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

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.

Study Overview

• Status: Terminated
• Conditions: Abortion, Induced; Abortion, Incomplete
• Intervention / Treatment: Behavioral: CO Intervention

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 Type: Interventional
• Enrollment (Actual): 317
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Ipas Central America and Mexico
• South Africa
  • Johannesburg, South Africa
    • Ipas South Africa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

South Africa

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: CO 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
NO_INTERVENTION: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.).	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.).	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.	Next few days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interest in attending an abortion care training	Proportion of providers (doctors, nurses, or midwives) reporting being interested in attending an abortion care training.	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).	Assessed at baseline and at 30-day follow-up

Collaborators and Investigators

• Sponsor: Ipas
• Investigators: Principal Investigator: Erin Pearson, PhD, MPH, Ipas

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 13, 2020
• Primary Completion (ACTUAL): March 17, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (ACTUAL): March 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Incomplete
• Other Study ID Numbers: TIE_2020_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No