Clinical trial NCT01288274: Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia
Official title: Safety and Feasibility of Community Based DMPA Provision in Tigray, Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Family Planning
Task Shifting
Community Based Distribution
DMPA
Keywords: Contraception
Family planning
Task Shifting
Community based distribution
Ethiopia
DMPA
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Tigray Regional Health Bureau
name: Venture Strategies for Health and Development
name: Venture Strategies innovations
First posted: 2011-02-02
Enrollment: 1062
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Equivalence of injection administration
timeFrame: every 3 months
Secondary outcomes:
measure: Equivalent continuation rates
timeFrame: Every 3 months
measure: Knowledge of side effects among clients
timeFrame: Every 3 months
Other outcomes:
Locations:
city: Kola Tembien
country: Ethiopia
facility: Kola Tembien District Health Bureau
state: Tigray
city: Mekelle
country: Ethiopia
facility: Tigray Regional Health Bureau
state: Tigray
city: Tanqua Aberguel
country: Ethiopia
facility: Tanqua Aberguel District Health Bureau
state: Tigray
Study officials:
affiliation: Bixby Center, University of California, Berkeley
name: Ndola Prata, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: