SPARQ_FPI: Improving Person-Centered Care for Family Planning in India

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT04206527
• Collaborator: Population Services International (Other)
• Enrollment: 1,104
• Location: 1
• Arms: 4
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 569.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Apr 26, 2019
• Actual Primary Completion Date: Jun 24, 2019
• Actual Study Completion Date: Jun 24, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Person-centered Family Planning Scale Score [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 [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 [3-months after first FP counseling with ASHA]

   Self-report of uptake of a FP method; Yes/No/I Don't remember

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Population Services International	Lucknow	Uttar Pradesh	India

Sponsors and Collaborators

• University of California, San Francisco
• Population Services International

Investigators

• Study Director: Nadia Diamond-Smith, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04206527
• Other Study ID Numbers: 18-25950
• First Posted: Dec 20, 2019
• Last Update Posted: Dec 20, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Dec 20, 2019