NCT04290832

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

February 27, 2020

Last Update Submit

July 27, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Interest in attending an abortion care training

    Assessed at baseline and at 30-day follow-up

  • Stigmatizing Attitudes Beliefs and Actions Scale (SABAS) score

    Assessed at baseline and at 30-day follow-up

Study Arms (2)

CO intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

CO InterventionBEHAVIORAL

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

CO intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ipas Central America and Mexico

Mexico City, Mexico

Location

Ipas South Africa

Johannesburg, South Africa

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Abortion, Incomplete

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Erin Pearson, PhD, MPH

    Ipas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 2, 2020

Study Start

February 13, 2020

Primary Completion

March 17, 2020

Study Completion

June 30, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations