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Trial registered on ANZCTR


Registration number
ACTRN12619000378123
Ethics application status
Approved
Date submitted
25/01/2019
Date registered
11/03/2019
Date last updated
10/06/2021
Date data sharing statement initially provided
11/03/2019
Date results information initially provided
11/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Community and Provider Driven Social Accountability Intervention (CaPSAI) Project: a study to evaluate how social accountability processes in family planning programs influence quality of care and client satisfaction and whether this results in increased contraceptive uptake and use
Scientific title
Quasi-experimental pretest-post-test study to determine the number of new users of contraception amongst women 15-49 years old before and after introduction of a community and provider driven social accountability intervention.
Secondary ID [1] 297166 0
WHO ERC: A65896
Universal Trial Number (UTN)
U1111-1227-6131
Trial acronym
CaPSAI Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraceptive uptake 311199 0
Contraceptive use 311200 0
Condition category
Condition code
Public Health 309818 309818 0 0
Health promotion/education
Reproductive Health and Childbirth 309819 309819 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CaPSAI Project scales up existing Community and Provider driven Social Accountability Intervention where services users and providers assess the quality of local health services and jointly identify ways to improve the delivery and quality of such services, applying it to a family planning/contraceptive programme. Ghana and Tanzania were selected as the intervention countries based on a set of selection criteria that include: existence of a national civil society organisation (CSO) partner with local experience of delivering a social accountability intervention with the eight standard steps, low modern contraceptive prevalence rate, availability of family planning services at the point of contact by the client at no cost or where cost is not a barrier to access, an enabling environment in terms of the potential for the health system to respond to the social accountability activities, and the existence of formal structures linking the community with the health system (e.g. health committees). Ghana Integrity Initiate in Ghana and Sikika in Tanzania have previous experience implementing social accountability interventions that have the eight standard steps of the CaPSAI. The eight standard steps were distilled from community scorecards, citizen voice and accountability projects and citizen hearings which have been implemented and evaluated by other organisations as well as the formative phase of the UPTAKE and Evidence Projects. Details regarding the eight steps and the activities under each step, including communications activities and materials used are described below:

Step 1. Introduction of the intervention to the community: The implementation partner (a civil society organization) meets with local leaders, identifies stakeholders and sets up the infrastructure to deliver the intervention.
Step 2. Mobilization of participants for the intervention: Community members, service providers and other duty bearers are gathered by the implementing partner and introduced to the intervention. Community public address system will be used to mobilize participants to attend the community meetings. Flyers will be distributed to mobilize participation of stakeholders (individuals and organizations) to partake in the activities, and provide information about family planning.
Step 3. Health, rights and civic education with community participants: The implementation partner shares information on health awareness and education, existing service standards and provides training on rights, good governance and accountability. The group begins to rate existing services against rights-based standards and generate discussion about local priorities. Pull-up banners will be displayed in the meeting venues to explain objectives of specific meeting/event being conducted as well as upcoming events. Posters developed from existing client charter and guidelines will be displayed to educate community members on their rights, roles and responsibilities as users of family planning services.
Step 4. Prioritization meeting with community: The implementation partner distils themes and priorities raised by the community. The community groups then collectively score the issues and indicators and set priority areas for action. Pull-up banners will be displayed in the meeting venues to explain objectives of specific meeting/event being conducted as well as upcoming events.
Step 5. Prioritization meeting with duty bearers: The implementation partner distils themes and priorities raised by the service providers. The providers then collectively score the issues and indicators and set priority areas for action. Pull-up banners will be displayed in the meeting venues to explain objectives of specific meeting/event being conducted as well as upcoming events.
Step 6. Interface meeting and joint action planning: The implementation partner then holds a joint meeting between the community, the service providers and other duty bearers. Following the presentation of results from the prioritization meetings the community groups and the service providers will aim to reach consensus on the ranking of the priority items and the actions required to address them. An action plan with assigned roles and responsibilities will be developed for the following 6-12 month period. Pull-up banners will be displayed in the meeting venues to explain objectives of specific meeting/event being conducted as well as upcoming events. Posters with action plans resulting from the interface meetings will be produced for awareness promotion and for advocacy for inclusion in the planning and budgeting of the districts.
Step 7. First follow-up meeting with community and duty bearers at three months: Priority areas and action items will be followed up with both the community and service providers. It is at this stage that change is anticipated on the part of health care professionals and remedial actions have taken place which should be demonstrated in the monitoring activities. For any unresolved issues these meetings present an opportunity to involve higher level duty bearers or third party pressure groups (media/ politicians) to increase the pressure to act. Pull-up banners will be displayed in the meeting venues to explain objectives of specific meeting/event being conducted as well as upcoming events
Step 8. Second follow-up meeting with community duty bearers at six months: A second follow-up meeting will enable the monitoring of longer range outcomes and on the remedy of unresolved issues raised in the first follow-up meeting. The community and service providers will continue to monitor the action plan for changes in relation to agreed priority areas.Pull-up banners will be displayed in the meeting venues to explain objectives of specific meeting/event being conducted as well as upcoming events

