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Completed

NCT Number: NCT01288274

Community Based Distribution of Injectable Contraceptives 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).

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Key information

Conditions

Contraception Community Based Distribution DMPA Family Planning Task Shifting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kola Tembien District Health Bureau, Kola Tembien, Tigray, Ethiopia

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community Based administration of DMPA

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

Primary outcomes

  1. Equivalence of injection administration

    Time frame: every 3 months

    Injection site morbidities, induration etc

Secondary outcomes

  1. Equivalent continuation rates

    Time frame: Every 3 months

    Follow up injection rates at 2nd and 3rd injection.

  2. 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

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CBDDMPA

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 2, 2011
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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