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

Contraception Clinical Trial

Official title:

Evaluation of Values Clarification and Attitude Transformation Workshops on Abortion and Family Planning Service Provision and Client Experience in Socially Franchised Facilities in Ethiopia: A Cluster Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04181021
• Other study ID #: 2019VCAT
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: January 26, 2021

Study information

• Verified date: August 2021
• Source: Ibis Reproductive Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: January 26, 2021
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion
• Contraception

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Ethiopia	Blue Star facilities	Multiple	Addis Ababa, Oromiya, Tigray, Snnpr, Amhara

Sponsors (3)

Lead Sponsor	Collaborator
Ibis Reproductive Health	Marie Stopes Ethiopia, Marie Stopes International

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Agreement with the following four measures that capture agreement with providing abortion and family planning even in cases where providers may have conflicted values: I feel comfortable performing a safe abortion procedure for anyone who requests it regardless of the reason,I support a client's decision to have a safe abortion even if I didn't agree with her decision, I could provide family planning to a client even if I thought they were too young to be using contraception, I feel comfortable removing IUDs or implants even if I think the client shouldn't have it removed	6 months
Secondary	Level of knowledge around interpretation for legal grounds for abortion in Ethiopia	Proportion knowing the legal indications for abortion in Ethiopia, the legal grounds for denial of abortion services, and the correct interpretation of the law around abortion services for married women, minors, women seeking services under the rape and incest clause, and women requesting an abortion under the grounds that the pregnancy is a risk to their health	6 months
Secondary	Volume of patients	Volume of abortion and family planning clients under age 20	1 year
Secondary	Patient referrals by promoters	Number of referrals for safe abortion care and for family planning among clients under the age of 20	1 year
Secondary	Percent of providers who believe that women should have access to safe, comprehensive abortion care regardless of COVID-19 in Ethiopia		9 months