Resolution of Uncertainty Through Testing

NCT03179059 | Terminated

• 1 other identifier: uganda_study
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Tests

Keywords

Reproductive Health; Family Planning; Randomization Trial; Uganda

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Binary measure of purchase of pregnancy test kit by price

  At end line survey, half a year after intervention

Study Arms (3)

Pregnancy tests at baseline & follow-up

EXPERIMENTAL

We offer free pregnancy test service at baseline and at follow-up survey.

Diagnostic Test: Pregnancy test at Baseline; Diagnostic Test: Pregnancy test at follow up survey

Pregnancy tests only at baseline

EXPERIMENTAL

We offer free pregnancy test service at baseline

Diagnostic Test: Pregnancy test at Baseline

Do Not Offer Pregnancy Test

NO INTERVENTION

Control group. No intervention is implemented.

Interventions

Pregnancy test at Baseline DIAGNOSTIC_TEST

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 tests at baseline & follow-up; Pregnancy tests only at baseline

Pregnancy test at follow up survey DIAGNOSTIC_TEST

We will provide a free pregnancy tests in for the future use, they are randomly selected from intervention #1 treatment group.

Pregnancy tests at baseline & follow-up

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18-35
• Live in the catchment area

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• University of California, San Francisco: collaborator
• Mbarara University of Science and Technology: collaborator
• Ichuli Consulting Limited: collaborator

Study Sites (1)

Ichuli Institute

Kampala, Uganda

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 7, 2017
• Study Start: September 28, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 2, 2017
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)