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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088722
• Other study ID #: E2331
• Status: Completed
• Phase: N/A
• First received: March 10, 2017
• Last updated: March 17, 2017
• Start date: January 1, 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: March 2017
• Source: Marie Stopes International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7903
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Other:
• Training CHEWs to provide contraceptive implants
Training CHEWs to provide contraceptive implants

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Marie Stopes International	GRM Futures Group, Marie Stopes International Organization of Nigeria, Population Council

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Any adverse event recorded by the health provider or the client on the day of the procedure	Day of implant insertion
Secondary	Quality of implant provision	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
Secondary	Acceptability of service provision	Client-reported views of implant provision	Day of implant insertion
Secondary	Adverse events	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