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

NCT ID: NCT03088722

Last Updated: 2017-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7903 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Community health extension workers

Community health extension workers providing contraceptive implants

Group Type EXPERIMENTAL

Training CHEWs to provide contraceptive implants

Intervention Type OTHER

Training CHEWs to provide contraceptive implants

Nurses and midwives

Nurses and midwives providing contraceptive implants (existing care)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Training CHEWs to provide contraceptive implants

Training CHEWs to provide contraceptive implants

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Population Council

OTHER

Sponsor Role collaborator

GRM Futures Group

UNKNOWN

Sponsor Role collaborator

Marie Stopes International

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 29500162 (View on PubMed)

Other Identifiers

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E2331

Identifier Type: -

Identifier Source: org_study_id

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