HIV Infection PrimarySeVIHPrEPNCT05492565
Seville Cohort of People at Substantial Risk for HIV Infection on Pre-exposure Prophylaxis
An observational study of HIV Infection Primary and Hepatitis, Viral, Human, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
Trial summary
Pre-exposure prophylaxis (PrEP) based on tenofovir represents a considerably new preventive intervention that has shown to significantly decrease the number of HIV infections while it enables early diagnosis of HIV and other sexually transmitted diseases (STI). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection Primary, Hepatitis, Viral, Human, Sexually Transmitted Infections, Excluding HIV and Hepatitis
- What is being tested?
- Tenofovir Disoproxil Fumarate 300 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participants of the SeVIHPrEP cohort are recruited from the candidates for a PrEP programme derived from the outpatient STI clinic at the Clinical Unit of Infecious Diseases and Preventive Medicine (Unidad Clínica de Enfermedades Infecciosas y Medicina Preventiva, UCEIMP) of the Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío) in Seville, Spain. Candidates are informed about the SeVIHPrEP protocol, an information sheet is handed out and additionally, the study is explained by the physician. They are then invited to participate in the cohort and upon acceptance, are asked to sign a written informed consent.
Who may be able to join
- HIV negative as demonstrated by negative HIV serology as determined by EIA and Western-Blot.
- Older than 18 years.
- At high risk of acquiring HIV infection by sexual transmission.
- MSM and transsexual persons who met at least two of the following criteria during the year prior to visit:
- More than ten different sexual partners.
- Anal sexual intercourse without using a condom.
Show all 11Show fewer
- Consumption of drugs in order to establish and/or maintain sexual relations without condom.
- Administration of post-exposition prophylaxis in various occasions de profilaxis post- exposición en varias ocasiones.
- At least one bacterial STI.
- Women who prostitute themselves with no or irregular use of a condom. -Start daily or on-demand PrEP with TDF/FTC.
- Give their written informed consent to participate in the cohort and its substudies.
Who cannot join
- Glomerular filtration rate <60 ml/min.
- For on-demand PrEP: diagnosis of chronic hepatitis B.
- Allergic to TDF and/or FTC.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study to Evaluate Clinical Benefits and Drawbacks of Antiretroviral Drugs as Pre-exposure Prophylaxis to Prevent HIV Infection Under Real-life Conditions Among Persons Who Pursue High-risk Sexual Practices: The Seville HIV PrEP Cohort
Pre-exposure prophylaxis (PrEP) based on tenofovir represents a considerably new preventive intervention that has shown to significantly decrease the number of HIV infections while it enables early diagnosis of HIV and other sexually transmitted diseases (STI).
In Southern Spain, the target population to receive PrEP are men who have sex with men (MSM) with a history of STI and who pursue high-risk sexual practices regarding the acquisition of HIV, including an elevate number of sex partners, no or inconsistent condom use and the use of specific recreational drugs in the context of sexual activity ("chemsex").
Read more
Despite the benefits of PrEP use, it must be taken into consideration that risk compensations that may facilitate the acquisition of other STI may occur, including a higher implementation of risk practices and an increase in the number of partners, which is made easy as various social networks designed for this purpose are available nowadays.
In order to better understand the benefit/drawback ratio, accurate data of a population using PrEP under real-life conditions, with densely scheduled follow-up and well-characterized (socio-)demographic parameters, sexual behaviour and STI are warranted.
Read the detailed description
To date, the availability of highly-active antiretroviral drugs enables an efficient and persistent suppression of HIV replication. This, on the one hand, results in a considerably higher life expectancy and quality of life among persons living with HIV (PLWH) and, on the other hand, reduces the risk of viral transmission. Based on these advances, the Joint United Nations Programme on HIV/AIDS (UNAIDS) has developed strategies aiming to end the HIV/AIDS epidemic by including preventive tools. With the aim to prevent the acquisition of HIV infection, recommendations for the use of post-exposure prophylaxis were established, however, this strategy requires both the awareness of having been exposed to the virus, as well as the access to treatment within 72 hours after exposure, which represents important limitations when put into practice. To overcome these obstacles, pre-exposure prophylaxis has been implemented during the last decade.
