Evaluation of Values Clarification and Attitude Transformation Workshops on Abortion and Family Planning Service Provision and Client Experience

NCT ID: NCT04181021

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2021-01-26

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.

Detailed Description

This two-arm, parallel design stratified cluster randomized control trial aims to assess how Values Clarification and Attitude Transformation (VCAT) workshops on influences service provision to clients seeking abortion and family planning services. The study aims to assess whether the experiences and quality of care of abortion clients of any age and family planning clients under the age of 20 change as a potential consequence of the VCAT workshop. A secondary aim is to measure how provider attitudes, knowledge, and behavioral intent change over time in relation to the VCAT workshops. This study will be conducted at socially franchised facilities in the Blue Star network in Ethiopia run by Marie Stopes Ethiopia. This study is a mixed methods study with two concurrent quantitative study designs that account for the need for different recruitment and data collection strategies for the two target populations, clients and providers, and a qualitative component for both target populations.

The unit of randomization is the facility. Facilities will be randomized with a 1:1 ratio between intervention and control within strata defined by eligible client volume, using a disproportionate allocation by client volume. Facilities will not be blinded to treatment assignment group after baseline. To measure client experience of person-centered quality care, cross-sectional surveys with adolescent clients under 20 years old who receive family planning or abortion services, and with abortion clients of any age will be collected at two time points (before and after VCAT workshops). Clients will only be recruited from "high" volume facilities. Providers and promoters will be followed longitudinally for up to 6 months. A subsample of abortion clients who participated in the survey will be interviewed. Using preliminary analysis of provider responses, semi-structured in-depth interviews (IDI) with a subset of providers who took part in the VCAT training will be conducted. Providers from facilities who demonstrated significant change in outcomes of interest and those who did not will be purposively sample.

Additionally, service volume and referrals of abortion and family planning clients will be analyzed for all facilities using routine service statistics to assess whether there was a potential change in volumes related to the VCAT workshops.

Conditions

Abortion; Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Values Clarification and Attitudes Transformation (VCAT) Workshop

Intervention Type: BEHAVIORAL

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Values Clarification and Attitudes Transformation (VCAT) Workshop

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Marie Stopes International

OTHER

Sponsor Role: collaborator

Marie Stopes Ethiopia

UNKNOWN

Sponsor Role: collaborator

Ibis Reproductive Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra Wollum

Role: PRINCIPAL_INVESTIGATOR

Ibis Reproductive Health

Locations

Blue Star facilities

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

Countries

Ethiopia

References

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.

Reference Type: DERIVED

PMID: 39984306 (View on PubMed)

Other Identifiers

2019VCAT

Identifier Type: -

Identifier Source: org_study_id