ContraceptionNCT03153644
Helping People With Health Conditions Make Birth Control Decisions
An observational study of Contraception and Chronic Disease, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this project is to describe how contraceptive services are currently being delivered to women with medical conditions who seek care in community-based primary care settings, such as family medicine and internal medicine clinical offices. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Chronic Disease
- What is being tested?
- Interview and Observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2017to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Identification of primary care practices (5-10) that provide primary care services and provide prescriptions for birth control and/or provide insertion/removal of contraceptive devices (the intrauterine device or sub-dermal implant) within southeast Michigan. Primary care physicians (30) and medical staff (30) within the primary care practices identified for recruitment will be approached for interviews. Approximately 30 women will be approached about participation in the study after the approval of the primary care physician. A convenience sampling approach will be used.
Who may be able to join
None listed.
Who cannot join
- Patients who meet any of the following criteria will be excluded:
- surgically or medically sterile or whose current male partner(s) are surgically or medically sterile
- females under 18 years are excluded because prior literature has shown that their healthcare and pregnancy-related experiences differ substantially enough from those of adult women.
- Practice Members Inclusion Criteria:
- To be eligible for the study, the practice member must meet all the following criteria:
- Age 18 or older
Show all 13Show fewer
- Able to speak English
- Able to give informed consent
- Indirectly or directly involved with patient care
- Primary Practices:
- To be eligible for the study, primary care practices must meet all the following criteria:
- currently provide primary care services to reproductive-aged women aged 18-45
- currently provide prescriptions for birth control and/or provide insertion/removal of contraceptive devices (the intrauterine device or sub-dermal implant) on site OR refer patients to another site.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Family Medicine
Ann Arbor, Michigan, 48104
About this study
Official title: Improving Contraceptive Care for Individuals With Chronic Conditions
The purpose of this project is to describe how contraceptive services are currently being delivered to women with medical conditions who seek care in community-based primary care settings, such as family medicine and internal medicine clinical offices.
Read the detailed description
This pilot study seeks to:
- To understand women's beliefs, attitudes, and experiences with contraception in context of their medical conditions, drug therapy, personal preferences, and current experiences in primary care.
- To describe provider- To describe provider- and practice-level factors that impact the delivery of contraceptive services in primary care.
To seek the perspectives of multiple stakeholders: 1) women aged 18-50 with one or more medical conditions; and 2) practice members who consist of primary care providers (PCPs) and office staff (e.g. nurses, medical assistants, and administrative staff members). The specific objective of this formative, qualitative study is to identify key patient-, provider-, and practice-level factors that are critical to the delivery of contraceptive counseling and services to women with medical conditions.
To accomplish these aims, qualitative data will be collected in clinical settings that currently provide primary care and family planning for reproductive-aged women with medical conditions. Data collected will be: 1) in-depth interviews with women with medical conditions and practice members; and 2) semi-structured observations of office activities and processes (e.g. patient check in, patient scheduling).
Using rigorous qualitative mixed methods to collect and analyze data, a deeper understanding will be gained of factors that should be considered in the design and implementation of future interventions to improve contraceptive care for women with medical conditions in primary care.
- Conditions
- Contraception, Chronic Disease
- Being tested
- Interview, Observation
- Keywords
- Qualitative Research, Medical conditions, Birth control methods, Intrauterine Devices, Physicians, Primary Care, Long-acting reversible contraceptives (LARC)
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
1 hour semi-structured
ObservationBehavioural
Field Observation
| Study group | Role | What they receive |
|---|---|---|
| Patients | Women with chronic medical conditions Receives: Behavioral: Interview | |
| Primary Care Providers and Medical Staff | Primary care providers can include doctors and advanced practice professionals, including midwives, nurse practitioners, and physician assistants.
Medical staff can include social workers, nurses, medical assistants, and administrative staff Receives: Behavioral: Interview | |
| Primary Practice | Primary care practices (family medicine, internal medicine, medicine-pediatric, or any combination of these) that at a practice-level already provide contraceptive counseling and services to reproductive-age women Receives: Behavioral: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors To Guide the Design of Contraceptive Design Application
A semi-structured interview will be used to identify patient-, provider- and practice-level factors that are relevant to the design and implementation of a contraceptive decision aid.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start7 Sep 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Justine Wu, University of Michigan
- Investigators
- Justine P WU, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153644
- Sponsor's protocol ID
- HUM0012060
- Other IDs
- 1K23HD084744-01A1
- Status last verified
- Jul 2025
- First submitted
- 12 May 2017
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Final sets of data may be shared for use via a signed Data Sharing Agreement. 1. The organizations in the project remain the full/joint owners of such data. 2. One of the following two conditions must be met: a. No personal health identifiers are included in the final data set; b. Appropriate patient consent and institutional review board waiver has been obtained for all identifiable data 3. All data transferred will be in an encrypted format and stored securely. 4. Both parties agree not to release information about specific identifiable subjects to anyone. 5. Both parties agree to the boundary conditions of the original proposal under which data sharing was initiated. 6. Both parties agree to support of the pertinent grant awards as part of published acknowledgments section for any document shared under this agreement. 7. All publications arising from this shared data set must be reviewed and approved by Principle Investigator of the study.
Publications
Chor J, Rankin K, Harwood B, Handler A. Unintended pregnancy and postpartum contraceptive use in women with and without chronic medical disease who experienced a live birth. Contraception. 2011 Jul;84(1):57-63. doi: 10.1016/j.contraception.2010.11.018. Epub 2011 Jan 20.
PubMed 21664511DeNoble AE, Hall KS, Xu X, Zochowski MK, Piehl K, Dalton VK. Receipt of prescription contraception by commercially insured women with chronic medical conditions. Obstet Gynecol. 2014 Jun;123(6):1213-1220. doi: 10.1097/AOG.0000000000000279.
PubMed 24807345Ornstein SM, Nietert PJ, Jenkins RG, Litvin CB. The prevalence of chronic diseases and multimorbidity in primary care practice: a PPRNet report. J Am Board Fam Med. 2013 Sep-Oct;26(5):518-24. doi: 10.3122/jabfm.2013.05.130012.
PubMed 24004703Akers AY, Gold MA, Borrero S, Santucci A, Schwarz EB. Providers' perspectives on challenges to contraceptive counseling in primary care settings. J Womens Health (Larchmt). 2010 Jun;19(6):1163-70. doi: 10.1089/jwh.2009.1735.
PubMed 20420508Dehlendorf C, Levy K, Ruskin R, Steinauer J. Health care providers' knowledge about contraceptive evidence: a barrier to quality family planning care? Contraception. 2010 Apr;81(4):292-8. doi: 10.1016/j.contraception.2009.11.006. Epub 2009 Dec 11.
PubMed 20227544Curtis KM, Tepper NK, Jamieson DJ, Marchbanks PA. Adaptation of the World Health Organization's Selected Practice Recommendations for Contraceptive Use for the United States. Contraception. 2013 May;87(5):513-6. doi: 10.1016/j.contraception.2012.08.024. Epub 2012 Oct 4.
PubMed 23040134Lee JK, Parisi SM, Akers AY, Borrero S, Schwarz EB. The impact of contraceptive counseling in primary care on contraceptive use. J Gen Intern Med. 2011 Jul;26(7):731-6. doi: 10.1007/s11606-011-1647-3.
PubMed 21301983Dicicco-Bloom B, Crabtree BF. The qualitative research interview. Med Educ. 2006 Apr;40(4):314-21. doi: 10.1111/j.1365-2929.2006.02418.x.
PubMed 16573666Crabtree BF, Miller WL. A qualitative approach to primary care research: the long interview. Fam Med. 1991 Feb;23(2):145-51.
