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.

Study Overview

• Status: Completed
• Conditions: Contraceptive Usage; Prenatal Care Late; Pregnancy Complication
• Intervention / Treatment: Diagnostic test: Urine Pregnancy Test; Behavioral: CHV-based post-test counseling & referral; Behavioral: Phone-based post-test counseling & referral

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.

• Study Type: Interventional
• Enrollment (Actual): 308
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Eldoret, Kenya, 30100
    • Moi University/MTRH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Active Comparator: 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.	Diagnostic test: Urine Pregnancy Test; CHV will provide all participants with in-person urine pregnancy tests (UPTs); Behavioral: Phone-based post-test counseling & referral; Participants will call/SMS or be called/SMSed for phone-based counseling & referral to care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization of care	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	1-3 months post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction with CHV-based UPT provision	Participant self-report of satisfaction with CHV-based UPT provision on scale of very unsatisfied to very satisfied	1-3 months post-enrollment
Participant preference for CHV-based vs phone-based post-test counseling and referral	Proportion of participants who choose CHV-based vs. phone-based post-test counseling and referral	At the time of enrollment
Number of UPTs provided per month	CHV self-report of total number of UPTs provided per month (including participants & women who declined enrollment or did not meet inclusion criteria)	Monthly, thoughout the study period (estimated 10 months)
CHV comfort with UPT provision and post-test counseling and referral	CHV self-report of of comfort with UPT provision and post-test counseling and referral on a scale from not comfortable to very comfortable	At the time of time of UPT provision
Participant utilization of phone-based post-test counseling and referral	Proportion of participants who call/SMS and respond to call/SMS for phone-based post-test counseling and referral	1-3 months post-enrollment
Results of UPTs	Proportion of negative vs. positive UPT results	1-3 months post-enrollment
Gestational age at first ANC visit	Participant self-report of gestational age at first ANC visit for women with positive UPT who attended ANC visit (reported as mean and range)	1-3 months post-enrollment
initiation of FP and method of FP	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)	1-3 months post-enrollment

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Moi University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: July 29, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications
• Other Study ID Numbers: 0003029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No