Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001228774
Ethics application status
Approved
Date submitted
24/08/2022
Date registered
12/09/2022
Date last updated
12/09/2022
Date data sharing statement initially provided
12/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Burkina Faso Protocol to Conduct Implementation Research on Introducing and Scaling Up Self-Administered Depo-Medroxyprogesterone acetate within Health Systems
Scientific title
Burkina Faso Protocol to Conduct Implementation Research on Introducing and Scaling Up Self-Administered Depo-Medroxyprogesterone acetate within Health Systems
Secondary ID [1] 307783 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraception 327364 0
Reproductive health. 327371 0
Condition category
Condition code
Reproductive Health and Childbirth 324488 324488 0 0
Contraception
Public Health 324633 324633 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implementation steps: The intervention will be directed by the Ministry of Health (MOH) and carried out by a team representing all levels of the district health system in Garango health district between September 2022 and August 2023. Implementation will transpire according to five steps.

Step 1: The Garango District Health Management Team (DHMT) will carry out a baseline needs assessment at all levels of care that were involved in the trainings that had been used in the district to introduce Subcutaneous Depomedroxyprogesterone Acetate (DMPA-SC) self-administration, with a focus on the CSPS-level, to obtain practical knowledge of how to maximize effective coverage of the FP service in Garango district. DHMT members will conduct the needs assessment themselves, or they will ask lower-level staff members of their staff at the district-level to complete data collection tasks on their behalf. The activities they will implement for the needs assessment will be the same as the activities they routinely use to prepare for new initiatives be it research related or simply programmatic (e.g., review related desk review documents, convene one-on-one and group meetings to obtain insights and strategic information from health care workers and other staff of the district, and then make decisions on what to do). Interviews with care providers will last between 30-45 minutes and interviewers will follow a topic guide. Interviews will mostly be conducted by staff persons of DHMT members. DHMT members will facilitate group meetings with 6-8 health facility managers and may also use a topic guide to structure this discussion if necessary. These meetings will last between 60 and 90 minutes. The DHMT will use this information they obtain during the needs assessment to develop a Quality Improvement Collaborative (QIC) charter that articulates the specific objectives and activities that DHMT and health system stakeholders in Garango will follow to improve how DMPA-SC self-administration is made available, and to improve efforts to generate demand for the method. This will also include the appointment of actors – i.e., DHMT members and their staff, health workers from health centers and primary health care facilities, community health workers, staff from pharmacies where DMPA-SC is available – to take responsibility for specific activities,

Step 2: Actors appointed in step 1 will work toward operationalizing the QIC charter into a feasible action plan that can be carried out with the resources and structures in place in Garango (November - December 2022). As stated above, ‘actors’ refers to DHMT members and their staff, health workers from health centers and primary health care facilities, community health workers, and staff from pharmacies where DMPA-SC is available. Different groups of actors will be assigned to different activities of the QIC charter. Members of the respective groups will work together to operationalize their activities into a concrete series of steps they will follow to implement each QIC activity. To ‘operationalize’ these activities, each group will convene a meeting (or multiple meetings) to agree on a vision for what their respective QIC activities will be, and proceed to collaboratively break down the activity into a sequence of steps (i.e., an action plan). Activities that involve the community will involve community stakeholders, such as community health workers. Groups will be permitted to conduct their group meetings and discussions as they wish, but they will be asked to require that participants take tuns speaking, actively listen when not speaking and that a group member takes notes. These notes will be collected by a member of the study team and archived safely so that there is documentation of QIC charter implementation processes. Step 2 deliberations and action planning will take place within 1 month of completion of the Step 1 needs assessment.

Step 3 and 4: During step 3, the QIC members will launch the implementation of the action plans they developed in step 2. Step 3 will commence within 1 month of completing of the discussions and action planning in step 2. Launch of the action plans that will occur in step 3 will include cascade trainings on DMPA-SC self-administration and other capacity building activities that are tailored to the needs of QIC teams that, at this time, will enact their plans to expand the reach throughout communities of knowledge of the method and opportunities to uptake and continue self-injection (January to June 2023). Step 3 will take place in the first three months (Jan-Mar 2023) and include onsite trainings and frequent engagement between trainers appointed by the DHMT (in the QIC) and facilities’ staff. Step 4 will take place in the last three months (Apr-Jun 2023) and comprise of periodic supervision visits in which the DHMT appointed trainers visit their trainees onsite approximately once per month.

