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

NCT03626597 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2024-12-17

No results posted yet for this study

Summary

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.

Conditions

  • Prenatal Care Late
  • Contraceptive Usage
  • Pregnancy Complication

Interventions

DIAGNOSTIC_TEST

Urine Pregnancy Test

CHV will provide all participants with in-person urine pregnancy tests (UPTs)

BEHAVIORAL

CHV-based post-test counseling & referral

CHVs will provide in-person post-test counseling \& referral to care

BEHAVIORAL

Phone-based post-test counseling & referral

Participants will call/SMS or be called/SMSed for phone-based counseling \& referral to care

Sponsors & Collaborators

  • Moi University

    collaborator OTHER
  • Indiana University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-13
Primary Completion
2019-09-01
Completion
2019-11-30

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03626597 on ClinicalTrials.gov