Family Planning Knowledge, Attitudes, and Practices of Postpartum Malawian Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Jennifer Tang, MD, MSCR, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01893021
First received: June 26, 2013
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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. 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.
  2. Postpartum women who are older are more likely to be aware of LARC methods.
  3. HIV+ postpartum Malawian women will have similar knowledge about LARC as postpartum Malawian women who are HIV-.

Condition
Contraception

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Family Planning Knowledge, Attitudes, and Practices of HIV+ and HIV- Postpartum Malawian Women

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Knowledge about the intrauterine device (IUD) and contraceptive implant [ Time Frame: Upon enrollment ] [ Designated as safety issue: No ]
    A 14-question test about the IUD and implant will be administered to all study participants upon enrollment.


Secondary Outcome Measures:
  • Proportion of women using intrauterine device (IUD) and contraceptive implant [ Time Frame: 3, 6, and 12 months postpartum ] [ Designated as safety issue: No ]
    We will compare the proportions of HIV+ and HIV- women who are using the IUD and implant at 3, 6, and 12 months postpartum.

  • Barriers to receiving intrauterine device (IUD) and contraceptive implant [ Time Frame: Up to 12 months postpartum ] [ Designated as safety issue: No ]
    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.


Enrollment: 634
Study Start Date: May 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Postpartum Malawian women

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Our study population will be a sample of 210 HIV+ and 420 HIV- postpartum Malawian women.

Criteria

Inclusion Criteria:

  1. Admission to the postpartum ward at Bwaila Maternity Hospital
  2. Live birth ≥28 weeks gestational age within past 4 weeks
  3. Fluent in English or Chichewa
  4. Age 18-45 years
  5. Access to a working phone number
  6. Willingness to be contacted by phone for up to one year postpartum

Exclusion Criteria:

  1. History of female sterilization via tubal ligation or hysterectomy
  2. Prisoner
  3. History of mental disability
  4. Serious illness that would prevent participation in the opinion of the Principal Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893021

Locations
Malawi
Bwaila Maternity Hospital
Lilongwe, Malawi
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Jennifer Tang, MD, MSCR University of North Carolina, Chapel Hill
Study Director: Mina Hosseinipour, MD, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Jennifer Tang, MD, MSCR, Research Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01893021     History of Changes
Other Study ID Numbers: 13-1084, 1R25TW009340-01, P30AI050410
Study First Received: June 26, 2013
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

ClinicalTrials.gov processed this record on October 22, 2014