Improving Person Centered Care for Post Abortion Patients in Kenya (SPARQ_PACK)

January 10, 2020 updated by: University of California, San Francisco

Strengthening Patient-Centered Accessibility, Respect, and Quality of Care for Post Abortion Care Through Peer and Nurse Based Phone Support

The purpose of this study is to understand the effect of a phone based post-abortion intervention on the experience of post-abortion care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study evaluates whether personalized text messages and phone calls to post abortion women can improve post abortion person-centered care, perceived social support, post-abortion family planning, and reduce perceptions of social stigma and stress. Women were randomized to one of three study arms: personalized communication with a peer counselor or nurse who received person-centered care (PCC) training, or a control arm where participants received the standard of care.

Study Type

Interventional

Enrollment (Actual)

371

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Marie Stopes International Kenya

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

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women of reproductive age
  • Had an Safe Abortion (SA)/Post Abortion Care (PAC) procedure at one of six private clinics that day
  • Has her own cellphone that is WhatsApp compatible and will have access to this phone for the next four weeks
  • Willing to receive receive short message service (SMS) messages and phone calls from an Marie Stopes Kenya (MSK) or Innovation for Poverty Action (IPA) professional
  • Able to communicate in English and/or Swahili
  • Willing and able to comprehend and give informed consent
  • Willing to participate in a baseline survey immediately after providing consent
  • Willing to be followed up by phone at two weeks and four weeks post procedure for a 15-minute survey at each time-point
  • Has not already participated in this study

Exclusion Criteria:

  • Is not a women of reproductive age
  • Did not have an SA/PAC procedure at one of six private clinics that day
  • Does not have her own cellphone that is WhatsApp compatible and will have access to this phone for the next four weeks
  • Is not willing to SMS messages and phone calls from an MSK/IPA professional
  • Is not able to communicate in English and/or Swahili
  • Is not willing or is not able to comprehend and give informed consent
  • Is not willing to participate in a baseline survey immediately after providing consent
  • Is not willing to be followed up by phone at two weeks and four weeks post procedure for a 15-minute survey at each time-point
  • Has already participated in this study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer Counselor
Participants receive personalized text messages and phone calls from a peer counselor- a women who had an abortion and was trained in post abortion care and PCC
Behavioral: Person Centered Care - Post Abortion Support
Post abortion phone based support
Experimental: Nurse
Participants receive personalized text messages and phone calls from a nurse trained in post abortion care and PCC
Behavioral: Person Centered Care - Post Abortion Support
Post abortion phone based support
No Intervention: control
Participants receive the standard of care for post-abortion patients in Kenya.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Person-Centered Abortion Scale Score
Time Frame: baseline
Survey conducted with women: self-report of experiences of PCC. Possible range 0-100; higher the score, better the experience
baseline
Person-Centered Abortion Scale Score
Time Frame: 2 weeks post-procedure
Survey conducted with women: self-report of experiences of PCC. Possible range 0-100; higher the score, better the experience
2 weeks post-procedure
Person-Centered Abortion Scale Score
Time Frame: 4 weeks post-procedure
Survey conducted with women: self-report of experiences of PCC. Possible range 0-100; higher the score, better the experience
4 weeks post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post abortion family planning counseling
Time Frame: baseline
Self-report if women received counseling on family planning (Yes/No)
baseline
Post-abortion family planning uptake
Time Frame: baseline
Self-report of uptake of family planning (Yes/No/Refused to answer)
baseline
Perceived social support
Time Frame: baseline
Medical Outcomes Study-Social Support 15-item Scale (MOS-SSS): 18-90 where higher scores indicate greater social support
baseline
Perceived abortion stigma
Time Frame: baseline
The Individual Level Abortion Stigma Scale (ILAS Scale) Abbreviated 3-item Scale: 0-9 where higher scores indicate greater worry about stigma
baseline
Mental Health
Time Frame: baseline
Mental Health Inventory (MHI-5) scale; 0-100 with higher scores indicating better mental health
baseline
Post-abortion family planning uptake
Time Frame: 2 weeks post-procedure
self-report of uptake of family planning (Yes/No/Refused to answer)
2 weeks post-procedure
Mental Health
Time Frame: 2-weeks post procedure
Mental Health Inventory (MHI-5) scale; 0-100 with higher scores indicating better mental health
2-weeks post procedure
Post-abortion family planning uptake
Time Frame: 4 weeks post-procedure
self-report of uptake of family planning (Yes/No/Refused to answer)
4 weeks post-procedure
Perceived social support
Time Frame: 4 weeks post-procedure
Medical Outcomes Study-Social Support 15-item Scale (MOS-SSS): 18-90 where higher scores indicate greater social support
4 weeks post-procedure
Perceived abortion stigma
Time Frame: 4 weeks post procedure
The Individual Level Abortion Stigma Scale (ILAS Scale) Abbreviated 3-item Scale: 0-9 where higher scores indicate greater worry about stigma
4 weeks post procedure

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

Innovations for Poverty Action
Marie Stopes International

Investigators

  • Principal Investigator: May Sudhinaraset, PhD, University of California, San Francisco/University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 27, 2018

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

December 18, 2018

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 18, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-18008_Kenya Abortion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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