CBDDMPA: Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia

• Sponsor: University of California, Berkeley (Other)
• Overall Status: Completed
• CT.gov ID: NCT01288274
• Collaborator: Tigray Regional Health Bureau (Other), Venture Strategies for Health and Development (Other), Venture Strategies innovations (Other)
• Enrollment: 1,062
• Locations: 3
• Arms: 2
• Duration (Months): 14
• Patients Per Site: 354
• Patients Per Site Per Month: 25.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Contraception; Family Planning; Task Shifting; Community Based Distribution; DMPA	Other: Community Based administration of DMPA	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 1062 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Safety and Feasibility of Community Based DMPA Provision in Tigray, Ethiopia
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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; 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
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; 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

Outcome Measures

Primary Outcome Measures

1. Equivalence of injection administration [every 3 months]

   Injection site morbidities, induration etc

Secondary Outcome Measures

1. Equivalent continuation rates [Every 3 months]

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

2. Knowledge of side effects among clients [Every 3 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kola Tembien District Health Bureau	Kola Tembien	Tigray	Ethiopia
2	Tigray Regional Health Bureau	Mekelle	Tigray	Ethiopia
3	Tanqua Aberguel District Health Bureau	Tanqua Aberguel	Tigray	Ethiopia

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Ndola Prata, MD, MSc, Bixby Center, University of California, Berkeley

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01288274
• Other Study ID Numbers: Bixby 001
• First Posted: Feb 2, 2011
• Last Update Posted: Feb 2, 2011
• Last Verified: May 1, 2010

• Keywords provided by , ,: Contraception; Family planning; Task Shifting; Community based distribution; Ethiopia; DMPA

Study Results

No Results Posted as of Feb 2, 2011