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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03088722
Recruitment Status : Completed
First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Collaborators:
Population Council
GRM Futures Group
Marie Stopes International Organization of Nigeria
Information provided by (Responsible Party):
Marie Stopes International

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.

Condition or disease Intervention/treatment Phase
Contraception Other: Training CHEWs to provide contraceptive implants Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7903 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Task-sharing to Expand Access to Contraceptive Implants: A Study Comparing Implant Provision by Community Health Extension Workers With Nurses and Midwives in Nigeria
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

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)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Acceptability of service provision [ Time Frame: Day of implant insertion ]
    Client-reported views of implant provision

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marie Stopes International
ClinicalTrials.gov Identifier: NCT03088722     History of Changes
Other Study ID Numbers: E2331
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marie Stopes International:
Contraceptive implant
Task sharing
Nigeria

Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs