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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03179059
Other study ID # uganda_study
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03975933 - Pregnancy Testing in Northern Uganda N/A
Recruiting NCT06391112 - The Effect of Painting-Based Art Intervention on Maternal Anxiety and Fetal Parameters N/A
Terminated NCT02524990 - Simplified Medical Abortion Follow-Up N/A