NCT03975933

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,033

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

May 14, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 13, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

July 30, 2018

Last Update Submit

November 12, 2019

Conditions

Keywords

Reproductive HealthFamily PlanningRandomization TrialUganda

Outcome Measures

Primary Outcomes (2)

  • Binary measures for the family planning take up

    Use of short-term modern family planning short-acting reversible methods. We will measure take up as binary variables.

    1 month after baseline

  • 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 Take it or leave it (TIOLI) method.

    1 month after baseline

Study Arms (6)

Free pregnancy tests at baseline but not for the future

EXPERIMENTAL

We offer free pregnancy test service at baseline but the respondents do not have an opportunity to receive or buy a pregnancy test.

Diagnostic Test: Pregnancy test at Baseline

Free pregnancy tests at baseline and for the future

EXPERIMENTAL

We offer free pregnancy test service at baseline and a free pregnancy test for future use.

Diagnostic Test: Pregnancy test at BaselineDiagnostic Test: Free pregnancy test for the future use

Free pregnancy tests at baseline and future use (random price)

EXPERIMENTAL

We offer free pregnancy test service at baseline and the respondents have an opportunity to buy a pregnancy test.

Diagnostic Test: Pregnancy test at BaselineDiagnostic Test: Pregnancy test for the future use with randomzied price

Control Group

NO INTERVENTION

Control group. No intervention is implemented.

Pregnancy test for the future use

EXPERIMENTAL

No free pregnancy tests at baseline, but receive a free pregnancy test for the future.

Diagnostic Test: Free pregnancy test for the future use

Pregnancy test for the future with random price

EXPERIMENTAL

No free pregnancy tests at baseline, but receive an opportunity to buy a pregnancy test for the future (ranodmized price).

Diagnostic Test: Pregnancy test for the future use with randomzied price

Interventions

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.

Free pregnancy tests at baseline and for the futureFree pregnancy tests at baseline and future use (random price)Free pregnancy tests at baseline but not for the future

We will provide a free pregnancy test in for the future use.

Free pregnancy tests at baseline and for the futurePregnancy test for the future use

We will provide an opportunity to buy a pregnancy test for the future use with randomized price.

Free pregnancy tests at baseline and future use (random price)Pregnancy test for the future with random price

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-35
  • Live in the catchment area
  • Sexually Active

You may not qualify if:

  • Currently, pregnant women or women who recently gave birth (within 6 weeks of interview)
  • Already using long-term family planning methods (IUD, implant, sterilization)
  • End Survey if
  • Women in menopause
  • Women with sterilization
  • Women with husband/partner with sterilization
  • Women with long-term family planning methods (IUD and implant)
  • Women who do not understand what menstrual period is
  • Women who is currently pregnant or who recently gave a birth (within 6 weeks of interview)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ichuli Institute

Kampala, Uganda

Location

Related Publications (2)

  • Kamei A, Sato R, Thornton R. Factors associated with knowledge and use of home pregnancy test kits in Uganda. PLOS Glob Public Health. 2023 Jul 13;3(7):e0002165. doi: 10.1371/journal.pgph.0002165. eCollection 2023.

  • Kamei A, Sato R, Thornton R. Effect of pregnancy tests on demand for family planning: evidence from a randomized controlled trial in Uganda. Reprod Health. 2021 Nov 15;18(1):231. doi: 10.1186/s12978-021-01279-5.

MeSH Terms

Interventions

Pregnancy Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Obstetrical and GynecologicalInvestigative Techniques

Study Officials

  • Rebecca Thornton, Ph.D.

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

June 5, 2019

Study Start

May 14, 2019

Primary Completion

September 10, 2019

Study Completion

December 31, 2020

Last Updated

November 13, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations