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

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.

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

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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