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Improving Person-Centered Care for Family Planning in India (SPARQ_FPI)

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: NCT04206527
Recruitment Status : Completed
First Posted : December 20, 2019
Last Update Posted : December 20, 2019
Sponsor:
Collaborator:
Population Services International
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
To evaluate the impact of a training to ASHAs on person-centered care (PCC) for family planning (FP).

Condition or disease Intervention/treatment Phase
Family Planning Behavioral: Training of AHSAs on PCC for FP Behavioral: Enhanced FP training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Strengthening People-centered Accessibility, Respect, and Quality for Family Planning Services in India
Actual Study Start Date : April 26, 2019
Actual Primary Completion Date : June 24, 2019
Actual Study Completion Date : June 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Intervention - Women
Women who receive enhanced FP counseling from an ASHA
Behavioral: Training of AHSAs on PCC for FP
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
Behavioral: Enhanced FP training
Participation in an enhanced FP training including PCC

No Intervention: Control ASHA
ASHA who receive standard FP training



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04206527


Locations
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India
Population Services International
Lucknow, Uttar Pradesh, India
Sponsors and Collaborators
University of California, San Francisco
Population Services International
Investigators
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Study Director: Nadia Diamond-Smith, PhD University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04206527    
Other Study ID Numbers: 18-25950
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
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
Keywords provided by University of California, San Francisco:
Person-Centered Care