NCT04181021

Brief Summary

Stigma around abortion and other reproductive health care is pervasive in most contexts and has been documented to have implications for the quality of care. This study aims to assess how Values Clarification and Attitude Transformation (VCAT) workshops for providers of abortion and family planning services influences service provision of abortion and family planning services, including the quality and person-centeredness of care provided. A secondary aim is to measure how provider attitudes, knowledge, and behavioral intent change over time as a result of the VCAT workshop.This study will be conducted across multiple regions in Ethiopia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

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

November 25, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

November 26, 2019

Last Update Submit

August 23, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Person-centered abortion and family planning scale

    A validated scale measuring the dimensions of respectful and supportive care, communication and autonomy, and structural quality. The score is on a scale from 0 to 69 and higher scores represent more person-centered care.

    1.5 months

  • Percent of clients reporting essential person-centered care components

    Percent of clients reporting having received kind and compassionate care from their provider, not feeling like they were treated differently based on age, marital status, or other characteristic, not feeling judged by their provider, having received respectful care, and feeling involved in the decisions around their care

    1.5 months

Secondary Outcomes (5)

  • Percent of providers that agree they could support a woman having an abortion or using family planning if they didn't agree with their decision

    6 months

  • Level of knowledge around interpretation for legal grounds for abortion in Ethiopia

    6 months

  • Volume of patients

    1 year

  • Patient referrals by promoters

    1 year

  • Percent of providers who believe that women should have access to safe, comprehensive abortion care regardless of COVID-19 in Ethiopia

    9 months

Study Arms (2)

Intervention

EXPERIMENTAL

Providers and community-based promoters will participate in the VCAT workshop. Providers and community-based promoters will take part in two different workshops at different times.

Behavioral: Values Clarification and Attitudes Transformation (VCAT) Workshop

Control

NO INTERVENTION

Providers and promoters in the control arm will not be invited to participate in the VCAT workshop.

Interventions

VCAT is a participatory workshop aimed to provide accurate information about abortion and family planning and space to engage in critical self-reflection, provoke dialogue on beliefs, values and professional ethics and responsibilities around providing abortion and contraceptive care, and provide a deeper understanding of the range of circumstances in which women seek abortion and contraception.

Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Eligibility Criteria for clients: * Be willing to participate * Speak a language that is spoken by a study staff member * Be able to give informed consent * Have obtained abortion services (any age) or family planning services (\<20 years old) from one of the participating social franchise facilities during one of the study periods Eligibility Criteria for providers: * Be trained to provide medication abortion and/or surgical abortion or be a community-based promoter employed by participating Blue Star facilities * Speak one of the study languages, including English, Amharic, Oromiffa, and Tigrinya. * Be willing to be randomized to either participate in VCAT training or be in the control arm. * Be willing to participate in the study * Be able to provide informed consent * Have a private space in the clinic for clients to complete the client survey and in-depth interview * Not have participated in 2018 pilot VCAT trainings * Work at a facility that has been a part of the social franchise network for at least six months prior to the study Eligibility criteria for promoters * Speak a language spoken by a study staff member * Be willing to participate in the study * Be willing to be randomized to participate in the VCAT training for community-based promoters

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Blue Star facilities

Multiple, Addis Ababa, Oromiya, Tigray, Snnpr, Amhara, Ethiopia

Location

Related Publications (1)

  • Wollum A, Key K, Mersha T, Nicholson M, Page G, Austen K, Endale ME, Moseson H. Does a values clarification and attitudes transformation (VCAT) workshop influence provider attitudes, knowledge, and service provision related to abortion care?: Evidence from a mixed-methods longitudinal randomised controlled trial in Ethiopia. Glob Public Health. 2025 Dec;20(1):2465643. doi: 10.1080/17441692.2025.2465643. Epub 2025 Feb 21.

Study Officials

  • Alexandra Wollum

    Ibis Reproductive Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2019

First Posted

November 29, 2019

Study Start

November 25, 2019

Primary Completion

January 26, 2021

Study Completion

January 26, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations