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

February 13, 2024 updated by: University of California, Berkeley

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1062

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
    • Tigray
      • Kola Tembien, Tigray, Ethiopia
        • Kola Tembien District Health Bureau
      • Mekelle, Tigray, Ethiopia
        • Tigray Regional Health Bureau
      • Tanqua Aberguel, Tigray, Ethiopia
        • Tanqua Aberguel District Health Bureau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Equivalence of injection administration
Time Frame: every 3 months
Injection site morbidities, induration etc
every 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Equivalent continuation rates
Time Frame: Every 3 months
Follow up injection rates at 2nd and 3rd injection.
Every 3 months
Knowledge of side effects among clients
Time Frame: Every 3 months
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
Every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Berkeley

Collaborators

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

Investigators

  • Principal Investigator: Ndola Prata, MD, MSc, Bixby Center, University of California, Berkeley

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 31, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (Estimated)

February 2, 2011

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Bixby 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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