Abortion, InducedNCT04290832
Developing and Testing Interventions to Address Conscientious Objection to Abortion Care in Mexico and South Africa
A study testing CO Intervention in people with Abortion, Induced and Abortion, Incomplete, run by Ipas at 2 sites in 2 countries.
Trial summary
The primary purpose of this research is to develop strategies and interventions to mitigate the impact of conscientious objection on women's access to safe abortion care in Mexico and South Africa using a user-centered design approach and test the feasibility and effectiveness of these interventions. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Abortion, Induced, Abortion, Incomplete
- What is being tested?
- CO Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Feb 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All staff currently working in selected health facilities
- Able to provide informed consent
- Doctors/anyone eligible to be an abortion provider working in selected health facilities
- Able to provide informed consent
Who cannot join
- Unable to provide informed consent
- Mexico
- Unable to provide informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Developing and Testing Interventions to Address Use of Conscientious Objection to Deny Women's Access to Abortion Care in Mexico and South Africa
The primary purpose of this research is to develop strategies and interventions to mitigate the impact of conscientious objection on women's access to safe abortion care in Mexico and South Africa using a user-centered design approach and test the feasibility and effectiveness of these interventions.
Read the detailed description
Conscientious objection (CO) is emerging as a growing barrier to abortion care, and evidence suggests that it is being incorrectly used as a justification for public sector medical providers and institutions to exempt themselves from their duties to provide essential reproductive health services for women. Given this, it is essential to better understand and address this misuse of CO and find ways to improve women's access to safe abortion services to prevent them from using unsafe methods which risk their health and lives.
This study will conduct formative research to more fully understand the problem of CO in Mexico and South Africa and use these findings to develop interventions and strategies to mitigate the impact of CO on women's access to safe abortion care using a user-centered design approach. Rapid randomized controlled trials will then be used to assess effectiveness of the interventions. The specific aims of this study are:
- Improve our understanding of CO and its impact on access and quality of abortion care from providers' and facility mangers' perspectives in Mexico, and South Africa.
- Develop strategies and interventions to mitigate the impact of CO on women's access to safe abortion care. Using the data collected, a multi-disciplinary Innovation Team will develop strategies and interventions to respond to the challenges posed by CO using a user-centered design approach.
- Rapid-test intervention prototypes. We will test selected strategies (prototypes) in Mexico, and South Africa with assessments to determine successes, and the feasibility of scaling up these approaches.
- Conditions
- Abortion, Induced, Abortion, Incomplete
- Being tested
- CO Intervention
- Medical subject headings
- Abortion, Incomplete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO InterventionBehavioural
South Africa: Values clarification and attitude transformation (VCAT) workshop with conscientious objection content, debrief session(s) with termination of pregnancy (TOP) providers to give them an opportunity to share concerns/challenges, meeting(s) with facility mangers to facilitate continued support and provision of TOP care
Mexico: Training on abortion and conscientious objection law, posters on law, offer of legal assistance for abortion providers, scholarship to attend conference awarded on basis of quality of abortion care
| Study group | Role | What they receive |
|---|---|---|
| CO intervention | Experimental | South Africa: All health facility staff working in facilities assigned to the intervention arm receive standard Ipas support (including monitoring of abortion service provision and support to Ipas-trained abortion providers) plus the CO intervention.
Mexico: Doctors/anyone eligible to be an abortion provider working in facilities assigned to the intervention arm receive the CO intervention. Receives: Behavioral: CO Intervention |
| Control | No intervention | South Africa: All health facility staff working in facilities assigned to the control arm receive standard Ipas support (including monitoring of abortion service provision and support to Ipas-trained abortion providers). Mexico: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior making it easier for women to access abortion care
Proportion of health facility staff exhibiting at least one behavior to make it easier for women to access abortion care (e.g. helped a woman find the abortion care unit, provided positive support to a woman seeking abortion care, gave accurate information to a woman seeking abortion care, etc.).
Measured: Past 30 days
Behavior making it more difficult for women to access abortion care
Proportion of health facility staff exhibiting at least one behavior to make it more difficult for women to access abortion care (e.g. gave incorrect directions to a woman seeking abortion care, told a woman abortion services were not available at the facility, tried to convince a woman that she should not have an abortion, etc.).
Measured: Past 30 days
Intention to provide abortion service, referral, or information
Proportion of health facility staff reporting they would provide abortion service, referral or information to women seeking abortion care in their health unit in the next few days if needed.
Measured: Next few days
Secondary outcomes (2)
Interest in attending an abortion care training
Proportion of providers (doctors, nurses, or midwives) reporting being interested in attending an abortion care training.
Measured: Assessed at baseline and at 30-day follow-up
Stigmatizing Attitudes Beliefs and Actions Scale (SABAS) score
Average Stigmatizing Attitudes Beliefs and Actions Scale (SABAS) score. The SABAS is a tool designed to measure abortion stigma at the individual and community level, ranging from a minimum of 18 to a maximum of 90. A higher score represents more stigmatizing attitudes and beliefs about women who have an abortion (worse outcome).
Measured: Assessed at baseline and at 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start13 Feb 2020
- Primary completion17 Mar 2020
- Study completion30 Jun 2020
Why it stopped: The study was stopped prematurely due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion, InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Pearson, PhD, MPH, Principal investigator, Ipas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290832
- Sponsor's protocol ID
- TIE_2020_01
- Status last verified
- Jul 2020
- First submitted
- 27 Feb 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jim A, Magwentshu M, Menzel J, Kung SA, August SA, van Rooyen J, Chingwende R, Pearson E. Stigma towards women requesting abortion and association with health facility staff facilitation and obstruction of abortion care in South Africa. Front Glob Womens Health. 2023 Jun 15;4:1142638. doi: 10.3389/fgwh.2023.1142638. eCollection 2023.
PubMed 37396569
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing Interventions to Address Use of Conscientious Objection to Deny Women's Access to Abortion Care in Mexico and South Africa
- ClinicalTrials.gov ID
- NCT04290832
- Acronym / sponsor ID
- TIE_2020_01
- Conditions
- Abortion, Induced, Abortion, Incomplete
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped prematurely due to the COVID-19 pandemic
- Enrolment
- 317 participants (actual)
- Lead sponsor
- IpasUniversity, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this research is to develop strategies and interventions to mitigate the impact of conscientious objection on women's access to safe abortion care in Mexico and South Africa using a user-centered design approach and test the feasibility and effectiveness of these interventions.
Detailed description
Conscientious objection (CO) is emerging as a growing barrier to abortion care, and evidence suggests that it is being incorrectly used as a justification for public sector medical providers and institutions to exempt themselves from their duties to provide essential reproductive health services for women. Given this, it is essential to better understand and address this misuse of CO and find ways to improve women's access to safe abortion services to prevent them from using unsafe methods which risk their health and lives.
This study will conduct formative research to more fully understand the problem of CO in Mexico and South Africa and use these findings to develop interventions and strategies to mitigate the impact of CO on women's access to safe abortion care using a user-centered design approach. Rapid randomized controlled trials will then be used to assess effectiveness of the interventions. The specific aims of this study are:
- Improve our understanding of CO and its impact on access and quality of abortion care from providers' and facility mangers' perspectives in Mexico, and South Africa.
- Develop strategies and interventions to mitigate the impact of CO on women's access to safe abortion care. Using the data collected, a multi-disciplinary Innovation Team will develop strategies and interventions to respond to the challenges posed by CO using a user-centered design approach.
- Rapid-test intervention prototypes. We will test selected strategies (prototypes) in Mexico, and South Africa with assessments to determine successes, and the feasibility of scaling up these approaches.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO intervention | Experimental | Behavioral: CO InterventionSouth Africa: All health facility staff working in facilities assigned to the intervention arm receive standard Ipas support (including monitoring of abortion service provision and support to Ipas-trained abortion providers) plus the CO intervention. Mexico: Doctors/anyone eligible to be an abortion provider working in facilities assigned to the intervention arm receive the CO intervention. |
| Control | No intervention | –South Africa: All health facility staff working in facilities assigned to the control arm receive standard Ipas support (including monitoring of abortion service provision and support to Ipas-trained abortion providers). Mexico: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All staff currently working in selected health facilities
- Able to provide informed consent
- Doctors/anyone eligible to be an abortion provider working in selected health facilities
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Mexico
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO InterventionSouth Africa: Values clarification and attitude transformation (VCAT) workshop with conscientious objection content, debrief session(s) with termination of pregnancy (TOP) providers to give them an opportunity to share concerns/challenges, meeting(s) with facility mangers to facilitate continued support and provision of TOP care Mexico: Training on abortion and conscientious objection law, posters on law, offer of legal assistance for abortion providers, scholarship to attend conference awarded on basis of quality of abortion care | Behavioural | CO intervention |
Primary outcome
Behavior making it easier for women to access abortion care
Time frame: Past 30 days
Proportion of health facility staff exhibiting at least one behavior to make it easier for women to access abortion care (e.g. helped a woman find the abortion care unit, provided positive support to a woman seeking abortion care, gave accurate information to a woman seeking abortion care, etc.).
Behavior making it more difficult for women to access abortion care
Time frame: Past 30 days
Proportion of health facility staff exhibiting at least one behavior to make it more difficult for women to access abortion care (e.g. gave incorrect directions to a woman seeking abortion care, told a woman abortion services were not available at the facility, tried to convince a woman that she should not have an abortion, etc.).
Intention to provide abortion service, referral, or information
Time frame: Next few days
Proportion of health facility staff reporting they would provide abortion service, referral or information to women seeking abortion care in their health unit in the next few days if needed.
2 secondary outcomes
Interest in attending an abortion care training
Time frame: Assessed at baseline and at 30-day follow-up
Stigmatizing Attitudes Beliefs and Actions Scale (SABAS) score
Time frame: Assessed at baseline and at 30-day follow-up
Results and safety
The study was stopped early (reason given: The study was stopped prematurely due to the COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 37396569Jim A, Magwentshu M, Menzel J, Kung SA, August SA, van Rooyen J, Chingwende R, Pearson E. Stigma towards women requesting abortion and association with health facility staff facilitation and obstruction of abortion care in South Africa. Front Glob Womens Health. 2023 Jun 15;4:1142638. doi: 10.3389/fgwh.2023.1142638. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Pearson, PhD, MPH principal investigator
Ipas
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO Intervention in people with Abortion, Induced and Abortion, Incomplete, run by Ipas at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped prematurely due to the COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior making it easier for women to access abortion care (time frame: Past 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04290832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.