- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04206527
Improving Person-Centered Care for Family Planning in India (SPARQ_FPI)
December 18, 2019 updated by: University of California, San Francisco
Strengthening People-centered Accessibility, Respect, and Quality for Family Planning Services in India
To evaluate the impact of a training to ASHAs on person-centered care (PCC) for family planning (FP).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
ASHAs will be provided with a training on family planning (FP) counseling and method options.
Half of the group will receive additional trainings on person-centered care (PCC) principles and respectful care while the other half of the group will not receive this additional training.
Women working with both the control ASHAs (FP trained) and Interventions ASHAs (FP+PCC trained) will be surveyed following their interactions with the ASHA to understand the quality of their experience with the ASHA and whether the woman has taken up a FP method of her choice following interaction with the ASHA.
Study Type
Interventional
Enrollment (Actual)
1104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Uttar Pradesh
-
Lucknow, Uttar Pradesh, India
- Population Services International
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women aged 18-49
- Consented/agreed to participate
- Has met with a control or intervention ASHA at least once in the previous three months
Exclusion Criteria:
- Not a women aged 18-49
- Did not consent/agree to participate
- Has not met with a control or intervention ASHA at least once in the previous three months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention - Women
Women who receive enhanced FP counseling from an ASHA
|
ASHAs provided with training on FP methods and counseling plus PCC for FP
|
No Intervention: Control - Women
Women who receive standard FP counseling from an ASHA
|
|
Experimental: Intervention - ASHA
ASHA who receive enhanced FP counseling training
|
Participation in an enhanced FP training including PCC
|
No Intervention: Control ASHA
ASHA who receive standard FP training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Person-centered Family Planning Scale Score
Time Frame: 3-months after first FP counseling with ASHA
|
Survey conducted with women: self-report of experiences of care.
Possible range 0-43; higher the score the better the experience of care
|
3-months after first FP counseling with ASHA
|
Experience of providing FP counseling
Time Frame: at least 3-months after FP training
|
In-depth interviews with ASHAs from intervention and control arms to understand experience providing FP counseling
|
at least 3-months after FP training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Uptake of Family Planning
Time Frame: 3-months after first FP counseling with ASHA
|
Self-report of uptake of a FP method; Yes/No/I Don't remember
|
3-months after first FP counseling with ASHA
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Nadia Diamond-Smith, PhD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 26, 2019
Primary Completion (Actual)
June 24, 2019
Study Completion (Actual)
June 24, 2019
Study Registration Dates
First Submitted
December 17, 2019
First Submitted That Met QC Criteria
December 18, 2019
First Posted (Actual)
December 20, 2019
Study Record Updates
Last Update Posted (Actual)
December 20, 2019
Last Update Submitted That Met QC Criteria
December 18, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18-25950
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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