The intervention (one round of the eight steps) is conducted over the period of 12 months in selected districts in the catchment area of eight intervention facilities. A mapping of facilities in the selected districts was conducted to gather data on the demographic composition of the facility catchment areas, modern contraceptive rates and a number of new users (within past six months) and identify eligible facilities and match them. Data on facilities in the pre-selected districts, where there are no social accountability intervention in family planning currently taking place, were gathered. Eight intervention and eight control facilities were selected.

The implementing partners document their plans prior to implementation and write up post-implementation reports following completion of each step. The plans and reports are reviewed as part of the process evaluation: document review. The research partners also conduct process evaluation activities in four of the eight facilities in each country, such as non-participant observations and in-depth interviews to assess and monitor content fidelity across the two country contexts.
Intervention code [1] 313427 0
Behaviour
Comparator / control treatment
Eight control facilities were selected following a mapping of facilities conducted in the selected districts to gather data on the demographic composition of the facility catchment areas, modern contraceptive rates and a number of new users (within past six months). Considerations were put in place to ensure that the control and intervention facilities match and that contamination is minimized. Criteria such as facility type and level, average number of service users and number of new users, were used to match the study and control facilities.

Control facilities will continue with usual care of offering family planning services. As part of the process evaluation, a context mapping activity to capture context related information will be conducted in both intervention and control sites at the onset, mid and end of the study. The context mapping will consist of interviews with key stakeholders at the national and/or district level who are purposively and snowball sampled to ask about other social accountability and reproductive interventions which have taken place over the past three years before the intervention at baseline and subsequently at mid and end-line. Results of the mapping exercise, along with the findings from other research activities will only be shared to the control sites at the end of the study during the dissemination meetings where training on replicating the intervention will be provided.
Control group
Active

Outcomes
Primary outcome [1] 318779 0
Changes in contraceptive uptake: rate of first-time contraceptive use per facility per month. Number of new users and population data will be collected through facility audit in both intervention and control sites. The audit is completed by consulting staff member/s from the facility, that may include: Manager, Person in-charge of the facility and/or most senior health worker responsible for outpatient services who is present at the facility. Facility records will also be consulted to verify data on new users.
Timepoint [1] 318779 0
The audit will be conducted every 12 months during the study period to capture any changes at baseline, at mid-point (at 12 months) and at end-line (at 24 months). Monthly data on new users of contraceptives will be recorded starting from six months prior to baseline and every month until endline.
Primary outcome [2] 318780 0
As part of evaluating changes in contraceptive use: the method contraception discontinuation rate (first use) will be estimated using a prospective cohort study design. The outcome of interest is time from starting use of the modern contraceptive method use to when its use is discontinued. The discontinuation rate –being a time-to-event outcome and involving censoring– necessitates the use of sample size estimation methods for survival data. Data is collected using standardised interview questions across both intervention and control facilities.
Timepoint [2] 318780 0
A cohort of women new to using contraception in both intervention and control facilities over a 12-month period (starting at the end of the main intervention steps - end of step 6).
Secondary outcome [1] 366345 0
As part of evaluating changes in contraceptive use: contraceptive method continuation, which is the proportion of women in a cohort using the same contraceptive method after one year will be measured. Data is collected using standardised interview questions across both intervention and control facilities.
Timepoint [1] 366345 0
A cohort of women new to using contraception in both intervention and control facilities over a 12-month period (starting at the end of the main intervention steps - end of step 6).
Secondary outcome [2] 366346 0
As part of evaluating changes in contraceptive use: Contraceptive switching, which is the proportion of women in a cohort changing method within one year of initiation, out of those using any method at baseline/ proportion of women changing method because they were not satisfied with previous one will be measured. Data is collected using standardised interview questions across both intervention and control facilities.
Timepoint [2] 366346 0
A cohort of women new to using contraception in both intervention and control facilities over a 12-month period (starting at the end of the main intervention steps - end of step 6).
Secondary outcome [3] 366347 0
Changes in social accountability outcomes among service users: empowerment of women measured through a cross sectional survey using a questionnaire of accountability-related psychometric scales. The study uses the CARE Women’s VOICES tool to measure governance outcomes in sexual, reproductive and maternal health programs adapted to assess family planning programs (Health Workers’ (2014) Women’s VOICES: A Tool to Measure Governance Outcomes in Sexual, Reproductive & Maternal Health Programs. Copyright 2014 Cooperative for Assistance and Relief Everywhere, Inc. (CARE). Used by Permission.)

Timepoint [3] 366347 0
A cross sectional survey using a questionnaire of accountability-related psychometric scales will be conducted with service users at the facilities receiving the intervention at pre (before step 1 of the intervention) and post intervention (starting immediately after completion of step 8 and completed within three months.
Secondary outcome [4] 366348 0
Changes in social accountability outcomes among service users: expansion of negotiated spaces for women measured through a cross sectional survey using a questionnaire of accountability-related psychometric scales. The study uses the CARE Women’s VOICES tool to measure governance outcomes in sexual, reproductive and maternal health programs adapted to assess family planning programs (Health Workers’ (2014) Women’s VOICES: A Tool to Measure Governance Outcomes in Sexual, Reproductive & Maternal Health Programs. Copyright 2014 Cooperative for Assistance and Relief Everywhere, Inc. (CARE). Used by Permission.)
Timepoint [4] 366348 0
A cross sectional survey using a questionnaire of accountability-related psychometric scales will be conducted with service users at the facilities receiving the intervention at pre (before step 1 of the intervention) and post intervention (starting immediately after completion of step 8 and completed within three months.
Secondary outcome [5] 366349 0
Changes in social accountability outcomes among health providers: empowerment of health providers measured through a cross sectional survey using a questionnaire of accountability-related psychometric scales. The study uses the CARE Women’s VOICES tool to measure governance outcomes in sexual, reproductive and maternal health programs adapted to assess family planning programs (Health Workers’ (2014) Women’s VOICES: A Tool to Measure Governance Outcomes in Sexual, Reproductive & Maternal Health Programs. Copyright 2014 Cooperative for Assistance and Relief Everywhere, Inc. (CARE). Used by Permission.)
Timepoint [5] 366349 0
A cross sectional survey using a questionnaire of accountability-related psychometric scales will be conducted with health care providers at the facilities receiving the intervention at pre (before step 1 of the intervention) and post intervention (starting immediately after completion of step 8 and completed within three months.
Secondary outcome [6] 366350 0
Changes in social accountability outcomes among health providers: expansion of negotiated spaces for health providers measured through a cross sectional survey using a questionnaire of accountability-related psychometric scales. The study uses the CARE Women’s VOICES tool to measure governance outcomes in sexual, reproductive and maternal health programs adapted to assess family planning programs (Health Workers’ (2014) Women’s VOICES: A Tool to Measure Governance Outcomes in Sexual, Reproductive & Maternal Health Programs. Copyright 2014 Cooperative for Assistance and Relief Everywhere, Inc. (CARE). Used by Permission.)
Timepoint [6] 366350 0
A cross sectional survey using a questionnaire of accountability-related psychometric scales will be conducted with health care providers at the facilities receiving the intervention at pre (before step 1 of the intervention) and post intervention (starting immediately after completion of step 8 and completed within three months.
Secondary outcome [7] 366351 0
Dose of the intervention measured as part of the process evaluation, which uses a range of methods and data sources such as non-participant observation and in-depth interviews with key participants (community member, health providers and key stakeholders) conducted at each main event related to each step in 4 out of the 8 intervention facilities. Document review will also be used in all 8 intervention facilities as needed.
Timepoint [7] 366351 0
Non participant observation (NON) and In-depth interviews (IDI) as part of the process evaluation will be conducted during key events related to each of the eight intervention steps in four of the eight intervention facilities. One NON and up to three IDI will be conducted in relation to each key event. Document review will be done as needed in all the eight intervention facilities.
Secondary outcome [8] 366352 0
Reach of the intervention measured as part of the process evaluation, which uses a range of methods and data sources such as non-participant observation and in-depth interviews with key participants (community member, health providers and key stakeholders) conducted at each main event related to each step in 4 out of the 8 intervention facilities. Document review will also be used in all 8 intervention facilities as needed.
Timepoint [8] 366352 0
Non participant observation (NON) and In-depth interviews (IDI) as part of the process evaluation will be conducted during key events related to each of the eight intervention steps in four of the eight intervention facilities. One NON and up to three IDI will be conducted in relation to each key event. Document review will be done as needed in all the eight intervention facilities.
Secondary outcome [9] 366353 0
Fidelity of the intervention measured as part of the process evaluation, which uses a range of methods and data sources such as non-participant observation and in-depth interviews with key participants (community member, health providers and key stakeholders) conducted at each main event related to each step in 4 out of the 8 intervention facilities. Document review will be done as needed in all the eight intervention facilities.
Timepoint [9] 366353 0
Non participant observation (NON) and In-depth interviews (IDI) as part of the process evaluation will be conducted during key events related to each of the eight intervention steps in four of the eight intervention facilities. One NON and up to three IDI will be conducted in relation to each key event. Document review will be done as needed in all the eight intervention facilities.

