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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01288274
Other study ID # Bixby 001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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