NCT04206527

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,104

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

December 17, 2019

Last Update Submit

December 18, 2019

Conditions

Keywords

Person-Centered Care

Outcome Measures

Primary Outcomes (2)

  • Person-centered Family Planning Scale Score

    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

    In-depth interviews with ASHAs from intervention and control arms to understand experience providing FP counseling

    at least 3-months after FP training

Secondary Outcomes (1)

  • Uptake of Family Planning

    3-months after first FP counseling with ASHA

Study Arms (4)

Intervention - Women

EXPERIMENTAL

Women who receive enhanced FP counseling from an ASHA

Behavioral: Training of AHSAs on PCC for FP

Control - Women

NO INTERVENTION

Women who receive standard FP counseling from an ASHA

Intervention - ASHA

EXPERIMENTAL

ASHA who receive enhanced FP counseling training

Behavioral: Enhanced FP training

Control ASHA

NO INTERVENTION

ASHA who receive standard FP training

Interventions

ASHAs provided with training on FP methods and counseling plus PCC for FP

Intervention - Women

Participation in an enhanced FP training including PCC

Intervention - ASHA

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-49
  • Consented/agreed to participate
  • Has met with a control or intervention ASHA at least once in the previous three months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Population Services International

Lucknow, Uttar Pradesh, India

Location

Related Publications (1)

  • Diamond-Smith N, McDonell C, Sahu AB, Roy KP, Giessler K. A mixed-methods evaluation of the impact of a person-centered family planning intervention for community health workers on family planning outcomes in India. BMC Health Serv Res. 2020 Dec 11;20(1):1139. doi: 10.1186/s12913-020-05995-9.

Study Officials

  • Nadia Diamond-Smith, PhD

    University of California, San Francisco

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 20, 2019

Study Start

April 26, 2019

Primary Completion

June 24, 2019

Study Completion

June 24, 2019

Last Updated

December 20, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations