HivSSVIHNCT05206123
Sexual Needs of Adolescents Living With HIV Since Childhood
An observational study of Hiv and Perinatal HIV Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To improve the knowdelge about the sexual health needs of perinatally HIV-infected adolescents living in France. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Hiv, Perinatal HIV Infection
- What is being tested?
- Interview
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2022to 7 Sep 2022
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young adults with a perinatally acquired HIV infection
Who may be able to join
- 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))
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sexual Health Needs of Adolescents Living With HIV Since Childhood : a Qualitative Study
To improve the knowdelge about the sexual health needs of perinatally HIV-infected adolescents living in France.
Read the 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.
- Conditions
- Hiv, Perinatal HIV Infection
- Being tested
- Interview
- Keywords
- HIV, sexual Health, adolescent, sexual needs
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
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
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with perinatal acquired HIV infection | group of Adolescents with perinatal acquired HIV infection Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative analysis
emerging themes describing the experience of their sexual health needs from the content analysis of the transcribed interviews
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start17 Mar 2022
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206123
- Sponsor's protocol ID
- APHP211568
- Other IDs
- 2021-A02820-41
- Acronym
- SSVIH
- Status last verified
- Jul 2023
- First submitted
- 20 Dec 2021
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Health Needs of Adolescents Living With HIV Since Childhood : a Qualitative Study
- ClinicalTrials.gov ID
- NCT05206123
- Acronym / sponsor ID
- SSVIH / APHP211568
- Conditions
- Hiv, Perinatal HIV Infection
- Keywords
- HIV, sexual Health, adolescent, sexual needs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 25 Jan 2022 (actual)
- 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents with perinatal acquired HIV infection | – | Other: Interviewgroup of Adolescents with perinatal acquired HIV infection |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adults with a perinatally acquired HIV infection
Key inclusion criteria (4 listed)
- 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))
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| InterviewPatients 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 | Other | Adolescents with perinatal acquired HIV infection |
Primary outcome
Qualitative analysis
Time frame: through study completion, an average of 1 year
emerging themes describing the experience of their sexual health needs from the content analysis of the transcribed interviews
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 10 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Perinatal HIV Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 3 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 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
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?
Qualitative analysis (time frame: through study completion, an average of 1 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 10 Jul 2023.