CClinicalTrials.gg
CompletedNCT01288274CBDDMPAUpdated Feb 15, 2024

Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia

An interventional study of Community Based administration of DMPA in Contraception, Family Planning and Task Shifting, sponsored by University of California, Berkeley. Completed at 3 sites in Ethiopia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-15.

Sponsored by University of California, Berkeley · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,062
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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).

Read the 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
02

Conditions studied

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

Keywords

  • Contraception
  • Family planning
  • Task Shifting
  • Community based distribution
  • Ethiopia
  • DMPA
03

In context

Lead sponsor

University of California, Berkeley is the lead sponsor of 106 studies on the registry; 18 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,062 participants (actual)

Study arms

  • Active comparator
    Injection by Health Extension Worker

    Women who receive injectable contraceptive from clinic based health extension workers (HEWs) during the study period

    Other: Community Based administration of DMPA

  • Active comparator
    Injection by Community Health Worker

    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

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

06

What researchers measure

Primary outcomes

  1. Equivalence of injection administration

    Injection site morbidities, induration etc

    Time frame: every 3 months

Secondary outcomes

  1. Equivalent continuation rates

    Follow up injection rates at 2nd and 3rd injection.

    Time frame: Every 3 months

  2. 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

    Time frame: Every 3 months

07

Study locations

3 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01288274
Lead sponsor
University of California, Berkeley
Collaborators
Tigray Regional Health Bureau, Venture Strategies for Health and Development, Venture Strategies innovations
First posted
Feb 2, 2011
Start date
Jun 2008
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Feb 15, 2024

Study contacts

Ndola Prata, MD, MSc
principal investigator · Bixby Center, University of California, Berkeley

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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