Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia

Study Overview
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Brief Summary
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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
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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

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

Conditions
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DMPA, Contraception, Family Planning, Task Shifting, Community Based Distribution

Intervention / Treatment
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* Other: Community Based administration of DMPA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Injection by Health Extension Worker<br>Women who receive injectable contraceptive from clinic based health extension workers (HEWs) during the study period | Other: Community Based administration of DMPA<br>* 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<br>|
| Active Comparator: Injection by Community Health Worker<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalence of injection administration | Injection site morbidities, induration etc | every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalent continuation rates | Follow up injection rates at 2nd and 3rd injection. | Every 3 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Family planning, Task Shifting, Community based distribution, Ethiopia, DMPA