Clinical trial NCT03996941: Harm Reduction Program For Informal PrEP Users In A Community-based Setting (seguiPrEP)
Official title: Harm Reduction Program For Informal PrEP Users In A Community-based Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV/AIDS
HIV Infections
Sexually Transmitted Diseases
Vaccination
Adherence, Medication
Side Effect of Drug
Preexposure Prophylaxis
Keywords: PrEP
Community setting
point of care
Lead sponsor: BCN Checkpoint
Sponsor class: INDUSTRY
Collaborators: name: Projecte dels NOMS Hispanosida
name: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
First posted: 2019-06-25
Enrollment: 900
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of HIV and other STIs during the study period.
timeFrame: 36 months
Secondary outcomes:
measure: Number of people / visits = Number of visits / people who attend any visit
timeFrame: 36 months
measure: Retention percentage in the program
timeFrame: 36 months
measure: Number of medicines-related problems
timeFrame: 36 months
measure: Number of negative results of the medication
timeFrame: 36 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: BCN Checkpoint
Study officials:
affiliation: Fundación Lucha contra el Sida
name: Pep Coll, MD
role: PRINCIPAL_INVESTIGATOR
References: