Sexual Needs of Adolescents Living With HIV Since Childhood | NCT05206123

Studies
Sexual Needs of Adolescents Living With HIV Since Childhood

NCT05206123

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jul 10, 2023Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Hiv
Perinatal HIV Infection

Interventions

Interview

Countries

France

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

ID	Type	Description	Link
2021-A02820-41	Other Identifier	ID-RCB

Status Module

Record Verification Date

Jul 2023

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

Mar 17, 2022Actual

Primary Completion Date

Sep 7, 2022Actual

Completion Date

Sep 7, 2022Actual

First Submitted Date

Dec 20, 2021

First Submission Date that Met QC Criteria

Jan 24, 2022

First Posted Date

Jan 25, 2022Actual

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

Jul 7, 2023

Last Update Posted Date

Jul 10, 2023Actual

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

To improve the knowdelge about the sexual health needs of perinatally HIV-infected adolescents living in France.

Detailed Description

20 individual semi-structured interviews will be conducted with 20 young adults living with HIV sinc childhood and living in France. The aim of this study is to identify their sexual needs through exploring their personal experience of sexuality during their adolescence. The investigator intend to explore communication about the disease and sexuality within their families ; communication about sexual health with health care professionnals ; whether sexuality has arrose difficulties related to their chronic condition such as rejection or sadness ; whether there are differences in sexual needs regarding gender. A thematic analysis will be conducted by three researchers.

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

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adolescents with perinatal acquired HIV infection		group of Adolescents with perinatal acquired HIV infection	Other: Interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interview	Other	Patients will be interviewed with a semi-structured qualitative interview in order to know how they lived their first sexual experiences and their sex lives during their adolescence

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Qualitative analysis	emerging themes describing the experience of their sexual health needs from the content analysis of the transcribed interviews	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 25 yo
HIV-1 or HIV-2 diagnosis before the age of 13
non opposition to participate to the study
be affiliated to a social security scheme (except Aide Médicale de l'Etat (AME))

Exclusion Criteria:

having contracted HIV infection through sexual contact
persons under guardianship or custodianship, or deprived of their liberty by a judicial or administrative decision
associated illnesses or disabilities that makes participation impossible

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Young adults with a perinatally acquired HIV infection

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Maison de Solenn		Paris		75004	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided