Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia

Not Applicable

Completed

• Conditions: Community Based Distribution; DMPA; Family Planning; Task Shifting; Contraception

• Registration Number: NCT01288274
• Lead Sponsor: University of California, Berkeley

Brief 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).

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

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-01-31
• Study First Posted: 2011-02-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1062

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Equivalence of injection administration	every 3 months	Injection site morbidities, induration etc

Secondary Outcome Measures

Name	Time	Method
Knowledge of side effects among clients	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
Equivalent continuation rates	Every 3 months	Follow up injection rates at 2nd and 3rd injection.

Trial Locations

Locations (3)

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