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Trial record 16 of 9106 for:    pregnancy

Resolution of Uncertainty Through Testing

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ClinicalTrials.gov Identifier: NCT03179059
Recruitment Status : Active, not recruiting
First Posted : June 7, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
University of California, San Francisco
Mbarara University of Science and Technology
Ichuli Consulting Limited
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

Brief 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.


Condition or disease Intervention/treatment Phase
Pregnancy Tests Diagnostic Test: Pregnancy test at Baseline Diagnostic Test: Pregnancy test at follow up survey Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Resolution of Uncertainty Through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors in Uganda
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Pregnancy tests at baseline & follow-up
We offer free pregnancy test service at baseline and at follow-up survey.
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.

Diagnostic Test: Pregnancy test at follow up survey
We will provide a free pregnancy tests in the follow up survey, they are randomly selected from intervention #1 treatment group.

Experimental: Pregnancy tests only at baseline
We offer free pregnancy test service at baseline
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.

No Intervention: Do Not Offer Pregnancy Test
Control group. No intervention is implemented.



Primary Outcome Measures :
  1. Binary measures for the family planning take up [ Time Frame: At end line survey, half a year after intervention ]
    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


Secondary Outcome Measures :
  1. Binary measure of purchase of pregnancy test kit by price [ Time Frame: At end line survey, half a year after intervention ]
    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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179059


Locations
Uganda
Ichuli Institute
Kampala, Uganda
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
University of California, San Francisco
Mbarara University of Science and Technology
Ichuli Consulting Limited

Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03179059     History of Changes
Other Study ID Numbers: uganda_study
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Illinois at Urbana-Champaign:
Reproductive Health
Family Planning
Randomization Trial
Uganda