Clinical trial NCT04290832: Developing and Testing Interventions to Address Conscientious Objection to Abortion Care in Mexico and South Africa
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abortion, Induced
Abortion, Incomplete
Lead sponsor: Ipas
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 317
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Behavior making it easier for women to access abortion care
timeFrame: Past 30 days
measure: Behavior making it more difficult for women to access abortion care
timeFrame: Past 30 days
measure: Intention to provide abortion service, referral, or information
timeFrame: Next few days
Secondary outcomes:
measure: Interest in attending an abortion care training
timeFrame: Assessed at baseline and at 30-day follow-up
measure: Stigmatizing Attitudes Beliefs and Actions Scale (SABAS) score
timeFrame: Assessed at baseline and at 30-day follow-up
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Ipas Central America and Mexico
city: Johannesburg
country: South Africa
facility: Ipas South Africa
Study officials:
affiliation: Ipas
name: Erin Pearson, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: