Menstruation and Anemia Research: A Community Health Study

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07832526
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 22, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Group 1-Standard of Care (SOC)
    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)
  • Other: Group 2-SOC and Education/CHW input
    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

Primary Outcome Measure

Hemoglobin levels (group level change) [ Time Frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Arthi Ramakrishnan, MS
[email protected]
734-615-8068
Erica Marsh, MD, MSCI, FACOG (PRINCIPAL_INVESTIGATOR)
Community Health and Social Service Centers (CHASS)DetroitMichigan48209
Felix Valbuena, Jr, MD
[email protected]
313-644-1500
Felix Valbuena, MD (PRINCIPAL_INVESTIGATOR)

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University of Michigan· Ann Arbor, MICommunity Health and Social Service Centers (CHASS)· Detroit, MI

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