Health BehaviorNCT03071029
PAFP Provider Feedback Trial in Nepal
A study testing Monthly PAFP rates displayed at clinics. in people with Health Behavior, run by Marie Stopes International at 36 sites in Nepal.
Trial summary
A six-month RCT conducted within 36 health centres throughout urban and rural Nepal. The purpose of the RCT is to test the effectiveness of a peer comparison intervention at increasing uptake of long-acting reversible contraceptives (LARCs) as a percentage of PAFP uptake among clients who receive a safe abortion at a… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Monthly PAFP rates displayed at clinics.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 36 sitesNepal
- Study dates
- Jul 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All women over the age of 18 who receive safe abortion services at the 36 centres are eligible to participate in the study. Women will be opted in to the study.
Who cannot join
- Women <18
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Nepal36 sites
Marie stopes Arghakhachi
Arghakhachi, Lumbini
Marie Stopes Kohalpur
Bānke, Bheri
Marie Stopes Narayanghat
Chitwan, Narayani
Marie Stopes Dadheldhura
Dadheldhura, Mahakali
Marie Stopes Dang
Dang, Rapti
Marie Stopes Hile
Dhankuta, Koshi
Marie Stopes Janakpur
Dhanusa, Janakpur
Marie Stopes Gorkha
Gorkha, Gandaki
Marie Stopes Gulmi
Gulmi, Lumbini
Marie Stopes Ilam
Ilām, Mechi
Marie Stopes Birtamod
Jhapa, Mechi
Marie Stopes Jumla
Jumla, Karnali
Marie Stopes Attariya clinic
Kailāli̇̄, Seti
Marie Stopes Chandrauta
Kapilbastu, Lumbini
Marie Stopes Taulihawa
Kapilbastu, Lumbini
Marie Stopes Pokhara
Kāski̇̄, Gandaki
Marie Stopes Chuchchepati
Kathmandu, Bagati
Marie Stopes Gongabu
Kathmandu, Bagati
Marie Stopes Putalisadak
Kathmandu, Bagmati
Marie Stopes Satdobato
Kathmandu, Bagmati
Marie Stopes Banepa
Kavre, Bagmati
Marie Stopes Bhairahawa
Lumbini, Lumbini
Marie Stopes Butwal
Lumbini, Lumbini
Marie Stopes Bardibas
Mahottari, Janakpur
Marie Stopes Hetauda
Makwanpur, Narayani
Marie Stopes Biratnagar
Morang, Koshi
Marie Stopes Bardghat
Nawalparasi, Lumbini
Marie Stopes Nuwakot
Nuwakot, Bagmati
Marie Stopes Parbat
Parbat, Dhaulagiri
Marie Stopes Birgunj
Parsa, Narayani
Marie Stopes Pyuthan
Pyūthān, Rapti
Marie Stopes Lalbandi
Sarlahi, Janakpur
Marie Stopes Lahan
Siraha, Sagarmatha
Marie Stopes Itahari
Sunsari, Koshi
Marie Stopes Surkhet
Surkhet, Bheri
Marie Stopes Dumre
Tanahun, Gandaki
About this study
Official title: Applying Behavioural Insights to Improve Take up of Post-abortion Family Planning: In-depth Study in Nepal
A six-month RCT conducted within 36 health centres throughout urban and rural Nepal. The purpose of the RCT is to test the effectiveness of a peer comparison intervention at increasing uptake of long-acting reversible contraceptives (LARCs) as a percentage of PAFP uptake among clients who receive a safe abortion at a Marie Stopes International Nepal. The total sample size will be ~12,000 safe abortion clients. The primary outcome of interest is LARCs among safe abortion clients at Marie Stopes Centres in Nepal. The secondary outcome is to evaluate the impact of behaviorally designed intervention on the service providers' engagement in discussing measures to increase PAFP LARC uptake among women.
