Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia

Contraception Clinical Trial

— CBDDMPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288274
• Other study ID #: Bixby 001
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: February 2024
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1062
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Community Based Distribution
• Contraception
• DMPA
• Family Planning
• Task Shifting

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Berkeley	Tigray Regional Health Bureau, Venture Strategies for Health and Development, Venture Strategies innovations

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equivalence of injection administration	Injection site morbidities, induration etc	every 3 months
Secondary	Equivalent continuation rates	Follow up injection rates at 2nd and 3rd injection.	Every 3 months
Secondary	Knowledge of side effects among clients	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