PREPCoroPrEPNCT04772326
Impact of Containment and the Current Epidemic on the Sexual Risk-taking of People Using PrEP to Prevent HIV Infection.
An observational study of PREP, run by Tourcoing Hospital at 1 site in France.
Trial summary
People using PrEP to prevent HIV infection have sexual risk-taking behaviors that motivated the prescription of PrEP. Both containment and the current epidemic may affect the sexual behavior of people using PrEP and the risk of acquiring STIs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PREP
- What is being tested?
- Questionnaire
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2021to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted in all persons using PrEP as prevention against HIV infection undergoing follow-up at Tourcoing Hospital and receiving counseling during months of inclusion.
Who may be able to join
- People using PrEP for HIV prevention being followed up at Tourcoing hospital
- Having given their consent to participate in this study
- Beneficiary of a social insurance plan or entitled person
Who cannot join
- Minor patient
- Refusal to participate
- Trusteeship
- Curatorship
Trial locations and contacts
1 site in 1 country.
About this study
People using PrEP to prevent HIV infection have sexual risk-taking behaviors that motivated the prescription of PrEP. Both containment and the current epidemic may affect the sexual behavior of people using PrEP and the risk of acquiring STIs.
Hypotheses regarding the impact of the current epidemic-motivated confinement and its gradual lifting are as follows:
- A decrease in sexual risk-taking during the confinement period, followed by an increase when the confinement is lifted.
- An increase in sexual violence and the use of psychoactive substances.
- An impact on PrEP monitoring and compliance.
- An increase in the incidence of STIs when the confinement is lifted.
- Conditions
- PREP
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| PrEP patients undergoing follow-up at Tourcoing hospital | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the current epidemic on sexual risk taking of Prep users in the number of partners per month
Measured: At day 1
Impact of the current epidemic on sexual risk taking of Prep users in the number of sexual encounters per month
Measured: At day 1
Impact of the current epidemic on sexual risk taking of Prep users in the frequency of condom use during anal intercourse
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start16 Feb 2021
- Primary completion16 Mar 2022
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PREPStudies 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnes Meybeck, MD, Principal investigator, CH TOURCOING
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772326
- Sponsor's protocol ID
- RIPH_2020_10
- Acronym
- CoroPrEP
- Status last verified
- May 2022
- First submitted
- 23 Feb 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Containment and the Current Epidemic on the Sexual Risk-taking of People Using PrEP to Prevent HIV Infection.
- ClinicalTrials.gov ID
- NCT04772326
- Acronym / sponsor ID
- CoroPrEP / RIPH_2020_10
- Conditions
- PREP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- Sep 2022 (estimated)
- First posted
- 26 Feb 2021 (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.
People using PrEP to prevent HIV infection have sexual risk-taking behaviors that motivated the prescription of PrEP. Both containment and the current epidemic may affect the sexual behavior of people using PrEP and the risk of acquiring STIs.
Hypotheses regarding the impact of the current epidemic-motivated confinement and its gradual lifting are as follows:
- A decrease in sexual risk-taking during the confinement period, followed by an increase when the confinement is lifted.
- An increase in sexual violence and the use of psychoactive substances.
- An impact on PrEP monitoring and compliance.
- An increase in the incidence of STIs when the confinement is lifted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrEP patients undergoing follow-up at Tourcoing hospital | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in all persons using PrEP as prevention against HIV infection undergoing follow-up at Tourcoing Hospital and receiving counseling during months of inclusion.
Key inclusion criteria (3 listed)
- People using PrEP for HIV prevention being followed up at Tourcoing hospital
- Having given their consent to participate in this study
- Beneficiary of a social insurance plan or entitled person
Key exclusion criteria (4 listed)
- Minor patient
- Refusal to participate
- Trusteeship
- Curatorship
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 |
|---|---|---|
| QuestionnaireQuestionnaire | Other | PrEP patients undergoing follow-up at Tourcoing hospital |
Primary outcome
Impact of the current epidemic on sexual risk taking of Prep users in the number of partners per month
Time frame: At day 1
Impact of the current epidemic on sexual risk taking of Prep users in the number of sexual encounters per month
Time frame: At day 1
Impact of the current epidemic on sexual risk taking of Prep users in the frequency of condom use during anal intercourse
Time frame: At day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
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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.
Agnes Meybeck, MD principal investigator
CH TOURCOING
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 PREP, run by Tourcoing Hospital 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 May 2022. 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?
Results are not available in the source record.
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?
Impact of the current epidemic on sexual risk taking of Prep users in the number of partners per month (time frame: At day 1). The study lists 3 primary outcomes in all. 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 May 2022.