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Resolution of Uncertainty through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors
Last registered on March 26, 2019

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
March 26, 2019 9:58 AM EDT
Location(s)
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
Withdrawn
Start date
2017-09-28
End date
2018-05-01
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. 2019. "Resolution of Uncertainty through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors." AEA RCT Registry. March 26. https://doi.org/10.1257/rct.1934-10.0
Former Citation
Comfort, Alison, Joseph Ngonzi and Rebecca Thornton. 2019. "Resolution of Uncertainty through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors." AEA RCT Registry. March 26. https://www.socialscienceregistry.org/trials/1934/history/44194
Sponsors & Partners

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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
We will conduct two interventions: 1. First, following baseline data collection, 60% of the sample (360 of the 600 women uncertain of pregnancy status at baseline) will be provided with a home pregnancy test to assess how resolving uncertainty about pregnancy status affects beliefs and behaviors. The sample of women will be stratified by whether they use modern family planning at baseline. The pregnancy test consists of a simple dip-strip pregnancy test (dipped into a receptacle of urine). By randomly allocating access to free home pregnancy tests at baseline, we will be able to compare how access to and experience with home pregnancy tests affects a) beliefs about pregnancy status, b) willingness to pay and value of additional pregnancy tests at follow up survey and endline, and c) use of FP services or ANC services. We hypothesize that access can affect behavior through both experience and acquiring information. We will also conduct sub-analyses among women who are not using modern family planning at baseline as well as women who are using modern family planning at baseline. 2. Second, we will provide a free pregnancy tests to some of the respondents in the follow up survey, randomly selected from those who received intervention #1. In the last round of data collection, we will elicit WTP for pregnancy tests among all women. We will use the price indicated as an outcome measure; we expect women with experience using the product (that is, those randomly assigned the free test at baseline) to be WTP. Women who receive a test for free will be able to test for pregnancy in their home if they experience a period of uncertainty or suspect a pregnancy. Pregnant women will also be eligible to purchase a pregnancy tests to assess their demand for these tests. At endline, we will give money as a token of appreciation for their participation in the study, which they can choose to use towards purchasing the home pregnancy tests. Pregnancy tests will then be offered to women for a randomly assigned price ranging from free to a moderate subsidy. Then we will assess the impact of price on demand for home pregnancy tests.
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, 21.43% of people use modern short-term contraceptive (Injectable and Pills) in Ankole region (sample weighted). Following the power calculation of two proportion test, the treatment group has to have 29.57% take up of family planning with power set at 0.9. This is the 8.14 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
Post-Trial
Post Trial Information
Study Withdrawal

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Intervention
Is the intervention completed?
No
Is data collection complete?
No
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers