Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia

NCT ID: NCT01288274

Last Updated: 2024-02-15

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

1062 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study was to demonstrate that with appropriate training, the provision of injectable contraceptives by community based reproductive health agents (CBRHAs) does not significantly differ from low-level clinic-based providers, or health extension workers (HEWs).

Detailed Description

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The overall goal of this project was to increase contraceptive prevalence and reduce the current high unmet need for family planning in rural areas of Ethiopia. In addition, the project was intended to provide evidence to policy makers to expand community based distribution (CBD) of the injectible contraceptive, depot medroxyprogesterone acetate (DMPA), in both Tigray and other regions of Ethiopia where community based reproductive health agents (CBRHAs) or other community health workers (CHWs) are present.

Following from that, the specific aims of this project were to:

* Provide evidence that CBRHAs can safely and effectively distribute and facilitate supply of DMPA to rural women
* Demonstrate that CBRHAs can deliver DMPA with the same safety, effectiveness, and acceptability outcomes as HEWs
* Increase access to DMPA by using CBRHAs

Conditions

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Contraception Family Planning Task Shifting Community Based Distribution DMPA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Injection by Health Extension Worker

Women who receive injectable contraceptive from clinic based health extension workers (HEWs) during the study period

Group Type ACTIVE_COMPARATOR

Community Based administration of DMPA

Intervention Type OTHER

Injectable contraceptive administered by clinic based health extension worker or community based reproductive health agent using same protocol to test equivalence of community based distribution to facility based distribution

Injection by Community Health Worker

Women who receive injectable contraceptive through community based distributors from community based reproductive health agents (CBRHAs) during the study period

Group Type ACTIVE_COMPARATOR

Community Based administration of DMPA

Intervention Type OTHER

Injectable contraceptive administered by clinic based health extension worker or community based reproductive health agent using same protocol to test equivalence of community based distribution to facility based distribution

Interventions

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Community Based administration of DMPA

Injectable contraceptive administered by clinic based health extension worker or community based reproductive health agent using same protocol to test equivalence of community based distribution to facility based distribution

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All adult women of reproductive age who approached a provider for a contraceptive method and wished to use DMPA were recruited to participate in the study
* Medically eligible to use injectable contraceptives

Exclusion Criteria

* Health problems preventing or counter-indications for use of hormonal contraceptives
* Suspicion of pregancy
* FHI validated check list of eligibility use injectable contraceptives
* Minors age \<18 years old
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tigray Regional Health Bureau

UNKNOWN

Sponsor Role collaborator

Venture Strategies for Health and Development

OTHER

Sponsor Role collaborator

Venture Strategies innovations

UNKNOWN

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

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Bixby Center, University of California, Berkeley

Principal Investigators

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Ndola Prata, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Bixby Center, University of California, Berkeley

Locations

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Kola Tembien District Health Bureau

Kola Tembien, Tigray, Ethiopia

Site Status

Tigray Regional Health Bureau

Mek'ele, Tigray, Ethiopia

Site Status

Tanqua Aberguel District Health Bureau

Tanqua Aberguel, Tigray, Ethiopia

Site Status

Countries

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Ethiopia

Other Identifiers

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Bixby 001

Identifier Type: -

Identifier Source: org_study_id

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