Read the detailed description
The overall goal of the proposed research project is to increase uptake of long-acting reversible contraceptives (LARCs) among clients who receive a safe abortion at a Marie Stopes International - Nepal (MSI-N)/ Sunaulo Parivar Nepal (SPN) centre using a behaviourally-informed intervention: monthly feedback to service providers comparing their LARC uptake as a percentage of PAFP uptake performance to other centres. The impact of the intervention will be evaluated using a clustered, stepped wedge randomized controlled trial (RCT). The intervention will be implemented and data will be collected regularly from 36 centres over a period of 6 months. The RCT study design is stepped wedge, meaning that all health centres will begin in the control group and will be randomly assigned to begin receiving the treatment in 4 "steps". Each step will be 1 month in duration. The primary outcome of interest is LARC uptake as a percentage of PAFP uptake. The secondary outcome is type of method selected. The intervention consists of a monthly poster that centres will receive which shows service providers the PAFP LARC % performance at their centre as compared to 3 similar centres. The intervention was developed using a behavioral science methodology, including interviews with clients and service providers at 9 health centres and user-testing of the intervention with service providers at 4 health centres. Data used for this study will consist of daily PAFP LARC uptake data that is already being collected and consolidated at centres. The data will be securely shared between centres and the MSI-N central support office in Kathmandu on a weekly basis. Data will be securely shared between MSI-N and ideas monthly. Monitoring will consist of mystery client visits at each centre two times during the study period. At least one interview will be conducted with each service provider through the study period. The investigators will manually check 5% of all medical records to confirm that electronic data is accurate. Service providers will undergo written consent in order that they may choose to participate, or choose not to participate, in the study. Individual clients will be opted in to having their data shared for the purpose of the study. Clients will be notified about data sharing through posters and interactions with service providers and can choose not to have their data shared. All safe abortion clients, aged 18 and older, are eligible to have their data shared. Data from approximately 12,000 safe abortion clients will be required for the study. Strict confidentiality procedures in line with Marie Stopes International's best practices will be put into place to ensure that information made public or otherwise distributed outside the PIs and other key personnel cannot be linked to any individual client records. Results from the study will be published in a report, among other outputs, and the outcomes will be shared within MSI as well as with the wider sexual and reproductive health (SRH) community.
- Conditions
- Health Behavior
- Being tested
- Monthly PAFP rates displayed at clinics.
- Keywords
- family planning, reproductive health, abortion, health providers
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly PAFP rates displayed at clinics.Behavioural
Providers will receive visual and text feedback on their centre's PAFP uptake rates as they compare to the uptake rates of other centres. The feedback will be delivered monthly in a physical paper format.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (receive data updates) | Experimental | Intervention clinics will receive a monthly poster that centres will receive which informs service providers of the PAFP LARC uptake rate at their centre. This is a step-wedged randomised controlled trial where all the clinics will eventually receive an intervention by the end of the study. Receives: Behavioral: Monthly PAFP rates displayed at clinics. |
| Control (no data updates) | No intervention | Service providers at these clinics will not receive monthly information on PAFP LARC rates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term reversible contraceptives uptake as a percentage of post-abortion family planning uptake among safe abortion clients within 2 weeks
The study aims to observe a minimum 4% difference in PAFP LARC rates at two weeks post-abortion between intervention and control participants.
Measured: 2 weeks post-abortion
Secondary outcomes (1)
Types of family planning method used after safe abortion procedure
% of participants using different types of family planning methods at two weeks post-abortion, including % using short-acting vs long-acting contraceptives.
Measured: 2 weeks post abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study startJul 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marie Stopes International
- Sponsor type
- University, hospital or other
- Collaborators
- Ideas42
- Responsible party
- Principal investigator, Kathryn Church, Marie Stopes International
- Investigators
- Saugato Datta, Principal investigator, Ideas42Karina Lorenzana, Principal investigator, Ideas42Pragya Gartoulla, PhD, Principal investigator, Marie Stopes Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071029
- Sponsor's protocol ID
- 001-16
- Status last verified
- May 2017
- First submitted
- 1 Mar 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Behavioural Insights to Improve Take up of Post-abortion Family Planning: In-depth Study in Nepal
- ClinicalTrials.gov ID
- NCT03071029
- Acronym / sponsor ID
- 001-16
- Conditions
- Health Behavior
- Keywords
- family planning, reproductive health, abortion, health providers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- Marie Stopes InternationalUniversity, hospital or other
- Collaborators
- Ideas42
- Study start
- Jul 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A six-month RCT conducted within 36 health centres throughout urban and rural Nepal. The purpose of the RCT is to test the effectiveness of a peer comparison intervention at increasing uptake of long-acting reversible contraceptives (LARCs) as a percentage of PAFP uptake among clients who receive a safe abortion at a Marie Stopes International Nepal. The total sample size will be ~12,000 safe abortion clients. The primary outcome of interest is LARCs among safe abortion clients at Marie Stopes Centres in Nepal. The secondary outcome is to evaluate the impact of behaviorally designed intervention on the service providers' engagement in discussing measures to increase PAFP LARC uptake among women.
