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

NCT03626597 | Completed

• 1 other identifier: 0003029
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prenatal Care Late; Contraceptive Usage; Pregnancy Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Participant Satisfaction with CHV-based UPT provision

  1-3 months post-enrollment

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

  At the time of enrollment

• Number of UPTs provided per month

  Monthly, thoughout the study period (estimated 10 months)

• CHV comfort with UPT provision and post-test counseling and referral

  At the time of time of UPT provision

• Participant utilization of phone-based post-test counseling and referral

  1-3 months post-enrollment

Study Arms (2)

CHV-provided post-test counseling & referral

ACTIVE COMPARATOR

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; Behavioral: CHV-based post-test counseling & referral

Phone-based post-test counseling & referral

ACTIVE COMPARATOR

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; Behavioral: Phone-based post-test counseling & referral

Interventions

Urine Pregnancy Test DIAGNOSTIC_TEST

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

CHV-provided post-test counseling & referral; Phone-based post-test counseling & referral

CHV-based post-test counseling & referral BEHAVIORAL

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

CHV-provided post-test counseling & referral

Phone-based post-test counseling & referral BEHAVIORAL

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

Phone-based post-test counseling & referral

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: Participants must self-represent as female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Approved and designated CHV by their respective county

You may not qualify if:

• 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
• Physical or mental illness that precludes study involvement

Sponsors & Collaborators

• Indiana University: lead
• Moi University: collaborator

Study Sites (1)

Moi University/MTRH

Eldoret, 30100, Kenya

Location

MeSH Terms

Conditions

Contraception Behavior; Pregnancy Complications

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Obstetrics & Gynecology

Model Details: Parallel, non-blinded, patient preference model.

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 13, 2018
• Study Start: October 13, 2018
• Primary Completion: September 1, 2019
• Study Completion: November 30, 2019
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)