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

NCT ID: NCT03626597

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-13

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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Kenyan families experience persistently high rates of maternal and neonatal morbidity and mortality, which disproportionately affects women with low educational attainment and income 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 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 investigators' proposal includes a multi-phase process to collect qualitative data through a needs assessment, use community input to develop and implement a pilot study 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. 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.

Expected outcomes include important qualitative data regarding the needs and preferences of women and CHVs to improve reproductive health services. Additionally, the investigators will perform a quantitative comparison of CHV-provided and phone-based post-test counseling to inform further research projects and CHV services. The investigators will plan to publish this clinical research in international peer-reviewed journals and to host community events to share the results of the study. The investigators anticipate that the outcomes from this pilot research will allow them to apply for research funding for expansion of this intervention throughout the catchment area to evaluate its effects on key population health outcomes, including maternal and neonatal mortality.

Conditions

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Prenatal Care Late Contraceptive Usage Pregnancy Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel, non-blinded, patient preference model.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CHV-provided post-test counseling & referral

The CHV will provide the woman with the urine pregnancy test and collect baseline information. If the woman desires enrollment in Arm 1 (CHV-provided post-test counseling and referral), the CHV will provide all post-test counseling and referral based on training provided. This may occur at the time of enrollment or at a later time, as preferred by the woman.

Group Type ACTIVE_COMPARATOR

Urine Pregnancy Test

Intervention Type DIAGNOSTIC_TEST

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

CHV-based post-test counseling & referral

Intervention Type BEHAVIORAL

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

Phone-based post-test counseling & referral

The CHV will provide the woman with the urine pregnancy test and collect baseline information. If the woman desires enrollment in Arm 2 (phone-based post-test counseling and referral), the CHV will provide the woman with a phone number which she may call or short message service (SMS) to receive post-test counseling and referral. If the study team does not receive a call or SMS from the woman within one week, our research assistant will phone and/or SMS the participant to provide phone-based post-test counseling and referral.

Group Type ACTIVE_COMPARATOR

Urine Pregnancy Test

Intervention Type DIAGNOSTIC_TEST

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

Phone-based post-test counseling & referral

Intervention Type BEHAVIORAL

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

Interventions

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Urine Pregnancy Test

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

Intervention Type DIAGNOSTIC_TEST

CHV-based post-test counseling & referral

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

Intervention Type BEHAVIORAL

Phone-based post-test counseling & referral

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Approved and designated CHV by their respective county

Women participants:


* Women aged 15-45, inclusive
* Desire to use a urine pregnancy test for any reason.
* Have availability of a phone.
* Agree to enrollment in the study and to be contacted for data collection
* Conversant in Kiswahili or English

Exclusion Criteria

• Physical or mental illness that precludes study involvement
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Moi University

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Caitlin Bernard

Assistant Professor, Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Moi University/MTRH

Eldoret, , Kenya

Site Status

Countries

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Kenya

Other Identifiers

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0003029

Identifier Type: -

Identifier Source: org_study_id