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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01288274
First Posted: February 2, 2011
Last Update Posted: February 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Tigray Regional Health Bureau
Venture Strategies for Health and Development
Venture Strategies innovations
Information provided by:
University of California, Berkeley
January 31, 2011
February 2, 2011
February 2, 2011
June 2008
August 2009   (Final data collection date for primary outcome measure)
Equivalence of injection administration [ Time Frame: every 3 months ]
Injection site morbidities, induration etc
Same as current
No Changes Posted
  • Equivalent continuation rates [ Time Frame: Every 3 months ]
    Follow up injection rates at 2nd and 3rd injection.
  • 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
Same as current
Not Provided
Not Provided
 
Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia
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).

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
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Contraception
  • Family Planning
  • Task Shifting
  • Community Based Distribution
  • DMPA
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 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1062
August 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Ethiopia
 
 
NCT01288274
Bixby 001
No
Not Provided
Not Provided
Ndola Prata, Scientific Director, Bixby Center, University of California, Berkeley
University of California, Berkeley
  • Tigray Regional Health Bureau
  • Venture Strategies for Health and Development
  • Venture Strategies innovations
Principal Investigator: Ndola Prata, MD, MSc Bixby Center, University of California, Berkeley
University of California, Berkeley
May 2010

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