ContraceptionCBDDMPANCT01288274
Community Based Distribution of Injectable Contraceptives in Tigray, Ethiopia
A study testing Community Based administration of DMPA in people with Contraception and Family Planning, run by University of California, Berkeley at 3 sites in Ethiopia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Family Planning, Task Shifting
- What is being tested?
- Community Based administration of DMPA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,062 participants
- Where
- 3 sitesEthiopia
- Study dates
- Jun 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Ethiopia3 sites
Kola Tembien District Health Bureau
Kola Tembien, Tigray
Tigray Regional Health Bureau
Mek'ele, Tigray
Tanqua Aberguel District Health Bureau
Tanqua Aberguel, Tigray
About this study
Official title: Safety and Feasibility of Community Based DMPA Provision in Tigray, Ethiopia
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
- Being tested
- Community Based administration of DMPA
- Keywords
- Contraception, Family planning, Task Shifting, Community based distribution, Ethiopia, DMPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Based administration of DMPAOther
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
| Study group | Role | What they receive |
|---|---|---|
| Injection by Health Extension Worker | Active comparator | Women who receive injectable contraceptive from clinic based health extension workers (HEWs) during the study period Receives: 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 Receives: Other: Community Based administration of DMPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalence of injection administration
Injection site morbidities, induration etc
Measured: every 3 months
Secondary outcomes (2)
Equivalent continuation rates
Follow up injection rates at 2nd and 3rd injection.
Measured: Every 3 months
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
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,062 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Tigray Regional Health Bureau, Venture Strategies for Health and Development, Venture Strategies innovations
- Investigators
- Ndola Prata, MD, MSc, Principal investigator, Bixby Center, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288274
- Sponsor's protocol ID
- Bixby 001
- Acronym
- CBDDMPA
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2011
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Community Based DMPA Provision in Tigray, Ethiopia
- ClinicalTrials.gov ID
- NCT01288274
- Acronym / sponsor ID
- CBDDMPA / Bixby 001
- Keywords
- Contraception, Family planning, Task Shifting, Community based distribution, Ethiopia, DMPA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,062 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Tigray Regional Health Bureau, Venture Strategies for Health and Development, Venture Strategies innovations
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection by Health Extension Worker | Active comparator | Other: Community Based administration of DMPAWomen who receive injectable contraceptive from clinic based health extension workers (HEWs) during the study period |
| Injection by Community Health Worker | Active comparator | Other: Community Based administration of DMPAWomen who receive injectable contraceptive through community based distributors from community based reproductive health agents (CBRHAs) during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Based administration of DMPAInjectable 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 | Other | Injection by Community Health Worker, Injection by Health Extension Worker |
Primary outcome
Equivalence of injection administration
Time frame: every 3 months
Injection site morbidities, induration etc
2 secondary outcomes
Equivalent continuation rates
Time frame: Every 3 months
Knowledge of side effects among clients
Time frame: Every 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ndola Prata, MD, MSc principal investigator
Bixby Center, University of California, Berkeley
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Based administration of DMPA in people with Contraception and Family Planning, run by University of California, Berkeley at 3 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence of injection administration (time frame: every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.