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

NCT ID: NCT04290832

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-13

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Abortion, Induced Abortion, Incomplete

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CO Intervention

Intervention Type BEHAVIORAL

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


* 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

Mexico


* Unable to provide informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ipas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Pearson, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ipas

Locations

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Ipas Central America and Mexico

Mexico City, , Mexico

Site Status

Ipas South Africa

Johannesburg, , South Africa

Site Status

Countries

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Mexico South Africa

References

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Jim A, Magwentshu M, Menzel J, Kung SA, August SA, van Rooyen J, Chingwende R, Pearson E. Stigma towards women requesting abortion and association with health facility staff facilitation and obstruction of abortion care in South Africa. Front Glob Womens Health. 2023 Jun 15;4:1142638. doi: 10.3389/fgwh.2023.1142638. eCollection 2023.

Reference Type DERIVED
PMID: 37396569 (View on PubMed)

Other Identifiers

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TIE_2020_01

Identifier Type: -

Identifier Source: org_study_id

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