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

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Indiana University

Status

Completed

Conditions

Pregnancy Complication
Contraceptive Usage
Prenatal Care Late

Treatments

Behavioral: CHV-based post-test counseling & referral
Behavioral: Phone-based post-test counseling & referral
Diagnostic Test: Urine Pregnancy Test

Study type

Interventional

Funder types

Other

Identifiers

NCT03626597
0003029

Details and patient eligibility

About

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.

Full description

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.

Enrollment

308 patients

Sex

Female

Ages

15 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

CHV participants:

Inclusion:

  • Approved and designated CHV by their respective county
  • Has been in their role for at least 1 year Exclusion: if they do not meet the inclusion criteria

Women participants:

Inclusion Criteria:

  • 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

308 participants in 2 patient groups

CHV-provided post-test counseling & referral
Active Comparator group
Description:
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.
Treatment:
Diagnostic Test: Urine Pregnancy Test
Behavioral: CHV-based post-test counseling & referral
Phone-based post-test counseling & referral
Active Comparator group
Description:
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.
Treatment:
Behavioral: Phone-based post-test counseling & referral
Diagnostic Test: Urine Pregnancy Test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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