ContraceptionNCT03088722
A Study Comparing Implant Provision by Community Health Extension Workers With Nurses and Midwives in Nigeria
A study testing Training CHEWs to provide contraceptive implants in people with Contraception, run by Marie Stopes International.
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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Training CHEWs to provide contraceptive implants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,903 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- facilities - involved in overlapping interventions
About this study
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
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.
- Conditions
- Contraception
- Being tested
- Training CHEWs to provide contraceptive implants
- Keywords
- Contraceptive implant, Task sharing, Nigeria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training CHEWs to provide contraceptive implantsOther
Training CHEWs to provide contraceptive implants
| Study group | Role | What they receive |
|---|---|---|
| Community health extension workers | Experimental | Community health extension workers providing contraceptive implants Receives: Other: Training CHEWs to provide contraceptive implants |
| Nurses and midwives | No intervention | Nurses and midwives providing contraceptive implants (existing care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Any adverse event recorded by the health provider or the client on the day of the procedure
Measured: Day of implant insertion
Secondary outcomes (3)
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
Measured: Day of implant insertion
Acceptability of service provision
Client-reported views of implant provision
Measured: Day of implant insertion
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
Measured: Up to 14 days post insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Jan 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,903 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marie Stopes International
- Sponsor type
- University, hospital or other
- Collaborators
- Population Council, GRM Futures Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088722
- Sponsor's protocol ID
- E2331
- Status last verified
- Mar 2017
- First submitted
- 10 Mar 2017
- Last updated
- 23 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29500162
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03088722
- Acronym / sponsor ID
- E2331
- Conditions
- Contraception
- Keywords
- Contraceptive implant, Task sharing, Nigeria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,903 participants (actual)
- Lead sponsor
- Marie Stopes InternationalUniversity, hospital or other
- Collaborators
- Population Council, GRM Futures Group
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community health extension workers | Experimental | Other: Training CHEWs to provide contraceptive implantsCommunity health extension workers providing contraceptive implants |
| Nurses and midwives | No intervention | –Nurses and midwives providing contraceptive implants (existing care) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- facilities - involved in overlapping interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training CHEWs to provide contraceptive implantsTraining CHEWs to provide contraceptive implants | Other | Community health extension workers |
Primary outcome
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
3 secondary outcomes
Quality of implant provision
Time frame: Day of implant insertion
Acceptability of service provision
Time frame: Day of implant insertion
Adverse events
Time frame: Up to 14 days post insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Derived from this study: PubMed 29500162Reiss 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.
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Contraception
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Training CHEWs to provide contraceptive implants in people with Contraception, run by Marie Stopes International.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Day of implant insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03088722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.