self-reported hemoglobin levels

  Visit 1 (approximately day 1), Visit 7 (approximately day 112)

• Anemia status awareness

  Visit 1 (approximately day 1), Visit 7 (approximately day 112)

• Knowledge of anemia

  Visit 1 (approximately day 1), Visit 7 (approximately day 112)

• Confidence in managing anemia as measured by the Perceived Competence Scale

  Visit 1 (approximately day 1), Visit 7 (approximately day 112)

Study Arms (2)

Group 1-Standard of Care (SOC)

OTHER

Participants will be notified that they are anemic and receive written/verbal information on anemia and instructed to follow up with their healthcare provider (standard care)

Behavioral: Standard of Care

Group 2-SOC and Education/CHW input

OTHER

Standard care and attend a community-based series of group-based information sessions and receive support from CHW to follow up with healthcare providers about their anemia

Behavioral: Standard of Care; Behavioral: Informational Series and follow-up support

Interventions

Standard of Care BEHAVIORAL

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

Group 1-Standard of Care (SOC); Group 2-SOC and Education/CHW input

Informational Series and follow-up support 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.

Group 2-SOC and Education/CHW input

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You 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 may not qualify 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

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Community Health and Social Service Centers (CHASS)

Detroit, Michigan, 48209, United States

Location

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency; Metrorrhagia; Health Education

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Erica Marsh, MD, MSCI

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten Trzeciak

CONTACT

734-647-0307; kioard@med.umich.edu

Arthi Ramakrishnan, MS

CONTACT

734-615-8068; MARCH-Study@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Reproductive Medicine and Obstetrics and Gynecology

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)