Plain English Summary
Background and study aims
In Indonesia, the provision of induced abortions is highly restricted, and abortion is technically only allowed in cases where a woman’s life is at risk. In settings where abortion is legally restricted, as well as where it is permitted but not widely accessible, women are increasingly choosing medications such as mifepristone and/or misoprostol to terminate their pregnancies outside of the formal healthcare system. In contexts where mobile phones are common but healthcare access is limited, mobile health (mHealth) programs have been shown to increase knowledge and agency, and even demonstrate improvements in health outcomes.
Who can participate?
Women aged 15 and over who are pregnant at 13 weeks gestation or below
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive usual care from the safe abortion hotline, and get access to a smartphone application which contains further information about medication abortion.
Those in the second group receive stand care telephonic support from the hotline.
Participants are followed up after three weeks with an online questionnaire.
What are the possible benefits and risks of participating?
There no direct benefit to participating in the study. Risks include feeling uncomfortable answering sensitive questions, though participants can skip any question. There is a small risk of loss of privacy for participants who give others access to their smartphone, as it is possible that others may see the smartphone application or may see the survey link. To minimize these risks, the smartphone application is password protected, and participants are asked to set a passcode on their phone if they don’t already have one.
Where is the study run from?
Indonesia
When is the study starting and how long is it expected to run for?
May 2016 to December 2018
Who is funding the study?
David and Lucile Packard Foundation (USA)
Who is the main contact?
1. Dr Caitlin Gerdts (Scientific)
2. Ms Ruvani Jayaweera (Public
Trial website
Contact information
Type
Scientific
Primary contact
Dr Caitlin Gerdts
ORCID ID
http://orcid.org/0000-0002-2488-5072
Contact details
1330 Broadway Suite 1100
Oakland
94612
United States of America
Type
Public
Additional contact
Ms Ruvani Jayaweera
ORCID ID
http://orcid.org/0000-0003-0609-9892
Contact details
1330 Broadway Suite 1100
Oakland
94612
United States of America
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
INDO 05216
Study information
Scientific title
Effect of a smartphone application on abortion preparedness and feelings of support compared to standard counseling among callers to a safe abortion hotline in Indonesia seeking information on medication abortion
Acronym
Study hypothesis
The aim of the study is to evaluate the feasibility and acceptability of a smartphone application to support women who are self-managing their abortions with counseling support from a safe abortion hotline. We hypothesize that women who use the smartphone application along with telephonic support from a safe abortion hotline (intervention arm) will feel more supported and be more prepared for their abortion experience than those who receive telephonic support alone (control arm).
Ethics approval
Allendale Institutional Review Board, 28/04/2016, no public reference number available.
Study design
Single-center randomized control trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Abortion
Intervention
Eligible participants who contact a safe abortion hotline for information on first trimester medication abortion are randomized into two study arms:
Intervention Arm: participants in this group receive standard of care from the safe abortion hotline. This consists of comprehensive, reliable, and accurate information and support to women who are seeking information on how to self-manage their abortion. Participants in this group also have access to a third-party smartphone application which is downloaded via a link. This contains information on medication abortion protocols, what to expect, warning signs and complications, contraception, healthy relationships, and other sexual and reproductive health related topics.
Control Arm: Participants in this group receive standard care of telephonic support from hotline counselors, which includes compassionate, gestational specific counseling on evidence-based medication abortion protocols, what to expect, how to manage symptoms and side effects, and warning signs of complications.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1.Preparedness for abortion symptoms/what to expect
2. Confidence in following the abortion regimen
3. Feeling supported during the process
All outcome measures are assessed using an online questionnaire three weeks after randomization.
Secondary outcome measures
1. Number of times contacted the hotline during their abortion process
Overall trial start date
01/05/2016
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. At least 15 years old
2. Able to give informed consent
3. Able to speak Bahasa Indonesia or English
4. Contact the hotline seeking information about medications for induced abortion and are 13 weeks gestation or below
5. Starting a new medication abortion process
6. Own an Android or iPhone smartphone
7. Willing to download a third-party application and receive SMS messages
Participant type
Other
Age group
Mixed
Gender
Female
Target number of participants
500
Participant exclusion criteria
1. Call the hotline but have already started their abortion process
2. Aged younger than 15
3. Do not own a smartphone
Recruitment start date
01/02/2017
Recruitment end date
30/06/2018
Locations
Countries of recruitment
Indonesia
Trial participating centre
Safe abortion hotline
withheld because of privacy concerns
Indonesia
Funders
Funder type
Charity
Funder name
David and Lucile Packard Foundation
Alternative name(s)
David & Lucile Packard Foundation, The David and Lucile Packard Foundation, The David & Lucile Packard Foundation, Packard Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal, and submission to sexual and reproductive health focused academic conferences.
IPD sharing statement:
Data will be held in a password protected computer by the Principal Investigator; participant level data will not be made available as participants were assured during the informed consent process that individual level information would not be shared outside of the study team.
Intention to publish date
01/02/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list