Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia

NCT01288274 | Completed

• 1 other identifier: Bixby 001
• Study Type: interventional
• Target: 1,062
• Locations: 1 country
• Sites: 3

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Equivalence of injection administration

  Injection site morbidities, induration etc

  every 3 months

Secondary Outcomes (2)

• Equivalent continuation rates

  Every 3 months

• Knowledge of side effects among clients

  Every 3 months

Study Arms (2)

Injection by Health Extension Worker

ACTIVE COMPARATOR

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

Other: Community Based administration of DMPA

Injection by Community Health Worker

ACTIVE COMPARATOR

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

Community Based administration of DMPA OTHER

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

Injection by Community Health Worker; Injection by Health Extension Worker

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• Tigray Regional Health Bureau: collaborator
• Venture Strategies for Health and Development: collaborator
• Venture Strategies innovations: collaborator

Study Sites (3)

Kola Tembien District Health Bureau

Kola Tembien, Tigray, Ethiopia

Location

Tigray Regional Health Bureau

Mek'ele, Tigray, Ethiopia

Location

Tanqua Aberguel District Health Bureau

Tanqua Aberguel, Tigray, Ethiopia

Location

Study Officials

• Ndola Prata, MD, MSc

  Bixby Center, University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 2, 2011
• Study Start: June 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

ET (3)