Eligibility
Key inclusion criteria
For the measurement of changes in contraceptive uptake (facility audit), facilities meeting the following inclusion criteria will be included:
• Providing family planning
• In the study catchment area
• Public and where cost is not a barrier to access at the point of access by the client
• Agree to participate in the study
• Recorded family planning service data

For measurement of changes in contraceptive use (cohort study), individuals meeting the following inclusion criteria will be included:
• Women aged 15-49
• Accessing family planning at a participating study facility
• First time using contraception in previous 6 months
“New” users of family planning methods are defined as clients who have:
-Never used a family planning method (new acceptors)
-Are switching from a traditional to a modern family planning method (additional users)
-Are re-starting a family planning method after a period of not using it for at least 6 months (additional users)
• Willing to/anticipates to stay in the study area/district during the period of the study.
• Providing consent to participate

For evaluating social accountability intermediate outcomes (cross sectional survey), the following inclusion criteria are used:
Health professionals:
• Health professionals working in the intervention facility.
Women from the community:
• Women aged 15 to 49 years
• Accessing family planning at a participating study facility
• First time or continuing users of contraception
• Providing consent to participate

For the process evaluation, participants will be purposively and snowball sampled based on criteria including their exposure to the social accountability intervention or their role, such as a health provider or duty bearer.
Minimum age
15 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For measurement of changes in contraceptive uptake (facility audit), the following exclusion criteria will be used:
Facilities:
• Where fee for service acts as barrier to access
• Outside the study catchment area
• Not providing regular family planning services
• Do not agree to participate
• Do not record regular family planning service data

For measurement of changes in contraceptive use (cohort study), the following exclusion criteria will be used:
• Women below 15 or over 49
• Women who desire to/wish to become pregnant
• Women who have used contraception in the past 6 months
• Women who are unable or unwilling to provide consent to participate


For evaluating social accountability intermediate outcomes (cross sectional survey), the following inclusion criteria are used:
Exclusion criteria for health professional:
• Health professionals who are unable or unwilling to agree to participate
Exclusion criteria for women from the community:
• Women below 15 years
• Women who are unable or unwilling to provide consent to participate


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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
For the measurement of changes in contraceptive uptake (facility audit), the mean uptake of first use of modern contraception will be analysed as follows:
• For sample size calculations, it is assumed that, at pre-intervention, the mean number of new users per facility per month would be similar in both the intervention and control arms. It is further assumed that in the control arm, the pre-test and post-test mean number of new users per facility per month, arm will remain the same. We estimated study sample size and power two ways: with the family planning facility as the unit of measurement for Poisson regression, and with the monthly data points as the unit of measurement for time series regression. With the facility as the unit of sampling and of analysis, and assuming two-time points of interest, at pre-test (or baseline) and at post-test different sample size estimates were computed using a two-sided t-test with Type I error at 5% level, statistical power at 80%, and assuming equal variance. These various sample size estimates are provided assuming a constant denominator (included as an offset in the Poisson model) and a pooled variance for mean number of new users at pre-intervention in both arms of between 100 and 200 new users per facility, per month, and a difference in uptake per facility per month, at post-intervention of between 60 and 200 new users. We would need approximately 5 to 8 facilities per intervention or control group to detect approximately two-fold increase in rate of new users with 80% power and allowing for a 5% Type I error.
• By calculating the crude change in uptake between the control and intervention arms in terms of the rate of modern contraception first use per 10000 women, per month in the pre and post-intervention periods.
• An ITS segmented Poisson regression model will be used to estimate both the level changes in first-use modern contraception rate, and changes in time trends for rate of modern contraception first-use rates per 10,000 women-months, after the introduction of the intervention. The Generalized Estimating Equation (GEE) Poisson segmented regression model will allow adjustment for correlation due to repeated observations from the same facilities while also adjusting for important baseline family planning facility characteristics.

For measuring changes in contraceptive use (cohort study): discontinuation of modern method of contraception (first use) will be estimated as follows:
• The discontinuation rate –being a time-to-event outcome and involving censoring– necessitates the use of sample size estimation methods for survival data. Different sample size estimates were computed for values of hazard ratio (HR) (Intervention vs Control) of 0.5, 0.6 and 0.7, and given values of proportion discontinuing use of modern contraception by end of first year, in the Control arm range from 30% to 60%. Sample size estimates were obtained using a Type I error at 5% level, accrual time 0.01 year, and an exponential loss to FU of 20% that would enable a two-sided Logrank test to achieve 80% statistical power to detect difference in discontinuation rates by the end of 1 year of follow-up. The final sample size was also adjusted for clustering, due to intervention being offered at cluster level. Assuming an ICC of 0.05 and average cluster size of 20 first users of modern contraception, resulting in a design effect (DE) of 2.0, the final sample size was doubled. The sample is estimated to be 800 women over 5-8 study facilities per arm.
• Method contraception discontinuation rate (first use) will be estimated using a prospective cohort study design. The outcome of interest is time from starting use of the modern contraceptive method use to when its use is discontinued.
• For categorical variables frequencies and percentages will be reported, and for quantitative variables number of subjects, means, standard errors, medians, interquartile range, minima and maxima will be reported.
• Rate of loss to follow-up for the 1-year follow-up period will be computed by intervention arm
• The 1-year cumulative method discontinuation and method switching rates will be compared between the intervention and control arms.
• Because of the clustered nature of the outcomes, with intervention package designed at cluster level, all time-to-event outcomes including loss to follow-up, method discontinuation and method switching, will be analysed with hazard ratios estimated from the marginal Cox model and/or shared Frailty models. The model will be adjusted for baseline potential confounders at participant and/or facility level.

For evaluating social accountability intermediate outcomes (cross sectional survey):
• In intervention facilities health care professionals (2 per site at pre and at post-test) and 750 women accessing family planning services will be interviewed using the study questionnaire at two research points: baseline and endline over an 18-month period. Sampling for the women in the community will be a priori sample size calculation with the ratio of 10 subjects per item ratio and guidance of more than 500 which equals very good.
• Demographic data will be collected and analysed for representativeness.
• For the validity of the scale, an analysis the distribution of responses for individual items will be conducted and those with no variability will be removed and a reliability analysis will follow on each proposed scale with items removed in accordance with standard procedure. The distribution of overall and dimension scores will be analysed by calculating mean scores and standard deviations (SD). Floor and ceiling effect will be assessed.
• To determine internal consistency, Cronbach’s Alpha analysis will be conducted with the use of standard thresholds of 0.60 for acceptable reliability and 0.70 to be good or high reliability. Re-test will be assessed using intra-class correlation coefficient.
• We will be assessing the feasibility and acceptability of the instrument by assessing the time taken to complete the questionnaire and ease of use through analysis of the completion rate and range of missing answers.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2018
Date of last participant enrolment
Anticipated
Actual
8/02/2019
Date of last data collection
Anticipated
30/04/2020
Actual
31/08/2020
Sample size
Target
4700
Accrual to date
Final
4700
Recruitment outside Australia
Country [1] 21220 0
Ghana
State/province [1] 21220 0
Cape Coast
Country [2] 21221 0
Tanzania, United Republic Of
State/province [2] 21221 0
Mbeya District and Iringa District

Funding & Sponsors
Funding source category [1] 301718 0
Other
Name [1] 301718 0
Department of Reproductive Health and Research, which includes the the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development, World Health Organization
Country [1] 301718 0
Switzerland
Primary sponsor type
Other
Name
Department of Reproductive Health and Research, which includes the the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development, World Health Organization
Address
Avenue Appia 20, 1202 Geneva
Country
Switzerland
Secondary sponsor category [1] 301458 0
None
Name [1] 301458 0
Address [1] 301458 0
Country [1] 301458 0
Other collaborator category [1] 280500 0
Other
Name [1] 280500 0
Population Council
Address [1] 280500 0
H&C Place
204 Yiyiwa Drive
Abelemkpe
Accra
Country [1] 280500 0
Ghana
Other collaborator category [2] 280501 0
Other
Name [2] 280501 0
Ifakara Health Institute
Address [2] 280501 0
Plot 463, Kiko Avenue Mikocheni
P.O.BOX 78373
Dar Es Salaam
Country [2] 280501 0
Tanzania, United Republic Of
Other collaborator category [3] 280511 0
Other
Name [3] 280511 0
SIKIKA
Address [3] 280511 0
P.O.Box 12183,
Dar es Salaam
Country [3] 280511 0
Tanzania, United Republic Of
Other collaborator category [4] 280512 0
Other
Name [4] 280512 0
Ghana Integrity Initiative
Address [4] 280512 0
Private Mail Bag, CT 317
Cantonments, Accra
Country [4] 280512 0
Ghana

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302439 0
World Health Organization Ethics Review Committee
Ethics committee address [1] 302439 0
20, Avenue Appia
1211 Geneva
Ethics committee country [1] 302439 0
Switzerland
Date submitted for ethics approval [1] 302439 0
21/11/2017
Approval date [1] 302439 0
19/01/2018
Ethics approval number [1] 302439 0
A65896
Ethics committee name [2] 302440 0
Ghana Health Service (GHS) Ethics Review Committee
Ethics committee address [2] 302440 0
PO Box MB 190, Accra
Ethics committee country [2] 302440 0
Ghana
Date submitted for ethics approval [2] 302440 0
15/08/2017
Approval date [2] 302440 0
31/08/2017
Ethics approval number [2] 302440 0
GHS-ERC009/08/17
Ethics committee name [3] 302441 0
National Institute for Medical Research
Ethics committee address [3] 302441 0
3 Barack Obama Drive,
PO Box 9653
11101 Dar es Salaam
Ethics committee country [3] 302441 0
Tanzania, United Republic Of
Date submitted for ethics approval [3] 302441 0
25/10/2017
Approval date [3] 302441 0
11/01/2018
Ethics approval number [3] 302441 0
Ethics committee name [4] 302442 0
Ministry of Health, Community development, gender, elderly and children
Ethics committee address [4] 302442 0
Mbeya Consultant Hospital
PO Box 419, Mbeya
Ethics committee country [4] 302442 0
Tanzania, United Republic Of
Date submitted for ethics approval [4] 302442 0
05/07/2018
Approval date [4] 302442 0
12/07/2018
Ethics approval number [4] 302442 0
GB.152.37/01/214
Ethics committee name [5] 302443 0
Ghana Health Service (GHS) Ethics Review Committee
Ethics committee address [5] 302443 0
PO Box MB 190
Accra
Ethics committee country [5] 302443 0
Ghana
Date submitted for ethics approval [5] 302443 0
03/08/2018
Approval date [5] 302443 0
31/08/2018
Ethics approval number [5] 302443 0
GHS-ERC:009/08/2017

Summary
Brief summary
The research project builds on and contributes to a growing, but limited work that aims to better understand how social accountability and participatory processes in the context of family planning/contraception (FP/C) programs contributes to the greater achievement of sexual and reproductive health and improves quality of care and contraceptive uptake in FP/C services. The research project will show how a social accountability process in the context of FP programs/services influences contraceptive uptake and use. The study scales up a Community and Provider driven Social Accountability Intervention (CaPSAI) where services users and providers assess the quality of local FP/C services and jointly identify ways to improve the delivery and quality of such services.

The study contains two parts: (1) CAPTURING CHANGES IN CONTRACEPTIVE UPTAKE AND USE through a quasi-experimental pretest-posttest study using an interrupted time series in both intervention and control arms to determine the number of new users of contraception amongst women 15-49 and a cohort study of women who are new users of contraception using standardized interview questions across both intervention and control facilities to measure changes in behaviours around contraceptive use. (2) MEASURING EFFECTS OF THE SOCIAL ACCOUNTABILITY PROCESS through evaluation of social accountability intermediate outcomes using a questionnaire of psychometric scales among health providers and service users and an evaluation of the implementation of the intervention using a range of methods and data sources.
Trial website
https://www.who.int/reproductivehealth/projects/CaPSAI-Project.pdf
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90246 0
Dr Petrus S Steyn
Address 90246 0
Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, 1202 Geneva,
Country 90246 0
Switzerland
Phone 90246 0
+41 22 791 2971
Fax 90246 0
Email 90246 0
[email protected]
Contact person for public queries
Name 90247 0
Joanna Cordero
Address 90247 0
Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, 1202 Geneva,
Country 90247 0
Switzerland
Phone 90247 0
+41 22 791 2971
Fax 90247 0
Email 90247 0
[email protected]
Contact person for scientific queries
Name 90248 0
Petrus S Steyn
Address 90248 0
Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, 1202 Geneva,
Country 90248 0
Switzerland
Phone 90248 0
+41 22 791 2971
Fax 90248 0
Email 90248 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 available 1 year after primary manuscript has been published as agreed on the Data Transfer Agreement. De-identified country specific data will be available for 10 years after that.
Available to whom?
Request for de-identified data may be submitted to Primary Sponsor or 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?
Access subject to approvals by Primary Sponsor or Principal Investigators


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5905Informed consent form    Download via registry link: http://www.anzctr.org.... [More Details] 376797-(Uploaded-11-11-2019-01-52-19)-Study-related document.pdf
5906Other    Community and Provider driven Social Accountabilit... [More Details] 376797-(Uploaded-11-11-2019-01-55-29)-Study-related document.pdf
5907Other    Community and Provider driven Social Accountabilit... [More Details] 376797-(Uploaded-11-11-2019-01-58-27)-Study-related document.pdf
5908Other    Community and Provider driven Social Accountabilit... [More Details] 376797-(Uploaded-11-11-2019-02-01-51)-Study-related document.pdf
5909Other    Community and Provider driven Social Accountabilit... [More Details] 376797-(Uploaded-11-11-2019-02-03-38)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4748Study results articleYes Steyn PS, Boydell V, Cordero JP, McMullen H, Habib... [More Details] 376797-(Uploaded-08-11-2022-20-04-47)-Journal results publication.pdf
4749Study results articleYes Habib N, Steyn PS, Boydell V, Cordero JP, Nguyen M... [More Details] 376797-(Uploaded-08-11-2022-20-07-34)-Journal results publication.pdf
4750Study results articleYes McMullen H, Boydell V, Cordero JP, Steyn PS, Kiari... [More Details] 376797-(Uploaded-08-11-2022-20-08-42)-Journal results publication.pdf
4751Study results articleYes Boydell V, Steyn PS, Cordero JP, Habib N, Nguyen M... [More Details] 376797-(Uploaded-08-11-2022-20-09-44)-Journal results publication.pdf
4752Study results articleYes Steyn PS, Cordero JP, Nai D, Shamba D, Fuseini K, ... [More Details] 376797-(Uploaded-08-11-2022-20-12-34)-Journal results publication.pdf
4753Study results articleYes Community and provider-driven social accountabilit... [More Details] 376797-(Uploaded-08-11-2022-20-15-24)-Journal results publication.pdf
4754Study results articleYes Cordero JP, Mochache V, Boydell V, Addah MA, McMul... [More Details] 376797-(Uploaded-08-11-2022-20-17-41)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAdaptation and validation of social accountability measures in the context of contraceptive services in Ghana and Tanzania.2020https://dx.doi.org/10.1186/s12939-020-01286-1
EmbaseRationale and design of a complex intervention measuring the impact and processes of social accountability applied to contraceptive programming: CaPSAI Project.2020https://dx.doi.org/10.12688/gatesopenres.13075.1
EmbaseAccounting for complexity - Intervention design in the context of studying social accountability for reproductive health.2022https://dx.doi.org/10.12688/gatesopenres.13260.2
EmbaseThe impact of community and provider-driven social accountability interventions on contraceptive use: findings from a cohort study of new users in Ghana and Tanzania.2023https://dx.doi.org/10.1186/s12939-023-01928-0
Dimensions AIThe Methodological Approach to a Process Evaluation of a Community and Provider-Driven Social Accountability Intervention to Increase Contraceptive Uptake and Use2023https://doi.org/10.1177/16094069231169890
N.B. These documents automatically identified may not have been verified by the study sponsor.