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Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01288274
Acronym
CBDDMPA
Enrollment
1062
Registered
2011-02-02
Start date
2008-06-30
Completion date
2009-08-31
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Contraception, Family planning, Task Shifting, Community based distribution, Ethiopia, DMPA

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

Interventions

OTHERCommunity 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

Sponsors

Tigray Regional Health Bureau
CollaboratorUNKNOWN
Venture Strategies for Health and Development
CollaboratorOTHER
Venture Strategies innovations
CollaboratorUNKNOWN
University of California, Berkeley
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Equivalence of injection administrationevery 3 monthsInjection site morbidities, induration etc

Secondary

MeasureTime frameDescription
Equivalent continuation ratesEvery 3 monthsFollow up injection rates at 2nd and 3rd injection.
Knowledge of side effects among clientsEvery 3 monthsThe clients understand the efficacy, the drug usage, side effects and recourse for care if side effects manifest at 13 week and 6 month questionnaire

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026