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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
  Purpose

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).


Condition Intervention
Contraception
Family Planning
Task Shifting
Community Based Distribution
DMPA
 Other: Community Based administration of DMPA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Safety and Feasibility of Community Based DMPA Provision in Tigray, Ethiopia

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by University of California, Berkeley:

Primary Outcome Measures:
  • Equivalence of injection administration [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
    Injection site morbidities, induration etc


Secondary Outcome Measures:
  • 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


Enrollment: 1062
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288274

Locations
Ethiopia
Kola Tembien District Health Bureau
Kola Tembien, Tigray, Ethiopia
Tigray Regional Health Bureau
Mekelle, Tigray, Ethiopia
Tanqua Aberguel District Health Bureau
Tanqua Aberguel, Tigray, Ethiopia
Sponsors and Collaborators
University of California, Berkeley
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
  More Information

No publications provided

Responsible Party: Ndola Prata, Scientific Director, Bixby Center, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT01288274     History of Changes
Other Study ID Numbers: Bixby 001
Study First Received: January 31, 2011
Last Updated: January 31, 2011
Health Authority: Ethiopia: Ministry of Health, Tigray Regional Health Bureau

Keywords provided by University of California, Berkeley:
Contraception
Family planning
Task Shifting
 Community based distribution
Ethiopia
DMPA

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013