NCT03071029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

March 1, 2017

Last Update Submit

May 5, 2017

Conditions

Keywords

family planningreproductive healthabortionhealth providers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Types of family planning method used after safe abortion procedure

    2 weeks post abortion

Study Arms (2)

Intervention (receive data updates)

EXPERIMENTAL

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.

Control (no data updates)

NO INTERVENTION

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

Interventions

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 (receive data updates)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Women \<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Marie Stopes Chuchchepati

Kathmandu, Bagati, Nepal

Location

Marie Stopes Gongabu

Kathmandu, Bagati, Nepal

Location

Marie Stopes Putalisadak

Kathmandu, Bagmati, Nepal

Location

Marie Stopes Satdobato

Kathmandu, Bagmati, Nepal

Location

Marie Stopes Banepa

Kavre, Bagmati, Nepal

Location

Marie Stopes Nuwakot

Nuwakot, Bagmati, Nepal

Location

Marie Stopes Kohalpur

Bānke, Bheri, Nepal

Location

Marie Stopes Surkhet

Surkhet, Bheri, Nepal

Location

Marie Stopes Parbat

Parbat, Dhaulagiri, Nepal

Location

Marie Stopes Gorkha

Gorkha, Gandaki, Nepal

Location

Marie Stopes Pokhara

Kāski̇̄, Gandaki, Nepal

Location

Marie Stopes Dumre

Tanahun, Gandaki, Nepal

Location

Marie Stopes Janakpur

Dhanusa, Janakpur, Nepal

Location

Marie Stopes Bardibas

Mahottari, Janakpur, Nepal

Location

Marie Stopes Lalbandi

Sarlahi, Janakpur, Nepal

Location

Marie Stopes Jumla

Jumla, Karnali, Nepal

Location

Marie Stopes Hile

Dhankutā, Koshi, Nepal

Location

Marie Stopes Biratnagar

Morang, Koshi, Nepal

Location

Marie Stopes Itahari

Sunsari, Koshi, Nepal

Location

Marie stopes Arghakhachi

Arghakhachi, Lumbini, Nepal

Location

Marie Stopes Gulmi

Gulmi, Lumbini, Nepal

Location

Marie Stopes Chandrauta

Kapilbastu, Lumbini, Nepal

Location

Marie Stopes Taulihawa

Kapilbastu, Lumbini, Nepal

Location

Marie Stopes Bhairahawa

Lumbini, Lumbini, Nepal

Location

Marie Stopes Butwal

Lumbini, Lumbini, Nepal

Location

Marie Stopes Bardghat

Nawalparasi, Lumbini, Nepal

Location

Marie Stopes Dadheldhura

Dadheldhura, Mahakali, Nepal

Location

Marie Stopes Ilam

Ilām, Mechi, Nepal

Location

Marie Stopes Birtamod

Jhapa, Mechi, Nepal

Location

Marie Stopes Narayanghat

Chitwan, Narayani, Nepal

Location

Marie Stopes Hetauda

Makwanpur, Narayani, Nepal

Location

Marie Stopes Birgunj

Parsa, Narayani, Nepal

Location

Marie Stopes Dang

Dāng, Rapti, Nepal

Location

Marie Stopes Pyuthan

Pyūthān, Rapti, Nepal

Location

Marie Stopes Lahan

Siraha, Sagarmatha, Nepal

Location

Marie Stopes Attariya clinic

Kailāli̇̄, Seti, Nepal

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Saugato Datta

    Ideas42

    PRINCIPAL INVESTIGATOR
  • Karina Lorenzana

    Ideas42

    PRINCIPAL INVESTIGATOR
  • Pragya Gartoulla, PhD

    Marie Stopes Nepal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientific Advisor

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 6, 2017

Study Start

July 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations