Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 223 for:    test | ( Map: Uganda )

Pregnancy Testing in Northern Uganda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03975933
Recruitment Status : Enrolling by invitation
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
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).

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: Free pregnancy test for the future use Diagnostic Test: Pregnancy test for the future use with randomzied price Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pregnancy Testing in Northern Uganda
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Free pregnancy tests at baseline but not for the future
We offer free pregnancy test service at baseline but the respondents do not have an opportunity to receive or buy a pregnancy test.
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.

Experimental: Free pregnancy tests at baseline and for the future
We offer free pregnancy test service at baseline and a free pregnancy test for future use.
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: Free pregnancy test for the future use
We will provide a free pregnancy test in for the future use.

Experimental: Free pregnancy tests at baseline and future use (random price)
We offer free pregnancy test service at baseline and the respondents have an opportunity to buy a pregnancy test.
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 for the future use with randomzied price
We will provide an opportunity to buy a pregnancy test for the future use with randomized price.

No Intervention: Control Group
Control group. No intervention is implemented.
Experimental: Pregnancy test for the future use
No free pregnancy tests at baseline, but receive a free pregnancy test for the future.
Diagnostic Test: Free pregnancy test for the future use
We will provide a free pregnancy test in for the future use.

Experimental: Pregnancy test for the future with random price
No free pregnancy tests at baseline, but receive an opportunity to buy a pregnancy test for the future (ranodmized price).
Diagnostic Test: Pregnancy test for the future use with randomzied price
We will provide an opportunity to buy a pregnancy test for the future use with randomized price.




Primary Outcome Measures :
  1. Binary measures for the family planning take up [ Time Frame: 1 month after baseline ]
    Use of short-term modern family planning short-acting reversible methods. We will measure take up as binary variables.

  2. Binary measure of purchase of pregnancy test kit by price [ Time Frame: 1 month after baseline ]
    Binary measures for the purchase of pregnancy test kit after baseline. Demand for pregnancy test kit is computed by Take it or leave it (TIOLI) method.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  • Sexually Active

Exclusion Criteria:

  • Currently, pregnant women or women who recently gave birth (within 6 weeks of interview)
  • Already using long-term family planning methods (IUD, implant, sterilization)

End Survey if

  • Women in menopause
  • Women with sterilization
  • Women with husband/partner with sterilization
  • Women with long-term family planning methods (IUD and implant)
  • Women who do not understand what menstrual period is
  • Women who is currently pregnant or who recently gave a birth (within 6 weeks of interview)

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): NCT03975933


Locations
Layout table for location information
Uganda
Ichuli Institute
Kampala, Uganda
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Ichuli Consulting Limited
Investigators
Layout table for investigator information
Principal Investigator: Rebecca Thornton, Ph.D. University of Illinois at Urbana-Champaign

Layout table for additonal information
Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03975933     History of Changes
Other Study ID Numbers: UIUC_PT
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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