Clinical trial NCT04206514: Improving Person Centered Care for Post Abortion Patients in Kenya
Official title: Strengthening Patient-Centered Accessibility, Respect, and Quality of Care for Post Abortion Care Through Peer and Nurse Based Phone Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Health
Keywords: post abortion
person-centered care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Innovations for Poverty Action
name: Marie Stopes International
First posted: 2019-12-20
Enrollment: 371
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Person-Centered Abortion Scale Score
timeFrame: baseline
measure: Person-Centered Abortion Scale Score
timeFrame: 2 weeks post-procedure
measure: Person-Centered Abortion Scale Score
timeFrame: 4 weeks post-procedure
Secondary outcomes:
measure: Post abortion family planning counseling
timeFrame: baseline
measure: Post-abortion family planning uptake
timeFrame: baseline
measure: Perceived social support
timeFrame: baseline
measure: Perceived abortion stigma
timeFrame: baseline
measure: Mental Health
timeFrame: baseline
measure: Post-abortion family planning uptake
timeFrame: 2 weeks post-procedure
measure: Mental Health
timeFrame: 2-weeks post procedure
measure: Post-abortion family planning uptake
timeFrame: 4 weeks post-procedure
measure: Perceived social support
timeFrame: 4 weeks post-procedure
measure: Perceived abortion stigma
timeFrame: 4 weeks post procedure
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Marie Stopes International Kenya
Study officials:
affiliation: University of California, San Francisco/University of California, Los Angeles
name: May Sudhinaraset, PhD
role: PRINCIPAL_INVESTIGATOR
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