PAFP Provider Feedback Trial in Nepal

Health Behavior Clinical Trial

Official title:

Applying Behavioural Insights to Improve Take up of Post-abortion Family Planning: In-depth Study in Nepal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071029
• Other study ID #: 001-16
• Status: Completed
• Phase: N/A
• First received: March 1, 2017
• Last updated: May 5, 2017
• Start date: July 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Marie Stopes International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Marie Stopes International	ideas42

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks post-abortion
Secondary	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.	2 weeks post abortion