An interventional study of CO Intervention in Abortion, Induced and Abortion, Incomplete, sponsored by Ipas. Terminated at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2020-07-29.
Sponsored by Ipas · Not applicable, Interventional, and Supportive care
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.
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:
24 studies on the registry are indexed under Abortion, Incomplete; 5 are open to participants now.
This study's enrollment of 317 is close to the median of 311 across 21 interventional studies indexed under Abortion, Incomplete.
Browse Abortion, Incomplete studies →Ipas is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
South Africa
Inclusion Criteria:
Exclusion Criteria:
Mexico
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: CO 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
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
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.).
Time frame: 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.).
Time frame: 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.
Time frame: Next few days
Interest in attending an abortion care training
Proportion of providers (doctors, nurses, or midwives) reporting being interested 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
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).
Time frame: Assessed at baseline and at 30-day follow-up
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2020 to primary completion in Mar 2020, 1 month.
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This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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