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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626597
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
Moi University
Information provided by (Responsible Party):
Caitlin Bernard, Indiana University

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.

Condition or disease Intervention/treatment Phase
Prenatal Care Late Contraceptive Usage Pregnancy Complication Diagnostic Test: Urine Pregnancy Test Behavioral: CHV-based post-test counseling & referral Behavioral: Phone-based post-test counseling & referral Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel, non-blinded, patient preference model.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Community-based Provision of Urine Pregnancy Tests as Linkage to Reproductive Health Services
Actual Study Start Date : October 13, 2018
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Utilization of care [ Time Frame: 1-3 months post-enrollment ]
    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


Secondary Outcome Measures :
  1. Participant Satisfaction with CHV-based UPT provision [ Time Frame: 1-3 months post-enrollment ]
    Participant self-report of satisfaction with CHV-based UPT provision on scale of very unsatisfied to very satisfied

  2. Participant preference for CHV-based vs phone-based post-test counseling and referral [ Time Frame: At the time of enrollment ]
    Proportion of participants who choose CHV-based vs. phone-based post-test counseling and referral

  3. Number of UPTs provided per month [ Time Frame: Monthly, thoughout the study period (estimated 10 months) ]
    CHV self-report of total number of UPTs provided per month (including participants & women who declined enrollment or did not meet inclusion criteria)

  4. CHV comfort with UPT provision and post-test counseling and referral [ Time Frame: At the time of time of UPT provision ]
    CHV self-report of of comfort with UPT provision and post-test counseling and referral on a scale from not comfortable to very comfortable

  5. Participant utilization of phone-based post-test counseling and referral [ Time Frame: 1-3 months post-enrollment ]
    Proportion of participants who call/SMS and respond to call/SMS for phone-based post-test counseling and referral

  6. Results of UPTs [ Time Frame: 1-3 months post-enrollment ]
    Proportion of negative vs. positive UPT results

  7. Gestational age at first ANC visit [ Time Frame: 1-3 months post-enrollment ]
    Participant self-report of gestational age at first ANC visit for women with positive UPT who attended ANC visit (reported as mean and range)

  8. initiation of FP and method of FP [ Time Frame: 1-3 months post-enrollment ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must self-represent as female
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626597


Locations
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Kenya
Moi University/MTRH
Eldoret, Kenya, 30100
Sponsors and Collaborators
Indiana University
Moi University
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Responsible Party: Caitlin Bernard, Assistant Professor, Obstetrics & Gynecology, Indiana University
ClinicalTrials.gov Identifier: NCT03626597    
Other Study ID Numbers: 0003029
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy Complications