Menstruation and Anemia Research: A Community Health Study

ConditionAnemia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age21-55

SponsorUniversity of Michigan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

180 Participants

are divided into 2 treatment groups

Group A: Group 1-Standard of Care (SOC)Other 1 intervention

Group B: Group 2-SOC and Education/CHW inputOther 2 interventions

Trial outcomes