NCT03088722

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
7,903

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

March 10, 2017

Last Update Submit

March 17, 2017

Conditions

Keywords

Contraceptive implantTask sharingNigeria

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Any adverse event recorded by the health provider or the client on the day of the procedure

    Day of implant insertion

Secondary Outcomes (3)

  • Quality of implant provision

    Day of implant insertion

  • Acceptability of service provision

    Day of implant insertion

  • Adverse events

    Up to 14 days post insertion

Study Arms (2)

Community health extension workers

EXPERIMENTAL

Community health extension workers providing contraceptive implants

Other: Training CHEWs to provide contraceptive implants

Nurses and midwives

NO INTERVENTION

Nurses and midwives providing contraceptive implants (existing care)

Interventions

Training CHEWs to provide contraceptive implants

Community health extension workers

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • facilities - involved in overlapping interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Reiss K, Penfold S, Alabi O, Ali M, Hopkins K, Ngo TD, Odogwu K, Douthwaite M, Ezire O, Udoh U, Effiom E, Munroe ES. Safety, Quality, and Acceptability of Contraceptive Subdermal Implant Provision by Community Health Extension Workers Versus Nurses and Midwives in Nigeria: Protocol for a Quasi-Experimental, Noninferiority Study. JMIR Res Protoc. 2018 Mar 2;7(3):e67. doi: 10.2196/resprot.8721.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 23, 2017

Study Start

January 1, 2016

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

March 23, 2017

Record last verified: 2017-03