ContraceptionNCT03019601
Enhancing Uptake of Family Planning Services by HIV-Infected Women Attending the PMTCT Program
A study testing Group Education in people with Contraception, run by Johns Hopkins University.
Trial summary
A specific organized program utilizing peers in the PMTCT clinic who provide family planning information and support to HIV infected mothers was compared to providing standard family planning messages currently used in the clinic. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Group Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Sep 2012
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- This being a program based intervention, all HIV positive mothers who utilize the PMTCT and post natal clinic during the study period will be enrolled.
Who cannot join
- none
About this study
Official title: Enhancing Uptake of Family Planning Services by HIV Infected Women Attending the Postpartum Component of the PMTCT Program in Mulago National Referral Hospital, Kampala, Uganda Utilizing HIV-Infected Peers as Family Planning Champions
A specific organized program utilizing peers in the PMTCT clinic who provide family planning information and support to HIV infected mothers was compared to providing standard family planning messages currently used in the clinic.
Read the detailed description
A planned group education structural intervention utilizing peers in the PMTCT clinic who provide family planning information and support to HIV infected mothers was compared to the standard of care which consisted of providing standard family planning messages to women attending the PMTCT Clinic. The study had two phases.
The Formative Phase consisted of six focus group discussions and six in depth interviews.
In the Implementation Phase, patient attendance and family planning uptake summaries for during implementation were monitored and summarized daily. Weekly average summaries were considered as time points.
- Conditions
- Contraception
- Being tested
- Group Education
- Keywords
- HIV, PMTCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group EducationBehavioural
Structured group education on family planning facilitated by Peer Champions
| Study group | Role | What they receive |
|---|---|---|
| Group education | Experimental | Non pregnant HIV+ mothers were exposed to a structured educational intervention on family planning facilitated by Peer Champions. Receives: Behavioral: Group Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of mothers who took up Family Planning
Measured: weekly for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startSep 2011
- Primary completionJun 2012
- Study completionSep 2012
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 UniversityThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- MU-JHU CARE, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Peter Mudiope, MBChB, MSc, Principal investigator, MU-JHU CARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019601
- Sponsor's protocol ID
- NA_00048133
- Other IDs
- UM1AI069530
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Uptake of Family Planning Services by HIV Infected Women Attending the Postpartum Component of the PMTCT Program in Mulago National Referral Hospital, Kampala, Uganda Utilizing HIV-Infected Peers as Family Planning Champions
- ClinicalTrials.gov ID
- NCT03019601
- Acronym / sponsor ID
- NA_00048133
- Conditions
- Contraception
- Keywords
- HIV, PMTCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,300 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- MU-JHU CARE, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Jan 2017 (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.
A specific organized program utilizing peers in the PMTCT clinic who provide family planning information and support to HIV infected mothers was compared to providing standard family planning messages currently used in the clinic.
Detailed description
A planned group education structural intervention utilizing peers in the PMTCT clinic who provide family planning information and support to HIV infected mothers was compared to the standard of care which consisted of providing standard family planning messages to women attending the PMTCT Clinic. The study had two phases.
The Formative Phase consisted of six focus group discussions and six in depth interviews.
In the Implementation Phase, patient attendance and family planning uptake summaries for during implementation were monitored and summarized daily. Weekly average summaries were considered as time points.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group education | Experimental | Behavioral: Group EducationNon pregnant HIV+ mothers were exposed to a structured educational intervention on family planning facilitated by Peer Champions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- This being a program based intervention, all HIV positive mothers who utilize the PMTCT and post natal clinic during the study period will be enrolled.
Key exclusion criteria (1 listed)
- none
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 EducationStructured group education on family planning facilitated by Peer Champions | Behavioural | Group education |
Primary outcome
proportion of mothers who took up Family Planning
Time frame: weekly for one year
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 12 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Peter Mudiope, MBChB, MSc principal investigator
MU-JHU CARE
Questions about this trial
What is this clinical trial studying?
A study testing Group Education in people with Contraception, run by Johns Hopkins University.
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 1 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
proportion of mothers who took up Family Planning (time frame: weekly for one year). 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 12 Jan 2017.