Harm Reduction Program For Informal PrEP Users In A Community-based Setting (seguiPrEP) (seguiPrEP)

July 6, 2019 updated by: BCN Checkpoint

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Barcelona, Spain, 08015
        • Recruiting
        • BCN CheckPoint
        • Contact:
          • Phone Number: 933182056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • People with known HIV diagnosis.
  • Absolute contraindication (eg known hypersensitivity to the active ingredients FTC or TDF) of the use of PrEP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Harm reduction of informal PrEP use

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.

Other: PrEP follow up based on point of care testing
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of HIV and other STIs during the study period.
Time Frame: 36 months
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of people / visits = Number of visits / people who attend any visit
Time Frame: 36 months

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
36 months
Retention percentage in the program
Time Frame: 36 months
% 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.
36 months
Number of medicines-related problems
Time Frame: 36 months
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
36 months
Number of negative results of the medication
Time Frame: 36 months
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
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BCN Checkpoint

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Projecte dels NOMS-Hispanosida (BCN Checkpoint and BCN PrEP·Point)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pep Coll, MD, Fundación Lucha contra el Sida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCP-FTD-2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Harm reduction of informal PrEP use

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings