HIV/AIDSseguiPrEPNCT03996941
Harm Reduction Program For Informal PrEP Users In A Community-based Setting (seguiPrEP)
An observational study of HIV/AIDS and HIV Infections, run by BCN Checkpoint at 1 site in Spain.
Trial summary
Pre-Exposure Prophylaxis (PrEP) is a biomedical strategy consisting of the use of antiretroviral therapy by HIV-seronegative people at high risk of acquiring HIV, to prevent the infection. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Harm reduction of informal PrEP use and PrEP follow up based on point of care testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 900 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jul 2019to 1 Sep 2024
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential participants will be those who report using or intend to use PrEP, attending the community centers on a regular or spontaneous basis. Potential participants may be recruited for the study if they meet all inclusion criteria.
Who may be able to join
- At least 18 yo at the time of the enrollment in the study.
- Accept voluntarily participation through signing informed consent, once explained its characteristics.
- Have obtained recently (less than 1 month) a negative result in the combined antigen/antibody rapid test / 4th generation ELISA or PCR HIV test.
- Active user or intending to use informal PrEP.
Who cannot join
- People with known HIV diagnosis.
- Absolute contraindication (eg known hypersensitivity to the active ingredients FTC or TDF) of the use of PrEP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Harm Reduction Program For Informal PrEP Users In A Community-based Setting
Pre-Exposure Prophylaxis (PrEP) is a biomedical strategy consisting of the use of antiretroviral therapy by HIV-seronegative people at high risk of acquiring HIV, to prevent the infection. Many controlled and randomized clinical trials, as well as implementation projects have shown that the use of tenofovir disoproxil (TDF) and emtricitabine (FTC) is both safe and effective in the prevention of HIV infection.
However, the administrative situation of PrEP in Spain is anomalous. Unlike in some European countries, PrEP is not available within the National Health System (SNS), although being available for the treatment of HIV infection. In Spain the fixed-dose combination of FTC / TDF is for hospital use only, which requires prescription by HIV specialists exclusively and restricts its dispensation to pharmacy services within the hospital.
Read more
This limitation in access and the knowledge of its prevention capacity of PrEP by vulnerable population has led them to obtain "generic FTC / TDF" outside the standardized health care system. According to a survey conducted in Europe to characterize MSM users of PrEP carried out in 2016, 5% of PrEP users had acquired it on their own. Of these 70% stated they were not included in any regular follow-up program while using the medication. Despite the growing demand, there are no health programs (including information, counseling, systematic screening for sexually transmissible infection (STI), etc.) aimed at meeting the health care needs of those who already use or wish to use PrEP, neither by public nor private healthcare providers. This type of service is especially necessary when considering that, among PrEP users, one may have already an established HIV infection, theoretical increase of other STI and a lack of monitoring kidney functions..
BCN Checkpoint is a community center since 2006 for the detection of HIV and other STI aimed at gay men, other men who have sex with men (MSM) and transgender women (TGW), which has shown high efficiency in HIV screening and fast referral to standard HIV care and treatment.. In 2017 the organization opened BCN PrEP·Point, a community centre with the goal to provide information, to conduct clinical trials and clinical monitoring of informal PrEP use.
For this reason, it is presented here the protocol of the SeguiPrEP study, prospective, longitudinal study of health care in the community environment, to MSM and TGW, users of informal PrEP, based on point-of-care testing technology.
Read the detailed description
In Catalonia 62% of new HIV diagnoses were reported in MSM in 2017. In the decade 2007-2016 in this population group an increase in the number of HIV cases of approximately 44%. The knowledge, interest and willingness to use PrEP is high among MSM at higher risk of HIV acquisition. BCN Checkpoint was accountable for the detection of one third of all new HIV cases in MSM and TGW in Catalonia.
Research hypothesis is that offering a risk reduction program, including the provision of health monitoring, in a community setting for informal PrEP users is justified and feasible, and will afford these users the possibility of using it safely. It is expected that the use of informal PrEP, along with HIV and other STIs screening, STI treatment, and immediate HIV referral to care and treatment will contribute significantly to a reduction of HIV incidence.
This study aims to contribute to increase the body of evidence on the incidence and of context specific HIV management and inform policy makers on potential preventive strategies against the epidemic.
AIMS
The primary aim of the study is:
To describe the incidence of HIV and other STIs during the study period.
The specific aims of the study are:
To provide harm reduction through clinical follow-up for informal PrEP users. To describe the conditions of informal use and acquisition of PrEP. To evaluate the effectiveness and safety of informal PrEP. To describe the demographic, clinical, risk factors for HIV and other STIs of informal PrEP users.
- Conditions
- HIV/AIDS, HIV Infections, Sexually Transmitted Diseases, Vaccination, Adherence, Medication, Side Effect of Drug
- Being tested
- Harm reduction of informal PrEP use, PrEP follow up based on point of care testing
- Keywords
- PrEP, Community setting, point of care
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harm reduction of informal PrEP useBehavioural
Users attending the study center interested in PrEP use , as well as those who could benefit from it are invited to attend an information session in which issues are touched like the effectiveness and safety of PrEP, and the characteristics of the SeguiPrEP program. This program consists of periodic clinical controls (five during the first year and four in the following period) that include: physical examination, HIV and other STI screening, control of renal functions, estimation and promotion of PrEP adherence, monitoring of adverse events associated with PrEP and counseling.
Those who decide to use PrEP or who are already using PrEP are asked to schedule an initiation visit.
PrEP follow up based on point of care testingOther
The study center has a point-of-care technology based laboratory, which allows obtaining immediate results in order to reduce the loss of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| seguiPrEP | MSM and TGW using or willing to use PrEP informally will be followed in a prospective cohort to describe safety and efficacy, and to provide them with the necessary clinical controls for using it in a safe manner. Receives: Behavioral: Harm reduction of informal PrEP use; Other: PrEP follow up based on point of care testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HIV and other STIs during the study period.
Measured: 36 months
Secondary outcomes (4)
Number of people / visits = Number of visits / people who attend any visit
This indicator will be calculated for both the number of visits and the number of people.
Disaggregation: based on sociodemographic characteristics and type of visit and PrEP guidelines
Measured: 36 months
Retention percentage in the program
% retention in the program = (People who complete the study as per protocol) / (People enrolled) x100 Disaggregation: based on sociodemographic characteristics, presence of other STIs, use of drugs and number of sexual partners.
Measured: 36 months
Number of medicines-related problems
Number of problems = Number of medicines-related problems Disaggregation:based on type of problem as per protocol, sociodemographic characteristics, use of drugs, medication, way of acquisition and other relevant factors
Measured: 36 months
Number of negative results of the medication
Number of negative results of the medication = Number of negative results of the medication Disaggregation: based on type of negative result as per protocol, sociodemographic characteristics, drug use, medication, way of acquisition and other relevant factors
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start5 Jul 2019
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BCN Checkpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Projecte dels NOMS Hispanosida, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Responsible party
- Sponsor
- Investigators
- Pep Coll, MD, Principal investigator, Fundación Lucha contra el Sida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996941
- Sponsor's protocol ID
- BCP-FTD-2019-01
- Acronym
- seguiPrEP
- Status last verified
- Jul 2019
- First submitted
- 17 Jun 2019
- Last updated
- 9 Jul 2019
- 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 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harm Reduction Program For Informal PrEP Users In A Community-based Setting
- ClinicalTrials.gov ID
- NCT03996941
- Acronym / sponsor ID
- seguiPrEP / BCP-FTD-2019-01
- Conditions
- HIV/AIDS, HIV Infections, Sexually Transmitted Diseases, Vaccination, Adherence, Medication, Side Effect of Drug
- Keywords
- PrEP, Community setting, point of care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- BCN CheckpointIndustry (pharma, biotech, devices)
- Collaborators
- Projecte dels NOMS Hispanosida, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 25 Jun 2019 (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.
Pre-Exposure Prophylaxis (PrEP) is a biomedical strategy consisting of the use of antiretroviral therapy by HIV-seronegative people at high risk of acquiring HIV, to prevent the infection. Many controlled and randomized clinical trials, as well as implementation projects have shown that the use of tenofovir disoproxil (TDF) and emtricitabine (FTC) is both safe and effective in the prevention of HIV infection.
However, the administrative situation of PrEP in Spain is anomalous. Unlike in some European countries, PrEP is not available within the National Health System (SNS), although being available for the treatment of HIV infection. In Spain the fixed-dose combination of FTC / TDF is for hospital use only, which requires prescription by HIV specialists exclusively and restricts its dispensation to pharmacy services within the hospital.
This limitation in access and the knowledge of its prevention capacity of PrEP by vulnerable population has led them to obtain "generic FTC / TDF" outside the standardized health care system. According to a survey conducted in Europe to characterize MSM users of PrEP carried out in 2016, 5% of PrEP users had acquired it on their own. Of these 70% stated they were not included in any regular follow-up program while using the medication. Despite the growing demand, there are no health programs (including information, counseling, systematic screening for sexually transmissible infection (STI), etc.) aimed at meeting the health care needs of those who already use or wish to use PrEP, neither by public nor private healthcare providers. This type of service is especially necessary when considering that, among PrEP users, one may have already an established HIV infection, theoretical increase of other STI and a lack of monitoring kidney functions..
BCN Checkpoint is a community center since 2006 for the detection of HIV and other STI aimed at gay men, other men who have sex with men (MSM) and transgender women (TGW), which has shown high efficiency in HIV screening and fast referral to standard HIV care and treatment.. In 2017 the organization opened BCN PrEP·Point, a community centre with the goal to provide information, to conduct clinical trials and clinical monitoring of informal PrEP use.
For this reason, it is presented here the protocol of the SeguiPrEP study, prospective, longitudinal study of health care in the community environment, to MSM and TGW, users of informal PrEP, based on point-of-care testing technology.
Detailed description
In Catalonia 62% of new HIV diagnoses were reported in MSM in 2017. In the decade 2007-2016 in this population group an increase in the number of HIV cases of approximately 44%. The knowledge, interest and willingness to use PrEP is high among MSM at higher risk of HIV acquisition. BCN Checkpoint was accountable for the detection of one third of all new HIV cases in MSM and TGW in Catalonia.
Research hypothesis is that offering a risk reduction program, including the provision of health monitoring, in a community setting for informal PrEP users is justified and feasible, and will afford these users the possibility of using it safely. It is expected that the use of informal PrEP, along with HIV and other STIs screening, STI treatment, and immediate HIV referral to care and treatment will contribute significantly to a reduction of HIV incidence.
This study aims to contribute to increase the body of evidence on the incidence and of context specific HIV management and inform policy makers on potential preventive strategies against the epidemic.
AIMS
The primary aim of the study is:
To describe the incidence of HIV and other STIs during the study period.
The specific aims of the study are:
To provide harm reduction through clinical follow-up for informal PrEP users. To describe the conditions of informal use and acquisition of PrEP. To evaluate the effectiveness and safety of informal PrEP. To describe the demographic, clinical, risk factors for HIV and other STIs of informal PrEP users.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| seguiPrEP | – | Behavioral: Harm reduction of informal PrEP use, Other: PrEP follow up based on point of care testingMSM and TGW using or willing to use PrEP informally will be followed in a prospective cohort to describe safety and efficacy, and to provide them with the necessary clinical controls for using it in a safe manner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants will be those who report using or intend to use PrEP, attending the community centers on a regular or spontaneous basis. Potential participants may be recruited for the study if they meet all inclusion criteria.
Key inclusion criteria (4 listed)
- At least 18 yo at the time of the enrollment in the study.
- Accept voluntarily participation through signing informed consent, once explained its characteristics.
- Have obtained recently (less than 1 month) a negative result in the combined antigen/antibody rapid test / 4th generation ELISA or PCR HIV test.
- Active user or intending to use informal PrEP.
Key exclusion criteria (2 listed)
- People with known HIV diagnosis.
- Absolute contraindication (eg known hypersensitivity to the active ingredients FTC or TDF) of the use of PrEP.
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 |
|---|---|---|
| Harm reduction of informal PrEP useUsers attending the study center interested in PrEP use , as well as those who could benefit from it are invited to attend an information session in which issues are touched like the effectiveness and safety of PrEP, and the characteristics of the SeguiPrEP program. This program consists of periodic clinical controls (five during the first year and four in the following period) that include: physical examination, HIV and other STI screening, control of renal functions, estimation and promotion of PrEP adherence, monitoring of adverse events associated with PrEP and counseling. Those who decide to use PrEP or who are already using PrEP are asked to schedule an initiation visit. | Behavioural | seguiPrEP |
| PrEP follow up based on point of care testingThe study center has a point-of-care technology based laboratory, which allows obtaining immediate results in order to reduce the loss of follow-up. | Other | seguiPrEP |
Primary outcome
Incidence of HIV and other STIs during the study period.
Time frame: 36 months
4 secondary outcomes
Number of people / visits = Number of visits / people who attend any visit
Time frame: 36 months
Retention percentage in the program
Time frame: 36 months
Number of medicines-related problems
Time frame: 36 months
Number of negative results of the medication
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- website of BCN CheckpointLink provided by the sponsor.
- website of Fundación Lucha contra el SidaLink provided by the sponsor.
- 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.
Pep Coll, MD principal investigator
Fundación Lucha contra el Sida
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/AIDS and HIV Infections, run by BCN Checkpoint at 1 site in Spain.
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 2 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 9 Jul 2019. 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 Spain. 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?
Contact Pep Coll, MD (933182056, info@hispanosida.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HIV and other STIs during the study period. (time frame: 36 months). 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 9 Jul 2019.