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

NCT03996941 | Unknown

• 1 other identifier: BCP-FTD-2019-01
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

PrEP; Community setting; point of care

Outcome Measures

Primary Outcomes (1)

• Incidence of HIV and other STIs during the study period.

  36 months

Secondary Outcomes (4)

• Number of people / visits = Number of visits / people who attend any visit

  36 months

• Retention percentage in the program

  36 months

• Number of medicines-related problems

  36 months

• Number of negative results of the medication

  36 months

Study Arms (1)

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

Interventions

Harm reduction of informal PrEP use BEHAVIORAL

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.

seguiPrEP

PrEP follow up based on point of care testing OTHER

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.

seguiPrEP

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study is addressed to men who have sex with men and transgender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• BCN Checkpoint: lead
• Projecte dels NOMS Hispanosida: collaborator
• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: collaborator

Study Sites (1)

BCN Checkpoint

Barcelona, 08015, Spain

RECRUITING

Related Links

• website of BCN Checkpoint
• website of Fundación Lucha contra el Sida

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections; Sexually Transmitted Diseases; Medication Adherence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Pep Coll, MD

  Fundación Lucha contra el Sida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pep Coll, MD

CONTACT

933182056; info@hispanosida.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 25, 2019
• Study Start: July 5, 2019
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)