Community-based Provision of Urine Pregnancy Tests as Linkage to Reproductive Health Services
Condition: Prenatal Care Late; Contraceptive Usage; Pregnancy Complication
MeSH terms: Pregnancy Complications
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Urine Pregnancy Test; CHV-based post-test counseling & referral; Phone-based post-test counseling & referral
Intervention type(s): Diagnostic Test; Behavioral; Behavioral
Intervention description(s): CHV will provide all participants with in-person urine pregnancy tests (UPTs); CHVs will provide in-person post-test counseling & referral to care; Participants will call/SMS or be called/SMSed for phone-based counseling & referral to care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel, non-blinded, patient preference model.
Masking: None (Open Label)
Primary purpose: Diagnostic