A Study Comparing Implant Provision by Community Health Extension Workers With Nurses and Midwives in Nigeria

March 17, 2017 updated by: Marie Stopes International

Task-sharing to Expand Access to Contraceptive Implants: A Study Comparing Implant Provision by Community Health Extension Workers With Nurses and Midwives in Nigeria

This proposed study, to be run by Marie Stopes International Organisation Nigeria (MSION) will investigate whether Community Health Extension Workers (CHEWs) in Nigeria can insert and remove contraceptive implants to the same level of safety and quality as a nurse or midwife, and whether this is acceptable to their clients and colleagues. The study will also document feasibility issues which would be relevant to any future national programmatic scale-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7903

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • facilities are located with 20km of a referral facility
  • facilities - facility staff are willing to participate, e.g. willingness to conduct family planning awareness-raising activities, willing to maintain project records
  • facilities - selected provider at each facility expects to be in the facility for the 12-month period of client recruitment
  • clients - women present to attending facilities and request a contraceptive implant

Exclusion Criteria:

  • facilities - involved in overlapping interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community health extension workers
Community health extension workers providing contraceptive implants
Other: Training CHEWs to provide contraceptive implants
Training CHEWs to provide contraceptive implants
No Intervention: Nurses and midwives
Nurses and midwives providing contraceptive implants (existing care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Day of implant insertion
Any adverse event recorded by the health provider or the client on the day of the procedure
Day of implant insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of implant provision
Time Frame: Day of implant insertion
Supervisor-recorded quality of service provision, which includes includes both clinical dimensions, such as cleanliness, and non-clinical dimensions, such as taking a client focused approach and being responsive to client needs
Day of implant insertion
Acceptability of service provision
Time Frame: Day of implant insertion
Client-reported views of implant provision
Day of implant insertion
Adverse events
Time Frame: Up to 14 days post insertion
Any adverse event recorded by the health provider at the time of implant insertion or reported by the client on the day of the procedure or up to 14 days after the procedure
Up to 14 days post insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marie Stopes International

Collaborators

Population Council
GRM Futures Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 17, 2017

First Posted (Actual)

March 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2331

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraception

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe