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

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.

Conditions

• HIV/AIDS
• HIV Infections
• Sexually Transmitted Diseases
• Vaccination
• Adherence, Medication
• Side Effect of Drug
• Preexposure Prophylaxis

Interventions

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.

Sponsors & Collaborators

• Projecte dels NOMS Hispanosida

  collaborator OTHER

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

  collaborator OTHER

• BCN Checkpoint

  lead INDUSTRY

Principal Investigators

• Pep Coll, MD · Fundación Lucha contra el Sida

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-05

Primary Completion

2024-09-01

Completion

2024-09-01

Countries

• Spain

Study Locations