Back to History

Fields Changed

Trial
Field Before After
Trial Title Resolution of Uncertainty through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors Pregnancy Testing in Northern Uganda
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). The results will inform the design of a larger study in the future. 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.
Trial Start Date August 22, 2018 June 1, 2019
Trial End Date December 31, 2018 December 31, 2019
Last Published August 02, 2018 01:34 AM March 28, 2019 12:45 PM
Intervention Start Date August 22, 2018 June 15, 2019
Intervention End Date December 31, 2018 September 15, 2019
Randomization Method Random number generator done in office by a computer Random number generator in the tablet.
Planned Number of Observations 1200 women - not pregnant or uncertain of pregnancy status, at risk of pregnancy. 1000 women - not pregnant or uncertain of pregnancy status, at risk of pregnancy.
Sample size (or number of clusters) by treatment arms 360 women, offer free pregnancy test at baseline and to keep for the future. 360 women, offer free pregnancy test at baseline. 480 women, control group. No intervention. 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).
Power calculation: Minimum Detectable Effect Size for Main Outcomes 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. 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.
Intervention (Hidden) i. RandomizationA: Randomly provide 60% of the women a home pregnancy test to take at the time of the baseline survey to assess how resolving uncertainty about pregnancy status affects beliefs and behaviors; ii. Randomization B: randomize a subset of the respondents in the treatment group to receive a free pregnancy test i. Randomization A: Randomly provide 40% of the women a home pregnancy test to take at the time of the baseline survey to assess how resolving uncertainty about pregnancy status affects beliefs and behaviors ii. Randomization B: randomize a subset of the respondents in the treatment group and the control group to receive a pregnancy test to be used in the future for free or at some price
Back to top
Irbs
Field Before After

IRB Name

Gulu University Research Ethics Committee

IRB Approval Date

November 6, 2018

IRB Approval Number

GUREC-090-18
Back to top
Field Before After

IRB Name

University of Illinois at Urbana-Champaign Institutional Review Board

IRB Approval Date

March 22, 2019

IRB Approval Number

19138
Back to top
Other Primary Investigators
Field Before After

Affiliation

Harvard T.H.Chan School of Public Health
Back to top
Field Before After
Back to top

Fields Removed

Irbs
Field Value
IRB Name
IRB Approval Date June 5, 2017
IRB Approval Number 17418
Back to top