NCT03996941: seguiPrEP

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

Status unknown Last updated 9 July 2019

What this trial tests

trial testing Harm reduction of informal PrEP use in HIV/AIDS in 900 participants. Status unknown.

Timeline

5 July 2019

Primary endpoint
1 September 2024

1 September 2024

Quick facts

Lead sponsor	BCN Checkpoint
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	900
Start date	5 July 2019
Primary completion	1 September 2024
Estimated completion	1 September 2024
Sites	1 location across Spain

Drugs / interventions tested

• Harm reduction of informal PrEP use
• PrEP follow up based on point of care testing

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• HIV Infections — all drugs for HIV Infections →
• Sexually Transmitted Diseases — all drugs for Sexually Transmitted Diseases →
• Vaccination — all drugs for Vaccination →

Sponsor

BCN Checkpoint

Who can join

18 and older, male only, with HIV/AIDS or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.