PAFP Provider Feedback Trial in Nepal

May 5, 2017 updated by: Kathryn Church, Marie Stopes International

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Bagati
      • Kathmandu, Bagati, Nepal
        • Marie Stopes Chuchchepati
      • Kathmandu, Bagati, Nepal
        • Marie Stopes Gongabu
    • Bagmati
      • Kathmandu, Bagmati, Nepal
        • Marie Stopes Putalisadak
      • Kathmandu, Bagmati, Nepal
        • Marie Stopes Satdobato
      • Kavre, Bagmati, Nepal
        • Marie Stopes Banepa
      • Nuwakot, Bagmati, Nepal
        • Marie Stopes Nuwakot
    • Bheri
      • Banke, Bheri, Nepal
        • Marie Stopes Kohalpur
      • Surkhet, Bheri, Nepal
        • Marie Stopes Surkhet
    • Dhaulagiri
      • Parbat, Dhaulagiri, Nepal
        • Marie Stopes Parbat
    • Gandaki
      • Gorkha, Gandaki, Nepal
        • Marie Stopes Gorkha
      • Kaski, Gandaki, Nepal
        • Marie Stopes Pokhara
      • Tanahun, Gandaki, Nepal
        • Marie Stopes Dumre
    • Janakpur
      • Dhanusa, Janakpur, Nepal
        • Marie Stopes Janakpur
      • Mahottari, Janakpur, Nepal
        • Marie Stopes Bardibas
      • Sarlahi, Janakpur, Nepal
        • Marie Stopes Lalbandi
    • Karnali
      • Jumla, Karnali, Nepal
        • Marie Stopes Jumla
    • Koshi
      • Dhankuta, Koshi, Nepal
        • Marie Stopes Hile
      • Morang, Koshi, Nepal
        • Marie Stopes Biratnagar
      • Sunsari, Koshi, Nepal
        • Marie Stopes Itahari
    • Lumbini
      • Arghakhachi, Lumbini, Nepal
        • Marie stopes Arghakhachi
      • Gulmi, Lumbini, Nepal
        • Marie Stopes Gulmi
      • Kapilbastu, Lumbini, Nepal
        • Marie Stopes Chandrauta
      • Kapilbastu, Lumbini, Nepal
        • Marie Stopes Taulihawa
      • Nawalparasi, Lumbini, Nepal
        • Marie Stopes Bardghat
      • Rupandehi, Lumbini, Nepal
        • Marie Stopes Bhairahawa
      • Rupandehi, Lumbini, Nepal
        • Marie Stopes Butwal
    • Mahakali
      • Dadheldhura, Mahakali, Nepal
        • Marie Stopes Dadheldhura
    • Mechi
      • Ilam, Mechi, Nepal
        • Marie Stopes Ilam
      • Jhapa, Mechi, Nepal
        • Marie Stopes Birtamod
    • Narayani
      • Chitwan, Narayani, Nepal
        • Marie Stopes Narayanghat
      • Makwanpur, Narayani, Nepal
        • Marie Stopes Hetauda
      • Parsa, Narayani, Nepal
        • Marie Stopes Birgunj
    • Rapti
      • Dang, Rapti, Nepal
        • Marie Stopes Dang
      • Pyuthan, Rapti, Nepal
        • Marie Stopes Pyuthan
    • Sagarmatha
      • Siraha, Sagarmatha, Nepal
        • Marie Stopes Lahan
    • Seti
      • Kailali, Seti, Nepal
        • Marie Stopes Attariya clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Women <18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention (receive data updates)
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.
Behavioral: 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.
No Intervention: Control (no data updates)
Service providers at these clinics will not receive monthly information on PAFP LARC rates.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 weeks post-abortion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Types of family planning method used after safe abortion procedure
Time Frame: 2 weeks post abortion
% of participants using different types of family planning methods at two weeks post-abortion, including % using short-acting vs long-acting contraceptives.
2 weeks post abortion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marie Stopes International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ideas42

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Saugato Datta, Ideas42
  • Principal Investigator: Karina Lorenzana, Ideas42
  • Principal Investigator: Pragya Gartoulla, PhD, Marie Stopes Nepal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 001-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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