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

Abortion, Induced Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04290832
• Other study ID #: TIE_2020_01
• Status: Terminated
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Ipas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 317
• Est. completion date: June 30, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Incomplete
• Abortion, Induced

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

Locations

Country	Name	City	State
Mexico	Ipas Central America and Mexico	Mexico City
South Africa	Ipas South Africa	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
Ipas

Countries where clinical trial is conducted

Mexico,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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