Resolution of Uncertainty Through Testing

NCT ID: NCT03179059

Last Updated: 2018-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-28

Study Completion Date

2017-12-02

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Tests

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pregnancy tests at baseline & follow-up

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

Group Type EXPERIMENTAL

Pregnancy test at Baseline

Intervention Type 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 test at follow up survey

Intervention Type 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 only at baseline

We offer free pregnancy test service at baseline

Group Type EXPERIMENTAL

Pregnancy test at Baseline

Intervention Type 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.

Do Not Offer Pregnancy Test

Control group. No intervention is implemented.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Mbarara University of Science and Technology

OTHER

Sponsor Role collaborator

Ichuli Consulting Limited

UNKNOWN

Sponsor Role collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ichuli Institute

Kampala, , Uganda

Site Status

Countries

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Uganda

Other Identifiers

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uganda_study

Identifier Type: -

Identifier Source: org_study_id

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