The groups assigned responsibility for trainings will have the opportunity to adapt existing regimens and materials to meet their needs and detail on this will be available after step 2. However, now we can provide information on the anticipated format, content and frequency of activities. Trainings will consist of small group discussions and demonstrations, mostly taking place at facilities while trainees are ‘on the job’. Information and knowledge traditionally imparted in lectures will be packaged into modules that trainers will impart during these sessions. Sessions will consist of a trainer and 4-5 trainees. Trainees will be staff of primary health care facilities and the community health workers that report to them. Whereas there will be some emphasis on didactic learning, trainings will focus on competencies and emphasize practical skill development. Since providers are already authorized to deliver contraception to clients, during training sessions they will be coached on ways to improve their performance not only with respect to method provision, but also counseling, infection prevention and control, ascertaining clients’ underlying fertility intentions or concerns and advising them on alternative contraceptive methods, if appropriate, as well as referral for other reproductive health care services. The frequency of trainings will be concentrated in the beginning of the 6-month period allocated for this activity. We anticipate that trainers will spend 2 hours at each primary health care site every other week for the first 3 months of this step and then 1 visit to each site per month for the last 3-months of this step. Follow up visits during the final 3-months of this step will last, on average, 1 hour. The stakeholders responsible for the trainings will have the opportunity to adapt existing training materials, if necessary, or use existing training materials without adaptation if they prefer. These materials include worksheets based on the curricula, checklists, job aids (for distribution to health care workers), informational leaflets (for distribution to clients). Other capacity building activities may include partnering facility staff that are new to initiating clients to self-administration of DMPA-SC with staff members that are more experienced, and building skills of the latter to coach and mentor their less experienced peer. Similarly, as these trainings progress, district staff may observe that some facilities are performing better than others, and based on this, they may coordinate peer-exchanges between facility teams. Peer exchanges would emphasize the more strongly performing team imparting lessons and coaching peers from the facility that is not performing as well.

The purpose of this step is to strengthen the district’s training processes to help ensure that skill building and demand generation opportunities reach the lowest level of the district health system, where women that desire DMPA-SC for self-injection are mostly likely to come for the method. Given the competency-based, on the job nature of the trainings, and they fact that all facility-based health care workers engaged in trainings are already allowed by national policy to deliver the method to women, during this step health care workers will also train women in self-injection. In doing so they will follow all existing policy and clinical guidelines related to this intervention. This will include training clients to self-inject, directly observing the client self-administer one dose, and then prescribing two additional doses for the women to take with her as she leaves the facility (to take 90 and 180 days later). Health care workers will use any existing, government approved measures to monitor clients adherence to the method. These include home visits from a community health worker (if the client agrees to receive a home visit at the time she initiates self-injection at the primary health care facility). In addition, clients will be instructed to return to the facility after self-administering their second and third doses and bringing with them a plastic container contains used syringes (plastic containers are dispensed to women when they are initiated to self-administration at the health facility).

Step 5: During step 5, QIC members will reconvene and review the experience of action plan implementation and adaptation for the previous 6-months, deliberate on lessons learned and recommendations for future programming and scale up in Burkina Faso (July to August 2023). It is anticipated that the review process will comprise of 2 workshops, each approximately 2-hours in duration, to review barriers and facilities to effective action plan implementation. Detailed reports containing lessons learned and recommendations will be written up by the DHMT staff with assistance from members of the research team. These reports will be made available in electronic format to stakeholders from other districts in Burkina Faso and the Ministry of Health.
Intervention code [1] 324248 0
Behaviour
Comparator / control treatment
The above-described intervention will be conducted in Garango district of Burkina Faso. Outcomes of the intervention will be compared with the same measures obtained from Tenkodogo district, where the MOH and district teams will implement their usual training and demand generation activities. Usual trainings typically didactic and comprise of lectures containing theoretical content and information about DMPA-SC self-administration, the government's policy on eligibility criteria and what workers are allowed to initiate women to the practice. Usual trainings do not contain opportunities for learners at the primary care level to obtain practical experience with the intervention (e.g., competency-based sessions where trainees learn a skill by doing it). T0 date, we are not aware of any concerted strategy to generate demand for self-administered DMPA-SC per se; however, in districts where self-administered DMPA-SC is available, district staff informed community-based health care workers of the new method and community-based health care workers had the opportunity to educate communities about the intervention if they chose to.
Control group
Active

Outcomes
Primary outcome [1] 332312 0
Changes in eligible contraceptive users' knowledge of self-administration of DMPA-SC as a family planning method and how to access the method. To assess this, the research team will design and conduct household surveys that enroll eligible family planning users before and after the intervention.
Timepoint [1] 332312 0
Baseline (September 2022) and endline (August 2023, 11 months post-intervention commencement).
Primary outcome [2] 332313 0
Changes in the proportion of injectable contraceptive users that voluntarily use self-administration of DMPA-SC. This will be assessed by way of routine prospective extraction of data from service delivery registers located at facilities where clients are initiated to self-administration and given supplies.
Timepoint [2] 332313 0
Routine prospective extraction of data will take place at facilities in both study arms will take place every other month from intervention commencement in September 2022 until August 2023.
Secondary outcome [1] 412990 0
The costs of implementing the intervention per quality adjusted life year gained by introducing self-administered DMPA-SC into the contraceptive method mix comparing implementation across the two study arms. This will be assessed by auditing records which contain information on service delivery inputs and directly observing health worker time use related to the intervention. Records will be made available to data collectors at health facility and district health management offices.
Timepoint [1] 412990 0
Routine prospective monitoring of implementation costs and family planning service utilization throughout the trial will take place every other month from intervention commencement in September 2022 until August 2023.
Secondary outcome [2] 413013 0
The feasibility of adapting and implementing the strategy that will be delivered in the intervention arm. This will be assessed by a composite of: (1) use of quantitative checklist for the routine prospective monitoring of action plan implementation and (2) qualitative appraisals of implementer experiences, reactions and attitudes toward the intervention (in-depth interviews and focus group discussions).
Timepoint [2] 413013 0
Use of quantitative checklist for the routine prospective monitoring of action plan implementation will occur once every other month from intervention commencement in September 2022, until August 2023. Qualitative appraisals of implementer experiences, reactions and attitudes toward the intervention (in-depth interviews and focus group discussions will take place in November-December 2022 (3-4 months post-intervention commencement) and July and August 2023 (10-11 months post-intervention commencement).

