Clinical trial NCT01893021: Family Planning Knowledge, Attitudes, and Practices of Postpartum Malawian Women
Official title: Family Planning Knowledge, Attitudes, and Practices of HIV+ and HIV- Postpartum Malawian Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2013-07-08
Enrollment: 634
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Our study population will be a sample of 210 HIV+ and 420 HIV- postpartum Malawian women.

Brief 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-.

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 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

Primary outcomes:
measure: Knowledge about the intrauterine device (IUD) and contraceptive implant
timeFrame: Upon enrollment
Secondary outcomes:
measure: Proportion of women using intrauterine device (IUD) and contraceptive implant
timeFrame: 3, 6, and 12 months postpartum
measure: Barriers to receiving intrauterine device (IUD) and contraceptive implant
timeFrame: Up to 12 months postpartum
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Bwaila Maternity Hospital
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jennifer Tang, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Mina Hosseinipour, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.