PAFP Provider Feedback Trial in Nepal

NCT ID: NCT03071029

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Monthly PAFP rates displayed at clinics.

Intervention Type: BEHAVIORAL

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.

Control (no data updates)

Service providers at these clinics will not receive monthly information on PAFP LARC rates.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ideas42

INDUSTRY

Sponsor Role: collaborator

Marie Stopes International

OTHER

Sponsor Role: lead

Responsible Party

Kathryn Church

Senior Scientific Advisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saugato Datta

Role: PRINCIPAL_INVESTIGATOR

Ideas42

Karina Lorenzana

Role: PRINCIPAL_INVESTIGATOR

Ideas42

Pragya Gartoulla, PhD

Role: PRINCIPAL_INVESTIGATOR

Marie Stopes Nepal

Locations

Marie Stopes Chuchchepati

Kathmandu, Bagati, Nepal

Marie Stopes Gongabu

Kathmandu, Bagati, Nepal

Marie Stopes Putalisadak

Kathmandu, Bagmati, Nepal

Marie Stopes Satdobato

Kathmandu, Bagmati, Nepal

Marie Stopes Banepa

Kavre, Bagmati, Nepal

Marie Stopes Nuwakot

Nuwakot, Bagmati, Nepal

Marie Stopes Kohalpur

Bānke, Bheri, Nepal

Marie Stopes Surkhet

Surkhet, Bheri, Nepal

Marie Stopes Parbat

Parbat, Dhaulagiri, Nepal

Marie Stopes Gorkha

Gorkha, Gandaki, Nepal

Marie Stopes Pokhara

Kāski̇̄, Gandaki, Nepal

Marie Stopes Dumre

Tanahun, Gandaki, Nepal

Marie Stopes Janakpur

Dhanusa, Janakpur, Nepal

Marie Stopes Bardibas

Mahottari, Janakpur, Nepal

Marie Stopes Lalbandi

Sarlahi, Janakpur, Nepal

Marie Stopes Jumla

Jumla, Karnali, Nepal

Marie Stopes Hile

Dhankutā, Koshi, Nepal

Marie Stopes Biratnagar

Morang, Koshi, Nepal

Marie Stopes Itahari

Sunsari, Koshi, Nepal

Marie stopes Arghakhachi

Arghakhachi, Lumbini, Nepal

Marie Stopes Gulmi

Gulmi, Lumbini, Nepal

Marie Stopes Chandrauta

Kapilbastu, Lumbini, Nepal

Marie Stopes Taulihawa

Kapilbastu, Lumbini, Nepal

Marie Stopes Bhairahawa

Lumbini, Lumbini, Nepal

Marie Stopes Butwal

Lumbini, Lumbini, Nepal

Marie Stopes Bardghat

Nawalparasi, Lumbini, Nepal

Marie Stopes Dadheldhura

Dadheldhura, Mahakali, Nepal

Marie Stopes Ilam

Ilām, Mechi, Nepal

Marie Stopes Birtamod

Jhapa, Mechi, Nepal

Marie Stopes Narayanghat

Chitwan, Narayani, Nepal

Marie Stopes Hetauda

Makwanpur, Narayani, Nepal

Marie Stopes Birgunj

Parsa, Narayani, Nepal

Marie Stopes Dang

Dang, Rapti, Nepal

Marie Stopes Pyuthan

Pyūthān, Rapti, Nepal

Marie Stopes Lahan

Siraha, Sagarmatha, Nepal

Marie Stopes Attariya clinic

Kailāli̇̄, Seti, Nepal

Countries

Nepal

Other Identifiers

001-16

Identifier Type: -

Identifier Source: org_study_id