Contraceptive Usage Clinical Trial
Official title:
Community-based Provision of Urine Pregnancy Tests as Linkage to Reproductive Health Services
Verified date | March 2020 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Moi University/MTRH | Eldoret |
Lead Sponsor | Collaborator |
---|---|
Indiana University | Moi University |
Kenya,
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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