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Completed

NCT Number: NCT03626597

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

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.

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Key information

Conditions

Prenatal Care Late Behavior Contraception Behavior Contraceptive Usage Female Urogenital Diseases and Pregnancy Complications Pregnancy Complication Pregnancy Complications Reproductive Behavior Urogenital Diseases

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moi University/MTRH

Eldoret, 30100, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine pregnancy test

Diagnostic Test

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

CHV-based post-test counseling & referral

Behavioral

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

Phone-based post-test counseling & referral

Behavioral

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

Primary outcomes

  1. Utilization of care

    Time frame: 1-3 months post-enrollment

    Defined as proportion of participants who self-report attendance to at least one Antenatal Care (ANC) visit for women with positive UPT or Family Planning (FP) clinic visit for women with negative UPT

Secondary outcomes

  1. Participant Satisfaction with CHV-based UPT provision

    Time frame: 1-3 months post-enrollment

    Participant self-report of satisfaction with CHV-based UPT provision on scale of very unsatisfied to very satisfied

  2. Participant preference for CHV-based vs phone-based post-test counseling and referral

    Time frame: At the time of enrollment

    Proportion of participants who choose CHV-based vs. phone-based post-test counseling and referral

  3. Number of UPTs provided per month

    Time frame: Monthly, thoughout the study period (estimated 10 months)

    CHV self-report of total number of UPTs provided per month (including participants & women who declined enrollment or did not meet inclusion criteria)

  4. CHV comfort with UPT provision and post-test counseling and referral

    Time frame: At the time of time of UPT provision

    CHV self-report of of comfort with UPT provision and post-test counseling and referral on a scale from not comfortable to very comfortable

  5. Participant utilization of phone-based post-test counseling and referral

    Time frame: 1-3 months post-enrollment

    Proportion of participants who call/SMS and respond to call/SMS for phone-based post-test counseling and referral

  6. Results of UPTs

    Time frame: 1-3 months post-enrollment

    Proportion of negative vs. positive UPT results

  7. Gestational age at first ANC visit

    Time frame: 1-3 months post-enrollment

    Participant self-report of gestational age at first ANC visit for women with positive UPT who attended ANC visit (reported as mean and range)

  8. initiation of FP and method of FP

    Time frame: 1-3 months post-enrollment

    Participant self-report of initiation of family planning and method of family planning initiated (reported as proportion of women with negative UPT who initiated FP and proportion initiating each method of FP)

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Moi University

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2018
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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