Improving Person Centered Care for Abortion Clients in India (SPARQ_ACI)

May 22, 2023 updated by: University of California, San Francisco

Strengthening Patient-Centered Accessibility, Respect, and Quality of Care for Abortion Clients in UP, India

The purpose of this study is to understand the effect of providing pharmacists in UP, India with additional information about medication abortion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study evaluates whether providing pharmacists with additional information about medication abortion can improve abortion person-centered care for women accessing MA at these sites.

Study Type

Interventional

Enrollment (Actual)

283

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pharmacist providing medication abortion within Lucknow, Kanpur, Unnao
  • Agreed to participate

Exclusion Criteria:

  • Pharmacists not providing medication abortion within Lucknow, Kanpur, Unnao
  • Did not agree to participate

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Pharmacists who received in the intervention.
Behavioral: 2 Page Information Sheet
2 page information sheet about medication abortion
No Intervention: Control
Pharmacists who did not received in the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in knowledge about medication abortion
Time Frame: baseline compared to 6-months after intervention
self-reported survey (dose, time, side effects, complications)
baseline compared to 6-months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider behavior when providing medication abortion (MA) to clients
Time Frame: 3-months post intervention
Information provided to mystery clients regarding MA (dose, time, side effects, complications)
3-months post intervention
Interest and satisfaction with intervention
Time Frame: 6-months after intervention
self-reported survey on interest and satisfaction
6-months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Public Health Foundation of India

Investigators

  • Principal Investigator: Nadia Diamond-Smith, PhD, University of California, San Francisco

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)

November 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-18008_India Abortion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data from this evaluation will be shared on the data repository Dryad.

IPD Sharing Time Frame

Data will be made available following the publication of the first journal article based on this data.

IPD Sharing Access Criteria

Anyone who has access to Dryad

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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