Clinical trial NCT03071029: PAFP Provider Feedback Trial in Nepal
Official title: Applying Behavioural Insights to Improve Take up of Post-abortion Family Planning: In-depth Study in Nepal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: family planning
reproductive health
abortion
health providers
Lead sponsor: Marie Stopes International
Sponsor class: OTHER
Collaborators: name: Ideas42
First posted: 2017-03-06
Enrollment: 12000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Long term reversible contraceptives uptake as a percentage of post-abortion family planning uptake among safe abortion clients within 2 weeks
timeFrame: 2 weeks post-abortion
Secondary outcomes:
measure: Types of family planning method used after safe abortion procedure
timeFrame: 2 weeks post abortion
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Marie Stopes Chuchchepati
state: Bagati
city: Kathmandu
country: Nepal
facility: Marie Stopes Gongabu
state: Bagati
city: Kathmandu
country: Nepal
facility: Marie Stopes Putalisadak
state: Bagmati
city: Kathmandu
country: Nepal
facility: Marie Stopes Satdobato
state: Bagmati
city: Kavre
country: Nepal
facility: Marie Stopes Banepa
state: Bagmati
city: Nuwakot
country: Nepal
facility: Marie Stopes Nuwakot
state: Bagmati
city: Banke
country: Nepal
facility: Marie Stopes Kohalpur
state: Bheri
city: Surkhet
country: Nepal
facility: Marie Stopes Surkhet
state: Bheri
city: Parbat
country: Nepal
facility: Marie Stopes Parbat
state: Dhaulagiri
city: Gorkha
country: Nepal
facility: Marie Stopes Gorkha
state: Gandaki
city: Kaski
country: Nepal
facility: Marie Stopes Pokhara
state: Gandaki
city: Tanahun
country: Nepal
facility: Marie Stopes Dumre
state: Gandaki
city: Dhanusa
country: Nepal
facility: Marie Stopes Janakpur
state: Janakpur
city: Mahottari
country: Nepal
facility: Marie Stopes Bardibas
state: Janakpur
city: Sarlahi
country: Nepal
facility: Marie Stopes Lalbandi
state: Janakpur
city: Jumla
country: Nepal
facility: Marie Stopes Jumla
state: Karnali
city: Dhankuta
country: Nepal
facility: Marie Stopes Hile
state: Koshi
city: Morang
country: Nepal
facility: Marie Stopes Biratnagar
state: Koshi
city: Sunsari
country: Nepal
facility: Marie Stopes Itahari
state: Koshi
city: Arghakhachi
country: Nepal
facility: Marie stopes Arghakhachi
state: Lumbini
city: Gulmi
country: Nepal
facility: Marie Stopes Gulmi
state: Lumbini
city: Kapilbastu
country: Nepal
facility: Marie Stopes Chandrauta
state: Lumbini
city: Kapilbastu
country: Nepal
facility: Marie Stopes Taulihawa
state: Lumbini
city: Nawalparasi
country: Nepal
facility: Marie Stopes Bardghat
state: Lumbini
city: Rupandehi
country: Nepal
facility: Marie Stopes Bhairahawa
state: Lumbini
city: Rupandehi
country: Nepal
facility: Marie Stopes Butwal
state: Lumbini
city: Dadheldhura
country: Nepal
facility: Marie Stopes Dadheldhura
state: Mahakali
city: Ilam
country: Nepal
facility: Marie Stopes Ilam
state: Mechi
city: Jhapa
country: Nepal
facility: Marie Stopes Birtamod
state: Mechi
city: Chitwan
country: Nepal
facility: Marie Stopes Narayanghat
state: Narayani
city: Makwanpur
country: Nepal
facility: Marie Stopes Hetauda
state: Narayani
city: Parsa
country: Nepal
facility: Marie Stopes Birgunj
state: Narayani
city: Dang
country: Nepal
facility: Marie Stopes Dang
state: Rapti
city: Pyuthan
country: Nepal
facility: Marie Stopes Pyuthan
state: Rapti
city: Siraha
country: Nepal
facility: Marie Stopes Lahan
state: Sagarmatha
city: Kailali
country: Nepal
facility: Marie Stopes Attariya clinic
state: Seti
Study officials:
affiliation: Ideas42
name: Saugato Datta
role: PRINCIPAL_INVESTIGATOR
affiliation: Ideas42
name: Karina Lorenzana
role: PRINCIPAL_INVESTIGATOR
affiliation: Marie Stopes Nepal
name: Pragya Gartoulla, PhD
role: PRINCIPAL_INVESTIGATOR
References: