HIVPREDIVINCT02900599
Predicting Treatment and Care Difficulties Among HIV Infected Patients
An observational study of HIV, run by Centre Hospitalier de Cayenne.
Trial summary
Much of HIV is related to behaviour: sexual risk taking, late diagnosis, adherence to antiretroviral therapy, follow up, disclosure of one's HIV status. The project aimed to use various psychometric tools to determine if these scores have a predictive value on late testing, treatment succes, quality of follow up, and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jul 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV Cohort
Who may be able to join
- HIV Infected outpatient
Who cannot join
- Refusal to participate
About this study
Much of HIV is related to behaviour: sexual risk taking, late diagnosis, adherence to antiretroviral therapy, follow up, disclosure of one's HIV status. The project aimed to use various psychometric tools to determine if these scores have a predictive value on late testing, treatment succes, quality of follow up, and disclosure of HIV to sex partners. The expected outcomes would be to be able to stratify patients using a behavioural risk score and allocate targeted ressources to improve the quality of care for the most at risk patients.
- Conditions
- HIV
- Being tested
- Observationnal (no intervention)
- Keywords
- HIV, Behavior
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observationnal (no intervention)Other
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4 Count
CD4 count at diagnosis and last recorded measure
Measured: 1 year after interview
Secondary outcomes (3)
viral load
Measured: 1 year after interview
hiv disclosure to partner
Measured: at the time of interview
loss to follow up
Measured: one year after interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900599
- Sponsor's protocol ID
- PREDIVI
- Acronym
- PREDIVI
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Treatment and Care Difficulties Among HIV Infected Patients
- ClinicalTrials.gov ID
- NCT02900599
- Acronym / sponsor ID
- PREDIVI / PREDIVI
- Conditions
- HIV
- Keywords
- HIV, Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Sep 2016 (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.
Much of HIV is related to behaviour: sexual risk taking, late diagnosis, adherence to antiretroviral therapy, follow up, disclosure of one's HIV status. The project aimed to use various psychometric tools to determine if these scores have a predictive value on late testing, treatment succes, quality of follow up, and disclosure of HIV to sex partners. The expected outcomes would be to be able to stratify patients using a behavioural risk score and allocate targeted ressources to improve the quality of care for the most at risk patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV Cohort
Key inclusion criteria (1 listed)
- HIV Infected outpatient
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| Observationnal (no intervention) | Other | – |
Primary outcome
CD4 Count
Time frame: 1 year after interview
CD4 count at diagnosis and last recorded measure
3 secondary outcomes
viral load
Time frame: 1 year after interview
hiv disclosure to partner
Time frame: at the time of interview
loss to follow up
Time frame: one year after interview
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 14 Sep 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Centre Hospitalier de Cayenne.
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 14 Sep 2016. 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?
CD4 Count (time frame: 1 year after interview). 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 14 Sep 2016.