Resolution of Uncertainty Through Testing

Pregnancy Tests Clinical Trial

Official title:

Resolution of Uncertainty Through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors in Uganda

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03179059
• Other study ID #: uganda_study
• Status: Terminated
• Phase: N/A
• Start date: September 28, 2017
• Est. completion date: December 2, 2017

Study information

• Verified date: November 2018
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Given the high rate of delayed adoption of antenatal care (ANC), and high rates of unintended pregnancy and unsafe abortion in Uganda, research on the period of time before confirmation of pregnancy is critical to understand underlying beliefs that guide behaviors ultimately important for maternal and neonatal health (UDHS, 2011; Hussain, 2013).

Home pregnancy tests - which now cost less than 10 cents each - have the potential to facilitate FP uptake and significantly improve reproductive, maternal and child health outcomes in sub-Saharan Africa, including Uganda. These tests are easy to administer, disposable, inexpensive, and have a low false positive rate. Yet, for women living in rural areas in sub-Saharan countries, these tests are typically unavailable outside of health centers or they are prohibitively expensive.

This study will investigate women's underlying beliefs about pregnancy status and examine how providing access to home-based pregnancy tests - thus facilitating earlier resolution of uncertainty of pregnancy status - influences such beliefs and decisions to take up family planning (FP) or seek appropriate pregnancy services.

The results will inform the design of a larger study in the future.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 600
• Est. completion date: December 2, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18-35

• Live in the catchment area

Exclusion Criteria:

• Currently attending school

End Survey if

• Women in menopause

• Women with sterilization

• Women with husband/partner with sterilization

• Women who do not understand what menstrual period is

Related Conditions & MeSH terms

• Pregnancy Tests

Intervention

Diagnostic Test:
• Pregnancy test at Baseline
Among respondents who are randomly selected to receive a free home pregnancy test service, they will be offered the chance to take the test in the presence of the enumerator. Specifically, this would mean they would be given a cup to collect a sample of urine. The respondent would do so privately, then bring the cup back to the enumerator who would dip the home pregnancy tests and assist with interpreting the result. However, respondents can decline to take the test with the enumerator. Treatment assignment will be stratified by whether respondent use modern family planning at baseline.
• Pregnancy test at follow up survey
We will provide a free pregnancy tests in for the future use, they are randomly selected from intervention #1 treatment group.

Locations

Country	Name	City	State
Uganda	Ichuli Institute	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Ichuli Consulting Limited, Mbarara University of Science and Technology, University of California, San Francisco

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binary measures for the family planning take up	Use of any modern family planning method, use of oral contraceptives, use of injectables, use of short-acting reversible methods, use of long-acting reversible methods. We will measure take up as binary variables. We will also conduct sub-group analyses among women who are not using modern family planning at baseline and among women who are using modern family planning at baseline	At end line survey, half a year after intervention
Secondary	Binary measure of purchase of pregnancy test kit by price	Binary measures for the purchase of pregnancy test kit after baseline. Demand for pregnancy test kit is computed by Becker-DeGroot-Marschak (BDM) or/and Take it or leave it (TIOLI) method. We will also conduct sub-group analyses among women who are not using modern family planning at baseline and among women who are using modern family planning at baseline	At end line survey, half a year after intervention