Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03975933 |
| Other study ID # |
UIUC_PT |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 14, 2019 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
January 2019 |
| Source |
University of Illinois at Urbana-Champaign |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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).
The results will inform the design of a larger study in the future.
Description:
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).
Unmet demand for contraceptives remains high in sub-Saharan Africa, with 25% of married women
reporting wanting to avoid pregnancy but not currently using modern contraceptives (Clifton
and Kaneda, 2013). One factor contributing to unmet demand is that women are refused access
to hormonal contraceptives in some settings, because FP providers cannot rule out pregnancy
if the woman is not menstruating at the time of her visit (Campbell et al., 2006; Shelton et
al., 1992; Stanback et al., 1997). While the current standard is for health providers to use
a simple six-question checklist to rule out pregnancy, the checklist has a false positive
rate ranging from 11% to 64% (Tepper et al. 2013) and health workers often end up not
trusting it (Comfort et al., 2016; Hoke et al., 2012). Pregnancy tests can give
non-menstruating women the ability to confirm they are not pregnant and access hormonal
contraceptive methods when they may otherwise be denied (Stanback et al., 2013). Greater
access to pregnancy tests may also motivate women who are uncertain about their pregnancy
status to adopt FP methods if they receive a negative test result and do not wish to have
additional children. The administration of a home pregnancy test by a FP provider, including
community health workers, can also serve as an opportunity for FP counseling which may
further increase uptake.
Confirmation of negative pregnancy status can also reduce psychological anxiety, especially
for women who may wish to delay or avoid becoming pregnant. Among women who may be using
different forms of contraceptives, confirmation of negative pregnancy could provide proof of
the methods' effectiveness thereby encouraging these women to continue use. Almost half of
women in Uganda who adopt a contraceptive method discontinue use within 12 months and about
13% discontinue use of short-acting hormonal contraceptives because of method failure ((UBOS)
and International 2012). Especially among women using these particular methods, confirming
their negative pregnancy status could encourage them to continue use. For women with partners
who want to delay or avoid pregnancy, confirming negative pregnancy status could reduce
domestic violence and reduce marital distress. In Uganda, almost 60% of women have
experienced physical violence in their lifetime, and 60% of these women report that
perpetrator was their current spouse ((UBOS) and International 2012). In addition, among
Ugandan women who have ever been pregnant, 16% report having experienced physical violence
during pregnancy; the likelihood of violence during pregnancy is higher for women who have
five or more children, lower education, or lower income ((UBOS) and International 2012).
Confirmation of negative pregnancy could also aid with household decision-making and
planning; for example, women who confirm they are not pregnant could make greater investment
(financial, time, physical) in their children.
Although coverage for at least one ANC visit is high in most developing countries, this is
not predictive of coverage for at least four visits - the previous number of recommended
visit by the World Health Organization (AbouZahr and Wardlaw, 2001) and is far from reaching
the most recent WHO recommendation of at least 8 visits during a pregnancy (WHO 2016).
According to the 2011 Uganda Demographic and Health Survey, 95% of women receive ANC from a
skilled provider. However, only 48% attend four or more visits, and the median gestational
age at the first visit is 5.1 months - well into the second trimester - even though the WHO
recommends initiating ANC as early as possible (UDHS, 2011). There is some existing evidence
suggesting that women wait to seek ANC because of uncertainty about their pregnancy status
(Myer and Harrison, 2003).
In addition, earlier recognition of a pregnancy could allow women to plan for unwanted
pregnancies. For pregnancies that are carried to term, earlier recognition would allow women
to adopt healthy prenatal behaviors earlier (such as avoiding alcohol consumption and
smoking, taking prenatal vitamins, and using antimalarial bednets). Women would be better
able to plan for the delivery, including saving for delivery-related costs, such as
transportation, provider fees, and facility fees and planning for the location of the
delivery and attendance at delivery. It would also allow women to adopt effective malaria
prevention behaviors; while the WHO recommends that pregnant women receive intermittent
preventive treatment for malaria as soon as possible in the 2nd trimester, pregnant women
should be using anti-malarial bednets during the 1st trimester (when iPTP is
contra-indicated) to protect against malaria infection, which can result in maternal and
fetal anemia, placental parasitaemia, low birth weight, and neonatal mortality (WHO 2012).
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.
This protocol outlines our proposed study. The results will inform the design of a larger
study.
a. Objectives
The main objectives of this study are to understand the impact of increasing women's access
to home pregnancy tests on reproductive health care seeking. In this study we focus on
non-pregnant women and subsequent effects of access to pregnancy tests. Specifically, the
main research questions of the proposed study are:
1. Beliefs: How do women form their beliefs about their pregnancy status, risk of pregnancy
and how do these beliefs correlate with behaviors related to contraceptive adoption
among non-pregnant women?
2. Effects of access to pregnancy tests: What are the effects of resolving uncertainty
through home pregnancy tests on beliefs and reproductive behaviors including FP uptake,
psychological well-being, and contraceptive continuation)?
3. Demand/Value of pregnancy tests: What is take-up of free pregnancy tests and if the test
is distributed for free, at what point in time in the month (in relationship to their
menstrual cycle or sexual behavior) do women most value using it if they are distributed
for free? Does willingness to pay for these tests vary by prior experience with
pregnancy tests and key characteristics such as age and number of previous pregnancies?
We hypothesize that providing access to pregnancy tests could influence reproductive
behaviors in the following ways:
Hypothesis 1: For women who test negative, confirmation of negative pregnancy status using
home pregnancy tests will facilitate adoption of modern contraceptives to prevent unintended
pregnancies and reduce anxiety.
Hypothesis 2: Women who are most uncertain of their pregnancy status (correlated with beliefs
and sexual behavior) will have a higher value of the pregnancy test (more willing to adopt or
higher willingness to pay).
