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PAFP Provider Feedback Trial in Nepal

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03071029
Recruitment Status : Completed
First Posted : March 6, 2017
Last Update Posted : May 9, 2017
Information provided by (Responsible Party):
Kathryn Church, Marie Stopes International

Brief 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 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.

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: Monthly PAFP rates displayed at clinics. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Applying Behavioural Insights to Improve Take up of Post-abortion Family Planning: In-depth Study in Nepal
Study Start Date : July 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03071029

Show Show 36 study locations
Sponsors and Collaborators
Marie Stopes International
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Principal Investigator: Saugato Datta ideas42
Principal Investigator: Karina Lorenzana ideas42
Principal Investigator: Pragya Gartoulla, PhD Marie Stopes Nepal
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Responsible Party: Kathryn Church, Senior Scientific Advisor, Marie Stopes International Identifier: NCT03071029    
Other Study ID Numbers: 001-16
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Keywords provided by Kathryn Church, Marie Stopes International:
family planning
reproductive health
health providers