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

Contraception Clinical Trial

Official title:

Family Planning Knowledge, Attitudes, and Practices of HIV+ and HIV- Postpartum Malawian Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893021
• Other study ID #: 13-1084
• Secondary ID: 1R25TW009340-01P
• Status: Completed
• Phase: N/A
• First received: June 26, 2013
• Last updated: February 3, 2015
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical 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. 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-.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contraception

Locations

Country	Name	City	State
Malawi	Bwaila Maternity Hospital	Lilongwe

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	John E. Fogarty International Center (FIC), National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Upon enrollment	No
Secondary	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.	3, 6, and 12 months postpartum	No
Secondary	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.	Up to 12 months postpartum	No