NCT03626597

Community-based Provision of Urine Pregnancy Tests as Linkage to Reproductive Health Services

Completed NA Last updated 17 December 2024

What this trial tests

NA trial testing Urine Pregnancy Test in Prenatal Care Late in 308 participants. Completed in 30 November 2019.

Timeline

13 October 2018

Primary endpoint
1 September 2019

30 November 2019

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	308
Start date	13 October 2018
Primary completion	1 September 2019
Estimated completion	30 November 2019
Sites	1 location across Kenya

Drugs / interventions tested

• Urine Pregnancy Test
• CHV-based post-test counseling & referral
• Phone-based post-test counseling & referral

Conditions studied

• Prenatal Care Late — all drugs for Prenatal Care Late →
• Contraceptive Usage — all drugs for Contraceptive Usage →
• Pregnancy Complication — all drugs for Pregnancy Complication →

Sponsor

Indiana University

Who can join

Adults 15 to 45, female only, with Prenatal Care Late or Contraceptive Usage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Kenyan families experience persistently high rates of maternal and neonatal mortality, which disproportionately affects women with low income and education and those who live far from health services. Key proven interventions include prevention of pregnancy and birth spacing, early entry to antenatal care, and facility delivery. However, creative, cost-effective interventions are urgently needed to link particularly vulnerable populations with these important health services. Previous research has shown that equipping community health volunteers (CHVs) with a tool as simple as a urine pregnancy test and training to provide post-test counseling is effective in improving linkages to antenatal care and family planning services. The invesitgators' proposal includes a multi-phase process to collect qualitative data through a needs assessment (Phase 1), use community input to develop (Phase 2) and implement a pilot intervention study (Phase 3) assessing the ability of CHV-based provision of urine pregnancy tests with CHV-provided and phone-based post-test counseling to link women with antenatal care and family planning services, and collect qualitative program evaluation data (Phase 4). This will provide much-needed information for how to effectively utilize and strengthen CHVs as part of a sustainable reproductive health care delivery system to improve maternal and neonatal mortality. The broad objectives are to determine whether the use of community-based provision of urine pregnancy tests with post-test counseling and referral to care is acceptable to community health volunteers (CHVs) and participants and to determine which method of post-test counseling and referral to care, CHV-provided or phone-based, is more acceptable and more effective. Participant outcomes, including the primary outcome of utilization of ANC or family planning care, will be measured by telephone questionnaires one to three months post-enrollment. CHV outcomes will be determined by telephone questionnaires as well as review of CHV log books.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.