ANZCTR - Registration

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Contraceptive use

Condition category

Condition code

Public Health

Health promotion/education

Reproductive Health and Childbirth

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Secondary outcome [5]

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]

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]

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]

Secondary outcome [7]

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]

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]

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]

Secondary outcome [9]

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]

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]

Ghana

State/province [1]

Cape Coast

Country [2]

Tanzania, United Republic Of

State/province [2]

Mbeya District and Iringa District

Funding & Sponsors

Funding source category [1]

Other

Name [1]

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 [1]

Avenue Appia 20, 1202 Geneva

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other

Name [1]

Population Council

Address [1]

H&C Place
204 Yiyiwa Drive
Abelemkpe
Accra

Country [1]

Ghana

Other collaborator category [2]

Other

Name [2]

Ifakara Health Institute

Address [2]

Plot 463, Kiko Avenue Mikocheni
P.O.BOX 78373
Dar Es Salaam

Country [2]

Tanzania, United Republic Of

Other collaborator category [3]

Other

Name [3]

SIKIKA

Address [3]

P.O.Box 12183,
Dar es Salaam

Country [3]

Tanzania, United Republic Of

Other collaborator category [4]

Other

Name [4]

Ghana Integrity Initiative

Address [4]

Private Mail Bag, CT 317
Cantonments, Accra

Country [4]

Ghana

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

World Health Organization Ethics Review Committee

Ethics committee address [1]

20, Avenue Appia
1211 Geneva

Ethics committee country [1]

Switzerland

Date submitted for ethics approval [1]

21/11/2017

Approval date [1]

19/01/2018

Ethics approval number [1]

A65896

Ethics committee name [2]

Ghana Health Service (GHS) Ethics Review Committee

Ethics committee address [2]

PO Box MB 190, Accra

Ethics committee country [2]

Ghana

Date submitted for ethics approval [2]

15/08/2017

Approval date [2]

31/08/2017

Ethics approval number [2]

GHS-ERC009/08/17

Ethics committee name [3]

National Institute for Medical Research

Ethics committee address [3]

3 Barack Obama Drive,
PO Box 9653
11101 Dar es Salaam

Ethics committee country [3]

Tanzania, United Republic Of

Date submitted for ethics approval [3]

25/10/2017

Approval date [3]

11/01/2018

Ethics approval number [3]

Ethics committee name [4]

Ministry of Health, Community development, gender, elderly and children

Ethics committee address [4]

Mbeya Consultant Hospital
PO Box 419, Mbeya

Ethics committee country [4]

Tanzania, United Republic Of

Date submitted for ethics approval [4]

05/07/2018

Approval date [4]

12/07/2018

Ethics approval number [4]

GB.152.37/01/214

Ethics committee name [5]

Ghana Health Service (GHS) Ethics Review Committee

Ethics committee address [5]

PO Box MB 190
Accra

Ethics committee country [5]

Ghana

Date submitted for ethics approval [5]

03/08/2018

Approval date [5]

31/08/2018

Ethics approval number [5]

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

Dr Petrus S Steyn

Address

Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, 1202 Geneva,

Country

Switzerland

Phone

+41 22 791 2971

Fax

[email protected]

Contact person for public queries

Name

Joanna Cordero

Address

Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, 1202 Geneva,

Country

Switzerland

Phone

+41 22 791 2971

Fax

[email protected]

Contact person for scientific queries

Name

Petrus S Steyn

Address

Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, 1202 Geneva,

Country

Switzerland

Phone

+41 22 791 2971

Fax

[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.	Type	Other Details	Attachment
5905	Informed consent form	Download via registry link: http://www.anzctr.org.... [More Details]	376797-(Uploaded-11-11-2019-01-52-19)-Study-related document.pdf
5906	Other	Community and Provider driven Social Accountabilit... [More Details]	376797-(Uploaded-11-11-2019-01-55-29)-Study-related document.pdf
5907	Other	Community and Provider driven Social Accountabilit... [More Details]	376797-(Uploaded-11-11-2019-01-58-27)-Study-related document.pdf
5908	Other	Community and Provider driven Social Accountabilit... [More Details]	376797-(Uploaded-11-11-2019-02-01-51)-Study-related document.pdf
5909	Other	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

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	Citations or Other Details	Attachment
4748	Study results article	Yes	Steyn PS, Boydell V, Cordero JP, McMullen H, Habib... [More Details]	376797-(Uploaded-08-11-2022-20-04-47)-Journal results publication.pdf
4749	Study results article	Yes	Habib N, Steyn PS, Boydell V, Cordero JP, Nguyen M... [More Details]	376797-(Uploaded-08-11-2022-20-07-34)-Journal results publication.pdf
4750	Study results article	Yes	McMullen H, Boydell V, Cordero JP, Steyn PS, Kiari... [More Details]	376797-(Uploaded-08-11-2022-20-08-42)-Journal results publication.pdf
4751	Study results article	Yes	Boydell V, Steyn PS, Cordero JP, Habib N, Nguyen M... [More Details]	376797-(Uploaded-08-11-2022-20-09-44)-Journal results publication.pdf
4752	Study results article	Yes	Steyn PS, Cordero JP, Nai D, Shamba D, Fuseini K, ... [More Details]	376797-(Uploaded-08-11-2022-20-12-34)-Journal results publication.pdf
4753	Study results article	Yes	Community and provider-driven social accountabilit... [More Details]	376797-(Uploaded-08-11-2022-20-15-24)-Journal results publication.pdf
4754	Study results article	Yes	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

Source	Title	Year of Publication	DOI
Embase	Adaptation and validation of social accountability measures in the context of contraceptive services in Ghana and Tanzania.	2020	https://dx.doi.org/10.1186/s12939-020-01286-1
Embase	Rationale and design of a complex intervention measuring the impact and processes of social accountability applied to contraceptive programming: CaPSAI Project.	2020	https://dx.doi.org/10.12688/gatesopenres.13075.1
Embase	Accounting for complexity - Intervention design in the context of studying social accountability for reproductive health.	2022	https://dx.doi.org/10.12688/gatesopenres.13260.2
Embase	The impact of community and provider-driven social accountability interventions on contraceptive use: findings from a cohort study of new users in Ghana and Tanzania.	2023	https://dx.doi.org/10.1186/s12939-023-01928-0
Dimensions AI	The Methodological Approach to a Process Evaluation of a Community and Provider-Driven Social Accountability Intervention to Increase Contraceptive Uptake and Use	2023	https://doi.org/10.1177/16094069231169890

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Did you know?

Documents added manually

Documents added automatically