Detailed description
The overall goal of the proposed research project is to increase uptake of long-acting reversible contraceptives (LARCs) among clients who receive a safe abortion at a Marie Stopes International - Nepal (MSI-N)/ Sunaulo Parivar Nepal (SPN) centre using a behaviourally-informed intervention: monthly feedback to service providers comparing their LARC uptake as a percentage of PAFP uptake performance to other centres. The impact of the intervention will be evaluated using a clustered, stepped wedge randomized controlled trial (RCT). The intervention will be implemented and data will be collected regularly from 36 centres over a period of 6 months. The RCT study design is stepped wedge, meaning that all health centres will begin in the control group and will be randomly assigned to begin receiving the treatment in 4 "steps". Each step will be 1 month in duration. The primary outcome of interest is LARC uptake as a percentage of PAFP uptake. The secondary outcome is type of method selected. The intervention consists of a monthly poster that centres will receive which shows service providers the PAFP LARC % performance at their centre as compared to 3 similar centres. The intervention was developed using a behavioral science methodology, including interviews with clients and service providers at 9 health centres and user-testing of the intervention with service providers at 4 health centres. Data used for this study will consist of daily PAFP LARC uptake data that is already being collected and consolidated at centres. The data will be securely shared between centres and the MSI-N central support office in Kathmandu on a weekly basis. Data will be securely shared between MSI-N and ideas monthly. Monitoring will consist of mystery client visits at each centre two times during the study period. At least one interview will be conducted with each service provider through the study period. The investigators will manually check 5% of all medical records to confirm that electronic data is accurate. Service providers will undergo written consent in order that they may choose to participate, or choose not to participate, in the study. Individual clients will be opted in to having their data shared for the purpose of the study. Clients will be notified about data sharing through posters and interactions with service providers and can choose not to have their data shared. All safe abortion clients, aged 18 and older, are eligible to have their data shared. Data from approximately 12,000 safe abortion clients will be required for the study. Strict confidentiality procedures in line with Marie Stopes International's best practices will be put into place to ensure that information made public or otherwise distributed outside the PIs and other key personnel cannot be linked to any individual client records. Results from the study will be published in a report, among other outputs, and the outcomes will be shared within MSI as well as with the wider sexual and reproductive health (SRH) community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (receive data updates) | Experimental | Behavioral: Monthly PAFP rates displayed at clinics.Intervention clinics will receive a monthly poster that centres will receive which informs service providers of the PAFP LARC uptake rate at their centre. This is a step-wedged randomised controlled trial where all the clinics will eventually receive an intervention by the end of the study. |
| Control (no data updates) | No intervention | –Service providers at these clinics will not receive monthly information on PAFP LARC rates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women over the age of 18 who receive safe abortion services at the 36 centres are eligible to participate in the study. Women will be opted in to the study.
Key exclusion criteria (1 listed)
- Women <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monthly PAFP rates displayed at clinics.Providers will receive visual and text feedback on their centre's PAFP uptake rates as they compare to the uptake rates of other centres. The feedback will be delivered monthly in a physical paper format. | Behavioural | Intervention (receive data updates) |
Primary outcome
Long term reversible contraceptives uptake as a percentage of post-abortion family planning uptake among safe abortion clients within 2 weeks
Time frame: 2 weeks post-abortion
The study aims to observe a minimum 4% difference in PAFP LARC rates at two weeks post-abortion between intervention and control participants.
1 secondary outcome
Types of family planning method used after safe abortion procedure
Time frame: 2 weeks post abortion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saugato Datta principal investigator
Ideas42
Karina Lorenzana principal investigator
Ideas42
Pragya Gartoulla, PhD principal investigator
Marie Stopes Nepal
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly PAFP rates displayed at clinics. in people with Health Behavior, run by Marie Stopes International at 36 sites in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term reversible contraceptives uptake as a percentage of post-abortion family planning uptake among safe abortion clients within 2 weeks (time frame: 2 weeks post-abortion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.