HIV Infections Clinical Trial
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.
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |