Clinical trial NCT03626597: Community-based Provision of Urine Pregnancy Tests as Linkage to Reproductive Health Services
Official title: Community-based Provision of Urine Pregnancy Tests as Linkage to Reproductive Health Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Care Late
Contraceptive Usage
Pregnancy Complication
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Moi University
First posted: 2018-08-13
Enrollment: 308
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel, non-blinded, patient preference model.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Utilization of care
timeFrame: 1-3 months post-enrollment
Secondary outcomes:
measure: Participant Satisfaction with CHV-based UPT provision
timeFrame: 1-3 months post-enrollment
measure: Participant preference for CHV-based vs phone-based post-test counseling and referral
timeFrame: At the time of enrollment
measure: Number of UPTs provided per month
timeFrame: Monthly, thoughout the study period (estimated 10 months)
measure: CHV comfort with UPT provision and post-test counseling and referral
timeFrame: At the time of time of UPT provision
measure: Participant utilization of phone-based post-test counseling and referral
timeFrame: 1-3 months post-enrollment
measure: Results of UPTs
timeFrame: 1-3 months post-enrollment
measure: Gestational age at first ANC visit
timeFrame: 1-3 months post-enrollment
measure: initiation of FP and method of FP
timeFrame: 1-3 months post-enrollment
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi University/MTRH
Study officials:
References: