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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03626597
Other study ID # 0003029
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2018
Est. completion date November 30, 2019

Study information

Verified date March 2020
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 308
Est. completion date November 30, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 45 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Kenya Moi University/MTRH Eldoret

Sponsors (2)

Lead Sponsor Collaborator
Indiana University Moi University

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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)
Secondary 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
Secondary 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
Secondary Results of UPTs Proportion of negative vs. positive UPT results 1-3 months post-enrollment
Secondary 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
Secondary 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
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