Clinical trial NCT04181021: Evaluation of Values Clarification and Attitude Transformation Workshops on Abortion and Family Planning Service Provision and Client Experience
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion
Contraception
Lead sponsor: Ibis Reproductive Health
Sponsor class: OTHER
Collaborators: name: Marie Stopes International
name: Marie Stopes Ethiopia
First posted: 2019-11-29
Enrollment: 217
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Person-centered abortion and family planning scale
timeFrame: 1.5 months
measure: Percent of clients reporting essential person-centered care components
timeFrame: 1.5 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: Level of knowledge around interpretation for legal grounds for abortion in Ethiopia
timeFrame: 6 months
measure: Volume of patients
timeFrame: 1 year
measure: Patient referrals by promoters
timeFrame: 1 year
measure: Percent of providers who believe that women should have access to safe, comprehensive abortion care regardless of COVID-19 in Ethiopia
timeFrame: 9 months
Other outcomes:
Locations:
city: Multiple
country: Ethiopia
facility: Blue Star facilities
state: Addis Ababa, Oromiya, Tigray, Snnpr, Amhara
Study officials:
affiliation: Ibis Reproductive Health
name: Alexandra Wollum
role: PRINCIPAL_INVESTIGATOR
References: