Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia (CBDDMPA)

This study has been completed.

Sponsor:

Collaborators:

Tigray Regional Health Bureau

Venture Strategies for Health and Development

Venture Strategies innovations

Information provided by:

University of California, Berkeley

ClinicalTrials.gov Identifier:

NCT01288274

First received: January 31, 2011

Last updated: NA

Last verified: May 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

January 31, 2011

Last Updated Date

January 31, 2011

Start Date ^ICMJE

June 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Equivalence of injection administration [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]

Injection site morbidities, induration etc

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Equivalent continuation rates [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Follow up injection rates at 2nd and 3rd injection.
Knowledge of side effects among clients [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
The clients understand the efficacy, the drug usage, side effects and recourse for care if side effects manifest at 13 week and 6 month questionnaire

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia

Official Title ^ICMJE

Safety and Feasibility of Community Based DMPA Provision in Tigray, Ethiopia

Brief Summary

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

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Contraception
Family Planning
Task Shifting
Community Based Distribution
DMPA

Intervention ^ICMJE

Other: 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

Study Arm (s)

Active Comparator: Injection by Health Extension Worker
Women who receive injectable contraceptive from clinic based health extension workers (HEWs) during the study period

Intervention: Other: Community Based administration of DMPA
Active Comparator: 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

Intervention: Other: Community Based administration of DMPA

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1062

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Ethiopia

Administrative Information

NCT Number ^ICMJE

NCT01288274

Other Study ID Numbers ^ICMJE

Bixby 001

Has Data Monitoring Committee

Responsible Party

Ndola Prata, Scientific Director, Bixby Center, University of California, Berkeley

Study Sponsor ^ICMJE

University of California, Berkeley

Collaborators ^ICMJE

Tigray Regional Health Bureau
Venture Strategies for Health and Development
Venture Strategies innovations

Investigators ^ICMJE

Principal Investigator:

Ndola Prata, MD, MSc

Bixby Center, University of California, Berkeley

Information Provided By

University of California, Berkeley

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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