Predicting Treatment and Care Difficulties Among HIV Infe... | NCT02900599

Studies
Predicting Treatment and Care Difficulties Among HIV Infected Patients

NCT02900599

Sponsor

Centre Hospitalier de Cayenne

Status

Completed

Last Update Posted

Sep 14, 2016Estimated

Enrollment

111Actual

Phase

Not provided

Conditions

Interventions

Observationnal (no intervention)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Feb 2015Actual

Completion Date

Jul 2016Actual

First Submitted Date

Sep 6, 2016

First Submission Date that Met QC Criteria

Sep 9, 2016

First Posted Date

Sep 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2016

Last Update Posted Date

Sep 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

111Actual

Name	Type	Description	Arm Group Labels	Other Names
Observationnal (no intervention)	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CD4 Count	CD4 count at diagnosis and last recorded measure	1 year after interview

Secondary Outcomes

Measure	Description	Time Frame
viral load		1 year after interview
hiv disclosure to partner		at the time of interview
loss to follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV Infected outpatient

Exclusion Criteria:

Refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

HIV Cohort

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D001519	Behavior

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided