ContraceptionPhase 3GCFPNCT00814411
A Trial of Group Versus Individual Family Planning Counseling in Ghana
A Phase 3 study testing group family planning counseling and Individual family planning counseling in people with Contraception, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in 2 countries.
Trial summary
This study uses a randomized, noninferiority design to determine whether group family planning counseling is as effective as individual family planning counseling among gynecological patients with unmet need at two teaching hospitals in Ghana. 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
- What is being tested?
- group family planning counseling and Individual family planning counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2008to Jul 2008
- Phase
- Phase 3
- 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
- 18 years of age and older
- fertile
- desires to delay pregnancy for at least 12 months
Who cannot join
- -
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Ghana2 sites
Korle Bu Teaching Hospital
Accra, Greater Accra Region
Komfo Anokye Teaching Hospital
Kumasi, Ashanti Region
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21218
About this study
Official title: A Randomized Trial of Group vs. Individual Family Planning Counseling in Ghana
This study uses a randomized, noninferiority design to determine whether group family planning counseling is as effective as individual family planning counseling among gynecological patients with unmet need at two teaching hospitals in Ghana.
- Conditions
- Contraception
- Being tested
- group family planning counseling, Individual family planning counseling
- Keywords
- contraception, noninferiority, intention, family planning counseling, post abortion care, Family planning intention among women with unmet need
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group family planning counselingBehavioural
group family planning counseling for gynecological patients with unmet need
Individual family planning counselingBehavioural
Individual family planning counseling with gynecological patients - the current standard of care
| Study group | Role | What they receive |
|---|---|---|
| Group Counseling | Experimental | Group family planning counseling Receives: Behavioral: group family planning counseling |
| Individual Counseling | Active comparator | Individual family planning counseling with gynecological patients who have unmet need Receives: Behavioral: Individual family planning counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive Intention
Measured: Follow-up
Secondary outcomes (1)
Modern contraceptive method knowledge
Measured: baseline and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionJul 2008
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.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 648 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Kwame Nkrumah University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814411
- Sponsor's protocol ID
- GCFP
- Acronym
- GCFP
- Status last verified
- Dec 2008
- First submitted
- 23 Dec 2008
- Last updated
- 24 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Group vs. Individual Family Planning Counseling in Ghana
- ClinicalTrials.gov ID
- NCT00814411
- Acronym / sponsor ID
- GCFP / GCFP
- Conditions
- Contraception
- Keywords
- contraception, noninferiority, intention, family planning counseling, post abortion care, Family planning intention among women with unmet need
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 648 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Kwame Nkrumah University of Science and Technology
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 24 Dec 2008 (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.
This study uses a randomized, noninferiority design to determine whether group family planning counseling is as effective as individual family planning counseling among gynecological patients with unmet need at two teaching hospitals in Ghana.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Counseling | Experimental | Behavioral: group family planning counselingGroup family planning counseling |
| Individual Counseling | Active comparator | Behavioral: Individual family planning counselingIndividual family planning counseling with gynecological patients who have unmet need |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- fertile
- desires to delay pregnancy for at least 12 months
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| group family planning counselinggroup family planning counseling for gynecological patients with unmet need | Behavioural | Group Counseling |
| Individual family planning counselingIndividual family planning counseling with gynecological patients - the current standard of care | Behavioural | Individual Counseling |
Primary outcome
Contraceptive Intention
Time frame: Follow-up
1 secondary outcome
Modern contraceptive method knowledge
Time frame: baseline and follow-up
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 24 Dec 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing group family planning counseling and Individual family planning counseling in people with Contraception, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in 2 countries.
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 3 inclusion and 1 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 24 Dec 2008. 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 Ghana, United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contraceptive Intention (time frame: Follow-up). 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 24 Dec 2008.