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OpenTrials
Completed

NCT Number: NCT03088722

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.

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Key information

Conditions

Contraception

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training CHEWs to provide contraceptive implants

Other

Training CHEWs to provide contraceptive implants

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Marie Stopes International

Other

Collaborators

  • GRM Futures Group
  • Population Council

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 23, 2017
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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