PubMed 2037216Wu JP, Damschroder LJ, Fetters MD, Zikmund-Fisher BJ, Crabtree BF, Hudson SV, Ruffin MT IV, Fucinari J, Kang M, Taichman LS, Creswell JW. A Web-Based Decision Tool to Improve Contraceptive Counseling for Women With Chronic Medical Conditions: Protocol For a Mixed Methods Implementation Study. JMIR Res Protoc. 2018 Apr 18;7(4):e107. doi: 10.2196/resprot.9249.
PubMed 29669707
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Contraceptive Care for Individuals With Chronic Conditions
- ClinicalTrials.gov ID
- NCT03153644
- Acronym / sponsor ID
- HUM0012060
- Conditions
- Contraception, Chronic Disease
- Keywords
- Qualitative Research, Medical conditions, Birth control methods, Intrauterine Devices, Physicians, Primary Care, Long-acting reversible contraceptives (LARC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 15 May 2017 (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.
The purpose of this project is to describe how contraceptive services are currently being delivered to women with medical conditions who seek care in community-based primary care settings, such as family medicine and internal medicine clinical offices.
Detailed description
This pilot study seeks to:
- To understand women's beliefs, attitudes, and experiences with contraception in context of their medical conditions, drug therapy, personal preferences, and current experiences in primary care.
- To describe provider- To describe provider- and practice-level factors that impact the delivery of contraceptive services in primary care.
To seek the perspectives of multiple stakeholders: 1) women aged 18-50 with one or more medical conditions; and 2) practice members who consist of primary care providers (PCPs) and office staff (e.g. nurses, medical assistants, and administrative staff members). The specific objective of this formative, qualitative study is to identify key patient-, provider-, and practice-level factors that are critical to the delivery of contraceptive counseling and services to women with medical conditions.
To accomplish these aims, qualitative data will be collected in clinical settings that currently provide primary care and family planning for reproductive-aged women with medical conditions. Data collected will be: 1) in-depth interviews with women with medical conditions and practice members; and 2) semi-structured observations of office activities and processes (e.g. patient check in, patient scheduling).
Using rigorous qualitative mixed methods to collect and analyze data, a deeper understanding will be gained of factors that should be considered in the design and implementation of future interventions to improve contraceptive care for women with medical conditions in primary care.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: InterviewWomen with chronic medical conditions |
| Primary Care Providers and Medical Staff | – | Behavioral: InterviewPrimary care providers can include doctors and advanced practice professionals, including midwives, nurse practitioners, and physician assistants. Medical staff can include social workers, nurses, medical assistants, and administrative staff |
| Primary Practice | – | Behavioral: ObservationPrimary care practices (family medicine, internal medicine, medicine-pediatric, or any combination of these) that at a practice-level already provide contraceptive counseling and services to reproductive-age women |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Identification of primary care practices (5-10) that provide primary care services and provide prescriptions for birth control and/or provide insertion/removal of contraceptive devices (the intrauterine device or sub-dermal implant) within southeast Michigan. Primary care physicians (30) and medical staff (30) within the primary care practices identified for recruitment will be approached for interviews. Approximately 30 women will be approached about participation in the study after the approval of the primary care physician. A convenience sampling approach will be used.
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- surgically or medically sterile or whose current male partner(s) are surgically or medically sterile
- females under 18 years are excluded because prior literature has shown that their healthcare and pregnancy-related experiences differ substantially enough from those of adult women.
- Age 18 or older
- Able to speak English
- Able to give informed consent
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 |
|---|---|---|
| Interview1 hour semi-structured | Behavioural | Patients, Primary Care Providers and Medical Staff |
| ObservationField Observation | Behavioural | Primary Practice |
Primary outcome
Factors To Guide the Design of Contraceptive Design Application
Time frame: 6 months
A semi-structured interview will be used to identify patient-, provider- and practice-level factors that are relevant to the design and implementation of a contraceptive decision aid.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Background: PubMed 21664511Chor J, Rankin K, Harwood B, Handler A. Unintended pregnancy and postpartum contraceptive use in women with and without chronic medical disease who experienced a live birth. Contraception. 2011 Jul;84(1):57-63. doi: 10.1016/j.contraception.2010.11.018. Epub 2011 Jan 20.
- Background: PubMed 24807345DeNoble AE, Hall KS, Xu X, Zochowski MK, Piehl K, Dalton VK. Receipt of prescription contraception by commercially insured women with chronic medical conditions. Obstet Gynecol. 2014 Jun;123(6):1213-1220. doi: 10.1097/AOG.0000000000000279.
- Background: PubMed 24004703Ornstein SM, Nietert PJ, Jenkins RG, Litvin CB. The prevalence of chronic diseases and multimorbidity in primary care practice: a PPRNet report. J Am Board Fam Med. 2013 Sep-Oct;26(5):518-24. doi: 10.3122/jabfm.2013.05.130012.
- Background: PubMed 20420508Akers AY, Gold MA, Borrero S, Santucci A, Schwarz EB. Providers' perspectives on challenges to contraceptive counseling in primary care settings. J Womens Health (Larchmt). 2010 Jun;19(6):1163-70. doi: 10.1089/jwh.2009.1735.
- Background: PubMed 20227544Dehlendorf C, Levy K, Ruskin R, Steinauer J. Health care providers' knowledge about contraceptive evidence: a barrier to quality family planning care? Contraception. 2010 Apr;81(4):292-8. doi: 10.1016/j.contraception.2009.11.006. Epub 2009 Dec 11.
- Background: PubMed 23040134Curtis KM, Tepper NK, Jamieson DJ, Marchbanks PA. Adaptation of the World Health Organization's Selected Practice Recommendations for Contraceptive Use for the United States. Contraception. 2013 May;87(5):513-6. doi: 10.1016/j.contraception.2012.08.024. Epub 2012 Oct 4.
- Background: PubMed 21301983Lee JK, Parisi SM, Akers AY, Borrero S, Schwarz EB. The impact of contraceptive counseling in primary care on contraceptive use. J Gen Intern Med. 2011 Jul;26(7):731-6. doi: 10.1007/s11606-011-1647-3.
- Background: PubMed 16573666Dicicco-Bloom B, Crabtree BF. The qualitative research interview. Med Educ. 2006 Apr;40(4):314-21. doi: 10.1111/j.1365-2929.2006.02418.x.
- Background: PubMed 2037216Crabtree BF, Miller WL. A qualitative approach to primary care research: the long interview. Fam Med. 1991 Feb;23(2):145-51.
- Derived from this study: PubMed 29669707Wu JP, Damschroder LJ, Fetters MD, Zikmund-Fisher BJ, Crabtree BF, Hudson SV, Ruffin MT IV, Fucinari J, Kang M, Taichman LS, Creswell JW. A Web-Based Decision Tool to Improve Contraceptive Counseling for Women With Chronic Medical Conditions: Protocol For a Mixed Methods Implementation Study. JMIR Res Protoc. 2018 Apr 18;7(4):e107. doi: 10.2196/resprot.9249.
- Individual participant dataSharing planned: Undecided. Final sets of data may be shared for use via a signed Data Sharing Agreement. 1. The organizations in the project remain the full/joint owners of such data. 2. One of the following two conditions must be met: a. No personal health identifiers are included in the final data set; b. Appropriate patient consent and institutional review board waiver has been obtained for all identifiable data 3. All data transferred will be in an encrypted format and stored securely. 4. Both parties agree not to release information about specific identifiable subjects to anyone. 5. Both parties agree to the boundary conditions of the original proposal under which data sharing was initiated. 6. Both parties agree to support of the pertinent grant awards as part of published acknowledgments section for any document shared under this agreement. 7. All publications arising from this shared data set must be reviewed and approved by Principle Investigator of the study.
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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. This study is not recruiting at the moment.
Justine P WU, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Chronic Disease, run by University of Michigan at 1 site 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 0 inclusion and 13 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: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors To Guide the Design of Contraceptive Design Application (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153644, which also lists 10 linked publications.
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 23 Jul 2025.