Pregnancy TestsNCT03179059
Resolution of Uncertainty Through Testing
A study testing Pregnancy test at Baseline and Pregnancy test at follow up survey in people with Pregnancy Tests, run by University of Illinois at Urbana-Champaign at 1 site in Uganda.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Tests
- What is being tested?
- Pregnancy test at Baseline and Pregnancy test at follow up survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUganda
- Study dates
- 28 Sep 2017to 2 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-35
- Live in the catchment area
Who cannot join
- Currently attending school
- End Survey if
- Women in menopause
- Women with sterilization
- Women with husband/partner with sterilization
- Women who do not understand what menstrual period is
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resolution of Uncertainty Through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors in Uganda
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.
Read more
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.
- Conditions
- Pregnancy Tests
- Being tested
- Pregnancy test at Baseline, Pregnancy test at follow up survey
- Keywords
- Reproductive Health, Family Planning, Randomization Trial, Uganda
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnancy test at BaselineDiagnostic test
Among respondents who are randomly selected to receive a free home pregnancy test service, they will be offered the chance to take the test in the presence of the enumerator. Specifically, this would mean they would be given a cup to collect a sample of urine. The respondent would do so privately, then bring the cup back to the enumerator who would dip the home pregnancy tests and assist with interpreting the result. However, respondents can decline to take the test with the enumerator. Treatment assignment will be stratified by whether respondent use modern family planning at baseline.
Pregnancy test at follow up surveyDiagnostic test
We will provide a free pregnancy tests in for the future use, they are randomly selected from intervention #1 treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy tests at baseline & follow-up | Experimental | We offer free pregnancy test service at baseline and at follow-up survey. Receives: Diagnostic Test: Pregnancy test at Baseline; Diagnostic Test: Pregnancy test at follow up survey |
| Pregnancy tests only at baseline | Experimental | We offer free pregnancy test service at baseline Receives: Diagnostic Test: Pregnancy test at Baseline |
| Do Not Offer Pregnancy Test | No intervention | Control group. No intervention is implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary measures for the family planning take up
Use of any modern family planning method, use of oral contraceptives, use of injectables, use of short-acting reversible methods, use of long-acting reversible methods. We will measure take up as binary variables. We will also conduct sub-group analyses among women who are not using modern family planning at baseline and among women who are using modern family planning at baseline
Measured: At end line survey, half a year after intervention
Secondary outcomes (1)
Binary measure of purchase of pregnancy test kit by price
Binary measures for the purchase of pregnancy test kit after baseline. 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-group analyses among women who are not using modern family planning at baseline and among women who are using modern family planning at baseline
Measured: At end line survey, half a year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start28 Sep 2017
- Primary completion1 Dec 2017
- Study completion2 Dec 2017
Why it stopped: Difficulties in field coordination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Mbarara University of Science and Technology, Ichuli Consulting Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179059
- Sponsor's protocol ID
- uganda_study
- Status last verified
- Nov 2018
- First submitted
- 24 May 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolution of Uncertainty Through Testing: The Impact of Pregnancy Tests on Reproductive and Maternal Health Beliefs and Behaviors in Uganda
- ClinicalTrials.gov ID
- NCT03179059
- Acronym / sponsor ID
- uganda_study
- Conditions
- Pregnancy Tests
- Keywords
- Reproductive Health, Family Planning, Randomization Trial, Uganda
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in field coordination
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Mbarara University of Science and Technology, Ichuli Consulting Limited
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 2 Dec 2017 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) or seek appropriate pregnancy services.
The results will inform the design of a larger study in the future.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnancy tests at baseline & follow-up | Experimental | Diagnostic Test: Pregnancy test at Baseline, Diagnostic Test: Pregnancy test at follow up surveyWe offer free pregnancy test service at baseline and at follow-up survey. |
| Pregnancy tests only at baseline | Experimental | Diagnostic Test: Pregnancy test at BaselineWe offer free pregnancy test service at baseline |
| Do Not Offer Pregnancy Test | No intervention | –Control group. No intervention is implemented. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the ages of 18-35
- Live in the catchment area
Key exclusion criteria (6 listed)
- Currently attending school
- End Survey if
- Women in menopause
- Women with sterilization
- Women with husband/partner with sterilization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnancy test at BaselineAmong respondents who are randomly selected to receive a free home pregnancy test service, they will be offered the chance to take the test in the presence of the enumerator. Specifically, this would mean they would be given a cup to collect a sample of urine. The respondent would do so privately, then bring the cup back to the enumerator who would dip the home pregnancy tests and assist with interpreting the result. However, respondents can decline to take the test with the enumerator. Treatment assignment will be stratified by whether respondent use modern family planning at baseline. | Diagnostic test | Pregnancy tests at baseline & follow-up, Pregnancy tests only at baseline |
| Pregnancy test at follow up surveyWe will provide a free pregnancy tests in for the future use, they are randomly selected from intervention #1 treatment group. | Diagnostic test | Pregnancy tests at baseline & follow-up |
Primary outcome
Binary measures for the family planning take up
Time frame: At end line survey, half a year after intervention
Use of any modern family planning method, use of oral contraceptives, use of injectables, use of short-acting reversible methods, use of long-acting reversible methods. We will measure take up as binary variables. We will also conduct sub-group analyses among women who are not using modern family planning at baseline and among women who are using modern family planning at baseline
1 secondary outcome
Binary measure of purchase of pregnancy test kit by price
Time frame: At end line survey, half a year after intervention
Results and safety
The study was stopped early (reason given: Difficulties in field coordination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Tests
Active, not recruiting
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Neonatal Abstinence Syndrome, Opioid-use Disorder
Active, not recruiting
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)
Cervical Carcinoma, Human Papillomavirus Infection
Enrolling by invitationObservational study
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Acute Kidney Injury
Active, not recruiting
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)
Cervical Carcinoma, Human Papillomavirus Infection
Not yet recruiting
C2001P-CS3: Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV
Human Papillomavirus (HPV), HPV Associated Cancers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregnancy test at Baseline and Pregnancy test at follow up survey in people with Pregnancy Tests, run by University of Illinois at Urbana-Champaign at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties in field coordination). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binary measures for the family planning take up (time frame: At end line survey, half a year after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.