NCT04307641

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
283

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

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

November 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
Last Updated

May 24, 2023

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

March 10, 2020

Last Update Submit

May 22, 2023

Conditions

Reproductive Health

Keywords

abortionperson-centered care

Outcome Measures

Primary Outcomes (1)

  • Change in knowledge about medication abortion

    self-reported survey (dose, time, side effects, complications)

    baseline compared to 6-months after intervention

Secondary Outcomes (2)

  • Provider behavior when providing medication abortion (MA) to clients

    3-months post intervention

  • Interest and satisfaction with intervention

    6-months after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Pharmacists who received in the intervention.

Behavioral: 2 Page Information Sheet

Control

NO INTERVENTION

Pharmacists who did not received in the intervention.

Interventions

2 Page Information SheetBEHAVIORAL

2 page information sheet about medication abortion

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Nadia Diamond-Smith, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 13, 2020

Study Start

November 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

May 24, 2023

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

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

Time Frame
Data will be made available following the publication of the first journal article based on this data.
Access Criteria
Anyone who has access to Dryad