ContraceptionNCT01893021
Family Planning Knowledge, Attitudes, and Practices of Postpartum Malawian Women
An observational study of Contraception, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial summary
The purpose of this study is to understand the family planning needs and practices of postpartum Malawian women, with a focus on long-acting reversible contraception (LARC). Hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Contraception
- How many people
- 634 participants
- Where
- 1 siteMalawi
- Study dates
- May 2013to Oct 2014
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Our study population will be a sample of 210 HIV+ and 420 HIV- postpartum Malawian women.
Who may be able to join
- Admission to the postpartum ward at Bwaila Maternity Hospital
- Live birth ≥28 weeks gestational age within past 4 weeks
- Fluent in English or Chichewa
- Age 18-45 years
- Access to a working phone number
- Willingness to be contacted by phone for up to one year postpartum
Who cannot join
- History of female sterilization via tubal ligation or hysterectomy
- Prisoner
- History of mental disability
- Serious illness that would prevent participation in the opinion of the Principal Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family Planning Knowledge, Attitudes, and Practices of HIV+ and HIV- Postpartum Malawian Women
The purpose of this study is to understand the family planning needs and practices of postpartum Malawian women, with a focus on long-acting reversible contraception (LARC).
Hypotheses:
- Postpartum women who are older, who have a history of unintended pregnancy, who do not desire another child within 2 years, and who were counseled about LARC during their pregnancy are more likely to have interest in using LARC.
- Postpartum women who are older are more likely to be aware of LARC methods.
- HIV+ postpartum Malawian women will have similar knowledge about LARC as postpartum Malawian women who are HIV-.
Read the detailed description
This study is a prospective cohort study of 630 postpartum Malawian women. Since our focus is on HIV+ women, HIV+ participants will be recruited in a 1:2 ratio, with a total of 210 HIV+ women and 420 HIV- women. We will recruit in the postpartum ward of Bwaila Maternity Hospital in Lilongwe, Malawi. Participants will complete a baseline survey about demographics, reproductive health history, and family planning knowledge, attitudes, and practices. At 3, 6, and 12 months postpartum, we will complete follow-up phone calls to determine what family planning methods they are using and if they encountered any barriers to receiving LARC if they had been interested in using them.
- Conditions
- Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postpartum Malawian women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about the intrauterine device (IUD) and contraceptive implant
A 14-question test about the IUD and implant will be administered to all study participants upon enrollment.
Measured: Upon enrollment
Secondary outcomes (2)
Proportion of women using intrauterine device (IUD) and contraceptive implant
We will compare the proportions of HIV+ and HIV- women who are using the IUD and implant at 3, 6, and 12 months postpartum.
Measured: 3, 6, and 12 months postpartum
Barriers to receiving intrauterine device (IUD) and contraceptive implant
Descriptive statistics will be used to analyze the reasons given for not receiving the IUD or implant at 3, 5, and 12 months postpartum if a woman had wanted to use it.
Measured: Up to 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 North Carolina, Chapel HillThe 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
- Prospective
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Jennifer Tang, MD, MSCR, University of North Carolina, Chapel Hill
- Investigators
- Jennifer Tang, MD, MSCR, Principal investigator, University of North Carolina, Chapel HillMina Hosseinipour, MD, MPH, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893021
- Sponsor's protocol ID
- 13-1084
- Other IDs
- 1R25TW009340-01, P30AI050410
- Status last verified
- Feb 2015
- First submitted
- 26 Jun 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tang JH, Kopp DM, Stuart GS, O'Shea M, Stanley CC, Hosseinipour MC, Miller WC, Mwale M, Kaliti S, Bonongwe P, Rosenberg NE. Association between contraceptive implant knowledge and intent with implant uptake among postpartum Malawian women: a prospective cohort study. Contracept Reprod Med. 2016 Aug 10;1:13. doi: 10.1186/s40834-016-0026-1. eCollection 2016.
PubMed 29201402
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Planning Knowledge, Attitudes, and Practices of HIV+ and HIV- Postpartum Malawian Women
- ClinicalTrials.gov ID
- NCT01893021
- Acronym / sponsor ID
- 13-1084
- Conditions
- Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Jul 2013 (estimated)
- 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 study is to understand the family planning needs and practices of postpartum Malawian women, with a focus on long-acting reversible contraception (LARC).
Hypotheses:
- Postpartum women who are older, who have a history of unintended pregnancy, who do not desire another child within 2 years, and who were counseled about LARC during their pregnancy are more likely to have interest in using LARC.
- Postpartum women who are older are more likely to be aware of LARC methods.
- HIV+ postpartum Malawian women will have similar knowledge about LARC as postpartum Malawian women who are HIV-.
Detailed description
This study is a prospective cohort study of 630 postpartum Malawian women. Since our focus is on HIV+ women, HIV+ participants will be recruited in a 1:2 ratio, with a total of 210 HIV+ women and 420 HIV- women. We will recruit in the postpartum ward of Bwaila Maternity Hospital in Lilongwe, Malawi. Participants will complete a baseline survey about demographics, reproductive health history, and family planning knowledge, attitudes, and practices. At 3, 6, and 12 months postpartum, we will complete follow-up phone calls to determine what family planning methods they are using and if they encountered any barriers to receiving LARC if they had been interested in using them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum Malawian women | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Our study population will be a sample of 210 HIV+ and 420 HIV- postpartum Malawian women.
Key inclusion criteria (6 listed)
- Admission to the postpartum ward at Bwaila Maternity Hospital
- Live birth ≥28 weeks gestational age within past 4 weeks
- Fluent in English or Chichewa
- Age 18-45 years
- Access to a working phone number
Key exclusion criteria (4 listed)
- History of female sterilization via tubal ligation or hysterectomy
- Prisoner
- History of mental disability
- Serious illness that would prevent participation in the opinion of the Principal Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knowledge about the intrauterine device (IUD) and contraceptive implant
Time frame: Upon enrollment
A 14-question test about the IUD and implant will be administered to all study participants upon enrollment.
2 secondary outcomes
Proportion of women using intrauterine device (IUD) and contraceptive implant
Time frame: 3, 6, and 12 months postpartum
Barriers to receiving intrauterine device (IUD) and contraceptive implant
Time frame: Up to 12 months postpartum
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 4 Feb 2015.
- Derived from this study: PubMed 29201402Tang JH, Kopp DM, Stuart GS, O'Shea M, Stanley CC, Hosseinipour MC, Miller WC, Mwale M, Kaliti S, Bonongwe P, Rosenberg NE. Association between contraceptive implant knowledge and intent with implant uptake among postpartum Malawian women: a prospective cohort study. Contracept Reprod Med. 2016 Aug 10;1:13. doi: 10.1186/s40834-016-0026-1. eCollection 2016.
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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.
Jennifer Tang, MD, MSCR principal investigator
University of North Carolina, Chapel Hill
Mina Hosseinipour, MD, MPH study director
University of North Carolina, Chapel Hill
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, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
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 6 inclusion and 4 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 4 Feb 2015. 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 Malawi. 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?
Knowledge about the intrauterine device (IUD) and contraceptive implant (time frame: Upon enrollment). 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 NCT01893021, which also lists 1 linked publication.
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 4 Feb 2015.