An interventional study of Standard of Care and Informational Series and follow-up support in Anemia, sponsored by University of Michigan. Not yet recruiting at 2 sites in United States. Open to female participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 180 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Participant will be given verbal and written information on taking iron.
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.
Hemoglobin levels (group level change)
Blood samples will be obtained to measure hemoglobin levels
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Hemoglobin (Hgb) values (individual change)
Blood samples will be obtained to measure hemoglobin levels
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Self-reported hemoglobin levels
Self reported hemoglobin value
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Anemia status awareness
Number of participants who answered correctly, "Is your hemoglobin value normal (i.e. not anemic)?
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Knowledge of anemia
Anemia knowledge is measured using a 20-item anemia knowledge assessment. Scores range from 0-20 and higher scores indicate greater anemia knowledge.
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Confidence in managing anemia as measured by the Perceived Competence Scale
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.
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Knowledge of Abnormal uterine bleeding (AUB)/menstrual health based on knowledge assessment
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.
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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