AnemiaMARCHNCT07832526
Menstruation and Anemia Research: A Community Health Study
A study testing Informational Series and follow-up support in people with Anemia, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years, women only
- Conditions the study is for
- Anemia
- What is being tested?
- Informational Series and follow-up support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Arthi Ramakrishnan, MS, 734-615-8068, MARCH-Study@med.umich.edu
Erica Marsh, MD, MSCI, FACOG
Community Health and Social Service Centers (CHASS)
Detroit, Michigan, 48209
Felix Valbuena, Jr, MD, 313-644-1500 ext. 5015, fvalbuena@chasscenter.org
Felix Valbuena, MD
About this 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.
- Conditions
- Anemia
- Being tested
- Standard of Care, Informational Series and follow-up support
- Keywords
- Psychosocial intervention, Surveys, Iron deficiency anemia, Hemoglobin, Menstrual health, Abnormal uterine bleeding (AUB), Community Health Worker, Community Based Participatory Research (CBPR), Health Education
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency, Metrorrhagia, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareBehavioural
Participant will be given verbal and written information on taking iron.
Informational Series and follow-up supportBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Behavioral: Standard of Care; Behavioral: Informational Series and follow-up support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin levels (group level change)
Blood samples will be obtained to measure hemoglobin levels
Measured: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Secondary outcomes (6)
Hemoglobin (Hgb) values (individual change)
Blood samples will be obtained to measure hemoglobin levels
Measured: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Self-reported hemoglobin levels
Self reported hemoglobin value
Measured: 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)?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Erica Marsh, University of Michigan
- Investigators
- Erica Marsh, MD, MSCI, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832526
- Sponsor's protocol ID
- HUM00270428
- Other IDs
- OT2HL158287
- Acronym
- MARCH
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menstruation and Anemia Research: A Community Health Study
- ClinicalTrials.gov ID
- NCT07832526
- Acronym / sponsor ID
- MARCH / HUM00270428
- Conditions
- Anemia
- Keywords
- Psychosocial intervention, Surveys, Iron deficiency anemia, Hemoglobin, Menstrual health, Abnormal uterine bleeding (AUB), Community Health Worker, Community Based Participatory Research (CBPR)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1-Standard of Care (SOC) | Other | Behavioral: Standard of CareParticipants 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) |
| Group 2-SOC and Education/CHW input | Other | Behavioral: Standard of Care, Behavioral: Informational Series and follow-up supportStandard 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 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareParticipant will be given verbal and written information on taking iron. | Behavioural | Group 1-Standard of Care (SOC), Group 2-SOC and Education/CHW input |
| Informational Series and follow-up supportThe 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. | Behavioural | Group 2-SOC and Education/CHW input |
Primary outcome
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
6 secondary outcomes
Hemoglobin (Hgb) values (individual change)
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Self-reported hemoglobin levels
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Anemia status awareness
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Knowledge of anemia
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Confidence in managing anemia as measured by the Perceived Competence Scale
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Knowledge of Abnormal uterine bleeding (AUB)/menstrual health based on knowledge assessment
Time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erica Marsh, MD, MSCI principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Series and follow-up support in people with Anemia, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten Trzeciak (734-647-0307, kioard@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin levels (group level change) (time frame: Visit 1 (approximately day 1), Visit 7 (approximately day 112)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.