Developing and Testing Interventions to Address Conscientious Objection to Abortion Care in Mexico and South Africa

Not Applicable

Terminated

• Conditions: Abortion, Induced; Abortion, Incomplete
• Interventions: Behavioral: CO Intervention

• Registration Number: NCT04290832
• Lead Sponsor: Ipas

Brief 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.

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:

1. 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.

2. 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.

3. 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 Timeline

• Study Start: 2020-02-13
• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Primary Completion: 2020-03-17
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

• All staff currently working in selected health facilities
• Able to provide informed consent

Exclusion Criteria

• Unable to provide informed consent

Mexico

Inclusion Criteria:

• Doctors/anyone eligible to be an abortion provider working in selected health facilities
• Able to provide informed consent

Exclusion Criteria:

• Unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CO intervention	CO Intervention	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.

Primary Outcome Measures

Name	Time	Method
Intention to provide abortion service, referral, or information	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.
Behavior making it easier for women to access abortion care	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	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.).

Secondary Outcome Measures

Name	Time	Method
Stigmatizing Attitudes Beliefs and Actions Scale (SABAS) score	Assessed at baseline and at 30-day follow-up	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).
Interest in attending an abortion care training	Assessed at baseline and at 30-day follow-up	Proportion of providers (doctors, nurses, or midwives) reporting being interested in attending an abortion care training.

Trial Locations

Locations (2)

Ipas Central America and Mexico; 🇲🇽 Mexico City, Mexico

Ipas South Africa; 🇿🇦 Johannesburg, South Africa