Pregnancy Testing in Northern Uganda
Last registered on December 20, 2019

Pre-Trial

Trial Information
General Information
Title
Pregnancy Testing in Northern Uganda
RCT ID
AEARCTR-0003187
Initial registration date
July 29, 2018
Last updated
December 20, 2019 3:00 PM EST
Location(s)
Primary Investigator
Affiliation
University of Illinois, Urbana-Champaign
Other Primary Investigator(s)
PI Affiliation
Harvard T.H.Chan School of Public Health
PI Affiliation
University of Illinois at Urbana-Champaign
Additional Trial Information
Status
On going
Start date
2019-05-14
End date
2020-03-15
Secondary IDs
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 the 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.
External Link(s)
Registration Citation
Citation
Kamei, Akito, Ryoko Sato and Rebecca Thornton. 2019. "Pregnancy Testing in Northern Uganda." AEA RCT Registry. December 20. https://doi.org/10.1257/rct.3187-4.1.
Former Citation
Kamei, Akito et al. 2019. "Pregnancy Testing in Northern Uganda." AEA RCT Registry. December 20. http://www.socialscienceregistry.org/trials/3187/history/59451.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
Intervention Start Date
2019-05-14
Intervention End Date
2019-09-10
Primary Outcomes
Primary Outcomes (end points)
Use of any modern family planning method, perceived pregnancy status or degree of uncertainty about pregnancy status, and the 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. Demand for pregnancy test kit is computed by 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.
Experimental Design Details
1. First, following baseline data collection, approximately 40% of the sample (400 of the 1000 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 pregnancy test consists of a simple dip-strip pregnancy test (dipped into a receptacle of urine) and an informational pamphlet explaining how and when to use the test and interpret the results. 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 baseline and endline, and c) use of FP services or ANC services. We hypothesize that access can affect behavior through both experience and acquiring information. 2. Second, we will randomly select some women both in the treatment group and in the control group to receive a home pregnancy test at the end of the baseline for use in the future either for free (about 50 women in each group; treatment and control group) or at some price (about 150 women in each group will be randomly offered a pregnancy test at some price). Women who receive a test at the end of endline will be able to test for pregnancy in their home if they experience a period of uncertainty or suspect a pregnancy. 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 to elicit willingness to pay for pregnancy tests. We will use the price indicated as an outcome measure. Follow-up data collection will occur approximately one month after baseline to measure instances of suspected pregnancy, reproductive behavior, sexual activity, signs of pregnancy, family planning use and beliefs, and maternal health care-seeking.
Randomization Method
Random number generator in the tablet.
Randomization Unit
Individual
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
No culster
Sample size: planned number of observations
1000 women - not pregnant or uncertain of pregnancy status, at risk of pregnancy.
Sample size (or number of clusters) by treatment arms
200 women, offer free pregnancy test at baseline
50 women, offer free pregnancy test at baseline and to keep for the future (free).
150 women, offer free pregnancy test at baseline and to keep for the future (with randomized price).
400 women, control group. No intervention.
50 women, offer free pregnancy test for the future.
150 women, offer pregnancy test to keep for the future (with randomized price).
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.Our target sample size is 1,000 women. With 1,000 subjects, we can test various hypothesis as outlined below. Primarily, we compare 400 women who will be offered the pregnancy test under the treatment group and another 400 women in the control group who will not be offered the pregnancy test. The main outcome is the take-up of the modern family planning methods. This sample size of 800 women allows us to detect the standardized effect size 0.2 with power 0.8 and significance level 0.05. Assuming conservatively that the standard error is 0.5, we expect the treatment effect is 10 percentage points increase in the family planning take-up. We will additionally test if the previous experience of pregnancy test affects the willingness to pay for the pregnancy test, among 400 women (200 in treatment and 200 in control). This sample size allows us to detect the standardized effect size 0.28. Although this is a pilot study to test out the hypothesis using the small sample, we plan to scale-up in the future using the sufficient sample size, should we see any potential effect through this pilot study.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
University of Illinois at Urbana-Champaign Institutional Review Board
IRB Approval Date
2019-03-22
IRB Approval Number
19138
IRB Name
Gulu University Research Ethics Committee
IRB Approval Date
2018-11-06
IRB Approval Number
GUREC-090-18
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers