NCT04206514

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
371

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

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

August 27, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

December 18, 2019

Last Update Submit

January 10, 2020

Conditions

Keywords

post abortionperson-centered care

Outcome Measures

Primary Outcomes (3)

  • Person-Centered Abortion Scale Score

    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

    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

    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 Outcomes (10)

  • Post abortion family planning counseling

    baseline

  • Post-abortion family planning uptake

    baseline

  • Perceived social support

    baseline

  • Perceived abortion stigma

    baseline

  • Mental Health

    baseline

  • +5 more secondary outcomes

Study Arms (3)

Peer Counselor

EXPERIMENTAL

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

Nurse

EXPERIMENTAL

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

control

NO INTERVENTION

Participants receive the standard of care for post-abortion patients in Kenya.

Interventions

Post abortion phone based support

NursePeer Counselor

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marie Stopes International Kenya

Nairobi, Kenya

Location

Related Publications (25)

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    PMID: 23745828BACKGROUND
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    PMID: 18240894BACKGROUND
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    PMID: 9388397BACKGROUND
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    PMID: 12940388BACKGROUND
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    PMID: 16670219BACKGROUND
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    PMID: 12435559BACKGROUND
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    PMID: 11525394BACKGROUND
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    PMID: 26294220BACKGROUND
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    PMID: 26735332BACKGROUND
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    PMID: 10387503BACKGROUND
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    PMID: 20926226BACKGROUND
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    PMID: 27800111BACKGROUND
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    PMID: 19386134BACKGROUND

Study Officials

  • May Sudhinaraset, PhD

    University of California, San Francisco/University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

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 18, 2019

First Posted

December 20, 2019

Study Start

August 27, 2018

Primary Completion

December 18, 2018

Study Completion

December 18, 2018

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations