Resolution of Uncertainty through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors
Last registered on October 07, 2017

Pre-Trial

Trial Information
General Information
Title
Resolution of Uncertainty through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors
RCT ID
AEARCTR-0001934
Initial registration date
June 06, 2017
Last updated
October 07, 2017 7:44 AM EDT
Location(s)

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Primary Investigator
Affiliation
University of Illinois at Urbana-Champaign
Other Primary Investigator(s)
PI Affiliation
Mbarara University of Science and Technology
PI Affiliation
University of California, San Francisco
Additional Trial Information
Status
On going
Start date
2017-09-28
End date
2019-04-30
Secondary IDs
ClinicalTrials.gov: NCT03179059
Abstract
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.

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.
External Link(s)
Registration Citation
Citation
Comfort, Alison, Joseph Ngonzi and Rebecca Thornton. 2017. "Resolution of Uncertainty through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors." AEA RCT Registry. October 07. https://www.socialscienceregistry.org/trials/1934/history/22107
Experimental Details
Interventions
Intervention(s)
Intervention Start Date
2017-09-28
Intervention End Date
2018-04-30
Primary Outcomes
Primary Outcomes (end points)
Use of any modern family planning method, perceived pregnancy status or degree of uncertainty about pregnancy status, and receipt of ANC during the follow-up period as well as value of pregnancy test (Willingness to pay).
Primary Outcomes (explanation)
We will construct measures for the following FP-related outcomes: use of any short-acting method and use of long-acting reversible method. For ANC-related outcomes, we will measure any ANC visit, gestational age at first ANC visit, and number of ANC visits. 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-analyses among women who are not using modern family planning at baseline and women who are using modern family planning at baseline.
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Following baseline data collection, around 60% of the sample will be provided with a home pregnancy test to assess how resolving uncertainty about pregnancy status affects beliefs and behaviors. During follow-up survey rounds, a subset of women in the treatment group will also be given free pregnancy tests for future use. At endline, we will also experimentally test willingness to pay for home pregnancy tests.
Experimental Design Details
Not available
Randomization Method
Random number generator done in office by a computer
Randomization Unit
Individual
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
No culster
Sample size: planned number of observations
600 women - not pregnant or uncertain of pregnancy status, at risk of pregnancy, and 100 pregnant women
Sample size (or number of clusters) by treatment arms
180 women, offer free pregnancy test at baseline and at follow up survey.
180 women, offer free pregnancy test at baseline.
240 women, control group. No intervention.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
According to the DHS 2016 in Uganda, 34.1% of people use modern contraceptive in Ankole region (sample weighted). Following the power calculation of two proportion test, the treatment group has to have 47.31% take up of family planning with power set at 0.9. This is the 13.21 percentage points increase from the baseline.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Office for the Protection of Research Subjects
IRB Approval Date
2017-06-05
IRB Approval Number
17418
IRB Name
Human Research Protection Program, Institutional Review Board
IRB Approval Date
2017-02-21
IRB Approval Number
16-21381
IRB Name
Mbarara University of Science and Technology, Research Ethics Comittee
IRB Approval Date
2017-03-15
IRB Approval Number
05/01-17