Prenatal Care LateNCT03626597
Community-based Provision of Urine Pregnancy Tests as Linkage to Reproductive Health Services
A study testing Urine Pregnancy Test, CHV-based post-test counseling & referral and Phone-based post-test counseling & referral in people with Prenatal Care Late and Contraceptive Usage, run by Indiana University at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Care Late, Contraceptive Usage, Pregnancy Complication
- What is being tested?
- Urine Pregnancy Test, CHV-based post-test counseling & referral and Phone-based post-test counseling & referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteKenya
- Study dates
- 13 Oct 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
- 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
Who cannot join
- Physical or mental illness that precludes study involvement
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Urine Pregnancy Test, CHV-based post-test counseling & referral, Phone-based post-test counseling & referral
- Medical subject headings
- Contraception Behavior, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine Pregnancy TestDiagnostic test
CHV will provide all participants with in-person urine pregnancy tests (UPTs)
CHV-based post-test counseling & referralBehavioural
CHVs will provide in-person post-test counseling \& referral to care
Phone-based post-test counseling & referralBehavioural
Participants will call/SMS or be called/SMSed for phone-based counseling \& referral to care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Urine Pregnancy Test; Behavioral: Phone-based post-test counseling & referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-3 months post-enrollment
Secondary outcomes (8)
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
Measured: 1-3 months post-enrollment
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
Measured: At the time of enrollment
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)
Measured: Monthly, thoughout the study period (estimated 10 months)
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
Measured: At the time of time of UPT provision
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
Measured: 1-3 months post-enrollment
Results of UPTs
Proportion of negative vs. positive UPT results
Measured: 1-3 months post-enrollment
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)
Measured: 1-3 months post-enrollment
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)
Measured: 1-3 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start13 Oct 2018
- Primary completion1 Sep 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal Care LateStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, non-blinded, patient preference model.
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi University
- Responsible party
- Principal investigator, Caitlin Bernard, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626597
- Sponsor's protocol ID
- 0003029
- Status last verified
- Dec 2024
- First submitted
- 29 Jul 2018
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Provision of Urine Pregnancy Tests as Linkage to Reproductive Health Services
- ClinicalTrials.gov ID
- NCT03626597
- Acronym / sponsor ID
- 0003029
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Moi University
- Study start
- 13 Oct 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel, non-blinded, patient preference model.
| Arm | Type | Receives |
|---|---|---|
| CHV-provided post-test counseling & referral | Active comparator | Diagnostic Test: Urine Pregnancy Test, Behavioral: CHV-based post-test counseling & referralThe 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. |
| Phone-based post-test counseling & referral | Active comparator | Diagnostic Test: Urine Pregnancy Test, Behavioral: Phone-based post-test counseling & referralThe 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. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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 aged 15-45, inclusive
- Desire to use a urine pregnancy test for any reason.
- Have availability of a phone.
Key exclusion criteria (1 listed)
- Physical or mental illness that precludes study involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine Pregnancy TestCHV will provide all participants with in-person urine pregnancy tests (UPTs) | Diagnostic test | CHV-provided post-test counseling & referral, Phone-based post-test counseling & referral |
| CHV-based post-test counseling & referralCHVs will provide in-person post-test counseling \& referral to care | Behavioural | CHV-provided post-test counseling & referral |
| Phone-based post-test counseling & referralParticipants will call/SMS or be called/SMSed for phone-based counseling \& referral to care | Behavioural | Phone-based post-test counseling & referral |
Primary outcome
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
8 secondary outcomes
Participant Satisfaction with CHV-based UPT provision
Time frame: 1-3 months post-enrollment
Participant preference for CHV-based vs phone-based post-test counseling and referral
Time frame: At the time of enrollment
Number of UPTs provided per month
Time frame: Monthly, thoughout the study period (estimated 10 months)
CHV comfort with UPT provision and post-test counseling and referral
Time frame: At the time of time of UPT provision
Participant utilization of phone-based post-test counseling and referral
Time frame: 1-3 months post-enrollment
Results of UPTs
Time frame: 1-3 months post-enrollment
Gestational age at first ANC visit
Time frame: 1-3 months post-enrollment
initiation of FP and method of FP
Time frame: 1-3 months post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine Pregnancy Test, CHV-based post-test counseling & referral and Phone-based post-test counseling & referral in people with Prenatal Care Late and Contraceptive Usage, run by Indiana University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization of care (time frame: 1-3 months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.