Eligibility
Key inclusion criteria
Human subjects comprise of (1) health care facility and district management staff in Garango district, where the intervention will be conducted, and (2) Eligible contraceptive users residing in households in Garango and Tenkodogo districts (intervention and comparison districts).

Health care workers and management staff may be included in primary data collection if they are involved in conducting or supervising the implementation of the intervention in Garango district. Women may be included in primary data collection if they are eligible to use modern contraceptive methods because they are between ages 15-49, and reside within the catchment area of sites where self-administered DMPA-SC has been introduced.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Health care workers and management staff will be excluded if they indicate their individual involvement in the intervention is so insufficient that they cannot credibly provide information on the intervention.

Women will be excluded if they were not resident in their current households for more than 6 months or if they are not eligible to use modern contraception (not of reproductive age).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2022
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
6690
Accrual to date
Final
Recruitment outside Australia
Country [1] 24958 0
Burkina Faso
State/province [1] 24958 0
Garango district, Tenkodogo district

Funding & Sponsors
Funding source category [1] 312056 0
Other
Name [1] 312056 0
Human Reproduction Program, World Health Organization
Country [1] 312056 0
Switzerland
Primary sponsor type
Other
Name
Human Reproduction Program, World Health Organization
Address
20 Avenue Appia, Geneva, Switzerland 1208.
Country
Switzerland
Secondary sponsor category [1] 313629 0
None
Name [1] 313629 0
Address [1] 313629 0
Country [1] 313629 0
Other collaborator category [1] 282406 0
Government body
Name [1] 282406 0
Institute for Health Sciences Research
Address [1] 282406 0
03 BP 7192, Wemtenga, Ouagadougou, 03 Burkina Faso,

(postal code is 03)
Country [1] 282406 0
Burkina Faso
Other collaborator category [2] 282415 0
University
Name [2] 282415 0
Department of Global Health, University of Washington
Address [2] 282415 0
Hans Rosling Center
3980 15th Ave NE
Seattle, WA 98105
Country [2] 282415 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311466 0
World Health Organization Ethical Review Committee
Ethics committee address [1] 311466 0
Ethics committee country [1] 311466 0
Switzerland
Date submitted for ethics approval [1] 311466 0
Approval date [1] 311466 0
02/12/2021
Ethics approval number [1] 311466 0
A66003 Burkina Faso 005391
Ethics committee name [2] 311471 0
Ethics Committee for Health Research, Ministry of Health Burkina Faso
Ethics committee address [2] 311471 0
Ethics committee country [2] 311471 0
Burkina Faso
Date submitted for ethics approval [2] 311471 0
Approval date [2] 311471 0
01/12/2021
Ethics approval number [2] 311471 0
2021-12-272

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121194 0
Prof Seni Kouanda
Address 121194 0
Institute for Health Science Research
03 B.P. 7192 Ouagadougou 03 Burkina Faso
Country 121194 0
Burkina Faso
Phone 121194 0
+226 25 36 32 15
Fax 121194 0
Email 121194 0
[email protected]
Contact person for public queries
Name 121195 0
Petrus Steyn
Address 121195 0
The World Health Organization
20 Avenue Appia, Geneva, Switzerland 1208.
Country 121195 0
Switzerland
Phone 121195 0
+41 22 791 21 11
Fax 121195 0
Email 121195 0
[email protected]
Contact person for scientific queries
Name 121196 0
Petrus Steyn
Address 121196 0
The World Health Organization
20 Avenue Appia, Geneva, Switzerland 1208.
Country 121196 0
Switzerland
Phone 121196 0
+41 22 791 21 11
Fax 121196 0
Email 121196 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual level data as agreed by the primary sponsor and the principal investigator of each country in the data transfer agreement.
When will data be available (start and end dates)?
De-identified country specific data will be available1 year after primary manuscript has been published as agreed on the Data Transfer Agreement. De-identified country specific data will be available for10 years after that.
Available to whom?
Request for de-identified data may be submitted to Principal Investigators, and data will be shared contingent on approval by the internal review and approval by local internal ethics review board.
Available for what types of analyses?
Non-specific but relevant to proposals approved internally and by local ethics review.
How or where can data be obtained?
Please email Dr. Petrus Steyn at [email protected].


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.