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NCT Number: NCT07832526

Menstruation and Anemia Research: A Community Health Study

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.

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Key information

Conditions

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

Age range

21 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Standard of Care

Behavioral

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

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.

Primary outcomes

  1. Hemoglobin levels (group level change)

    Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)

    Blood samples will be obtained to measure hemoglobin levels

Secondary outcomes

  1. Hemoglobin (Hgb) values (individual change)

    Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)

    Blood samples will be obtained to measure hemoglobin levels

  2. Self-reported hemoglobin levels

    Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)

    Self reported hemoglobin value

  3. Anemia status awareness

    Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)

    Number of participants who answered correctly, "Is your hemoglobin value normal (i.e. not anemic)?

  4. Knowledge of anemia

    Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)

    Anemia knowledge is measured using a 20-item anemia knowledge assessment. Scores range from 0-20 and higher scores indicate greater anemia knowledge.

  5. Confidence in managing anemia as measured by the Perceived Competence Scale

    Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)

    Perceived Competence Scale is a 4-item questionnaire and assesses participants feelings of competence engaging in a behavior. It is calculated by averaging a person's score of the 4 items. Higher scores indicate greater levels of perceived capability in the relevant domain.

  6. Knowledge of Abnormal uterine bleeding (AUB)/menstrual health based on knowledge assessment

    Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)

    10-item menstrual health knowledge assessment. Scores range from 0-20 and higher scores indicate greater anemia knowledge. Scores range from 0-10 and higher scores indicate greater menstrual health knowledge.

Study contacts

Contact information is provided by the study sponsor or research team.

Arthi Ramakrishnan, MS

CONTACT

[email protected]

734-615-8068

Kirsten Trzeciak

CONTACT

[email protected]

734-647-0307

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: MARCH

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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