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AbortionNCT04181021

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

A study testing Values Clarification and Attitudes Transformation (VCAT) Workshop in people with Abortion and Contraception, run by Ibis Reproductive Health at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Abortion, Contraception
What is being tested?
Values Clarification and Attitudes Transformation (VCAT) Workshop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
1 siteEthiopia
Study dates
25 Nov 2019to 26 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site

  • Blue Star facilities

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

Other trials in Ethiopia

About this study

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

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.

Read the 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.

Being tested
Values Clarification and Attitudes Transformation (VCAT) Workshop

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Values Clarification and Attitudes Transformation (VCAT) WorkshopBehavioural

    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.

Study groups in NCT04181021
Study groupRoleWhat they receive
InterventionExperimentalProviders 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.
Receives: Behavioral: Values Clarification and Attitudes Transformation (VCAT) Workshop
ControlNo interventionProviders and promoters in the control arm will not be invited to participate in the VCAT workshop.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1.5 months

  2. 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

    Measured: 1.5 months

Secondary outcomes (5)

  1. 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

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. Volume of patients

    Volume of abortion and family planning clients under age 20

    Measured: 1 year

  4. Patient referrals by promoters

    Number of referrals for safe abortion care and for family planning among clients under the age of 20

    Measured: 1 year

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

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2019
  2. Study start25 Nov 2019
  3. Primary completion26 Jan 2021
  4. Study completion26 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04181021
Sponsor's protocol ID
2019VCAT
Status last verified
Aug 2021
First submitted
26 Nov 2019
Last updated
27 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39984306

Questions about this trial

What is this clinical trial studying?

A study testing Values Clarification and Attitudes Transformation (VCAT) Workshop in people with Abortion and Contraception, run by Ibis Reproductive Health at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Person-centered abortion and family planning scale (time frame: 1.5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04181021, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.

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