PrEP represents a preventive intervention that has demonstrated a significant decrease in HIV infections in a large number of randomized clinical trials and observational studies among various populations. Apart from the preventive benefits, it furthermore supports the early diagnosis of HIV and other sexually transmitted diseases (STI), leading to the World Health Organisation (WHO) to recommend its use in 2012. As a result of a complex analysis including efficacy, risks and costs, PrEP was only recommended for persons at substantial risk to get infected. Main representatives are men who have sex with men (MSM), in whom a decrease of 44%-86% in HIV infection in pilot clinical trials was observed, as well as transgender women and persons with an HIV-positive partner. Among those compliant to daily PrEP, infection rates become close to zero. Although the majority of the guidelines are based on this modality, there is evidence that MSM showing less frequent sexual activity could also benefit from on-demand PrEP. In comparison with daily PrEP, the on-demand modality encourages adherence due to its contemporaneous use with the sexual intercourse.
So far, the WHO recommendations have been adapted in clinical guidelines of more than 60% of the countries worldwide, showing an increasing trend and promising results, as reported from ongoing PrEP programmes. In Spain, the use of PrEP based on tenofovir (TNF) and emtricitabine has demonstrated its benefit in a study to evaluate PrEP implementation in four Spanish settings. Subsequently, the Interministerial Commission for Medical Costs of the Spanish government approved financial support for PrEP in specific risk groups for HIV acquisition as defined by the National AIDS Plan (Plan Nacional sobre el SIDA, PNS) and since September of 2019, PrEP represents an integral part of the Andalusian Health System services. In this context, PrEP is offered as complementary preventive tool included in a package aimed to raise awareness in persons at high risk for HIV infection in order to break the chain of transmission and warrant required health care. Thus, in the setting of Seville, Andalusia (Spain), the main candidates to receive PrEP are MSM with a history of STI and high-risk sexual behaviour, including an elevated number of sex partners, no or rare use of condoms and chemsex. The latter refers to a relatively new trend in the MSM community and describes the use of specific recreational drugs, mainly metamphetamine, mephedrone, poppers or gammahydroxybutyrate (GHB)/gammabutyrolactone (GBL) in any combination or route of administration, in the context of sexual activity with one, but often multiple partners. Chemsex is associated with high-risk sex practices and the acquisition of STI.
Despite the high interest in this preventive tool, real-life data on PrEP use are scarce, the sexual habits among its users are not well characterised and there is no information available for Andalusia, and especially the region of Seville, where the number of candidates for PrEP is estimated to exceed 1000 according to the Andalusian Plan against HIV/AIDS and other STI (Plan Andaluz frente al VIH/SIDA y otras ITS, PASIDA). Likewise, while the of primary HIV infections during PrEP are likely rare-to-absent, they cannot be excluded and their characteristics and clinical management are poorly studied. Additionally, in spite of the benefit of PrEP, there are various considerations regarding its use, like the development of adverse events on the short or long term in healthy people taking antiretroviral drugs, as in the case of TNF, renal function and bone density may be affected. Another major concern is the possibility of risk compensation in persons who feel less vulnerable due to the protective effect of PrEP. This could be manifested in a shift of sexual habits towards high-risk behaviour and/or an increase in the number of sex partners which can be achieved comfortably while remaining anonymous, given the social networks designed for this purpose available nowadays. Consequently, transmission of other STI, unintended pregnancies and resistance to TNF in case of primary HIV infection would be encouraged. Studies under real-life conditions including frequent and detailed monitoring are strongly needed in order to gain knowledge on the possible impact of PrEP on its users, taking into account possible changes in life style caused by the constant evolution of society and social media, like dating applications. In fact, a change in the social profile of MSM newly diagnosed with HIV infection has been reported recently in Madrid, which supports the need to improve the characterization and motorization of those participating in PrEP programmes.
In order to clarify this issue, accurate data of a population using PrEP under real-life conditions, with densely scheduled follow-up and well-characterized (socio-)demographic parameters, sexual behaviour and STI are warranted.
- Conditions
- HIV Infection Primary, Hepatitis, Viral, Human, Sexually Transmitted Infections, Excluding HIV and Hepatitis
- Being tested
- Tenofovir Disoproxil Fumarate 300 MG Oral Tablet
- Keywords
- PrEP, tenofovir disoproxyl fumarate, emtricitabine, HIV, Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, human papillomavirus, men who have sex with men, ChemSex
- Medical subject headings
- Hepatitis, Viral, Human, Sexually Transmitted Diseases, Hepatitis, Treponemal Infections, Homosexuality, Chemsex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil Fumarate 300 MG Oral TabletDrug
Also called Emtricitabine 200 MG Oral Tablet
Pre-exposure prophylaxis with coformulated Tenofovir Disoproxil Fumarate 300mg/Emtricitabine 200mg oral QD to prevent HIV infection
| Study group | Role | What they receive |
|---|---|---|
| Men who have sex with men | Men who have sex with men at substantial risk for HIV infection due to high-risk sexual habits Receives: Drug: Tenofovir Disoproxil Fumarate 300 MG Oral Tablet | |
| Transgender women | Transgender women at substantial risk for HIV infection due to high-risk sexual habits Receives: Drug: Tenofovir Disoproxil Fumarate 300 MG Oral Tablet | |
| Sex workers | Sex workers at substantial risk for HIV infection due to high-risk sexual habits Receives: Drug: Tenofovir Disoproxil Fumarate 300 MG Oral Tablet | |
| HIV-uninfected people at substantial risk for HIV infection (other) | All HIV-uninfected people at substantial risk for HIV infection due to any other reason, including having an HIV-positive life partnerwith an HIV-positive life partner Receives: Drug: Tenofovir Disoproxil Fumarate 300 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline proportion of PrEP users with STI-4c at one year
Analysis of a change in the proportion of persons that present with infection by at least one of the following four common sexually transmitted pathogens (STI-4c): Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis and/or Mycoplasma genitalium.
Measured: Baseline through one year
Incidence of primary HIV infection
Determination of the incidence of primary HIV infections during PrEP use
Measured: Through study completion (an average 3 years)
Secondary outcomes (8)
Proportion of PrEP users with STI other than STI-4c or HIV
Determination of the proportion of persons that present with STI other than those analysed in the primary outcome
Measured: Through study completion (an average 3 years)
Number of STI
Determination of the number of STI PrEP users present with STI at the scheduled visits
Measured: Through study completion (an average 3 years)
Incidences of STI other than HIV
Determination of the incidences of individual STI other than HIV
Measured: Through study completion (an average 3 years)
Sexual behaviour
Determination of the number of distinct sexual risk practices conducted per person since the last study visit
Measured: Through study completion (an average 3 years)
Adverse events
Determination of the rate of adverse events related to the antiretroviral drugs used for PrEP
Measured: Through study completion (an average 3 years)
Adherence to PrEP
Evaluation of the adherence to PrEP modalities (daily PrEP: proportion of days PrEP was taken; on-demand PrEP: proportion of sexual intercourse with PrEP)
Measured: Through study completion (an average 3 years)
Predictors of the incidence of HIV and other STI
Identification of factors associated with the incidence of HIV infection and STI other than HIV
Measured: Through study completion (an average 3 years)
Predictors of a change in the proportion of STI-4c
Identification of factors associated with a change in the proportion of STI-4c
Measured: Baseline through one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for HIV Infection PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Biomedicina de Sevilla
- Responsible party
- Principal investigator, Karin Neukam, Hospitales Universitarios Virgen del Rocío
- Investigators
- Karin Neukam, PharmD, PhD, Study director, Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de SevillaCésar Sotomayor de la Piedra, MD, Principal investigator, Hospitales Universitarios Virgen del RocíoMarta Herrero Romero, MD, PhD, Principal investigator, Hospitales Universitarios Virgen del RocíoAlicia Gutiérrez Valencia, PharmD, PhD, Principal investigator, Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de SevillaLuis F López-Cortés, MD, PhD, Principal investigator, Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492565
- Sponsor's protocol ID
- SeVIHPrEP Cohort
- Other IDs
- FIS-PRE-2022-01
- Acronym
- SeVIHPrEP
- Status last verified
- Sep 2023
- First submitted
- 30 Jul 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Donnell D, Baeten JM, Kiarie J, Thomas KK, Stevens W, Cohen CR, McIntyre J, Lingappa JR, Celum C; Partners in Prevention HSV/HIV Transmission Study Team. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet. 2010 Jun 12;375(9731):2092-8. doi: 10.1016/S0140-6736(10)60705-2. Epub 2010 May 26.
PubMed 20537376Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR; HPTN 052 Study Team. Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med. 2016 Sep 1;375(9):830-9. doi: 10.1056/NEJMoa1600693. Epub 2016 Jul 18.
PubMed 27424812Smith DK, Grohskopf LA, Black RJ, Auerbach JD, Veronese F, Struble KA, Cheever L, Johnson M, Paxton LA, Onorato IM, Greenberg AE; U.S. Department of Health and Human Services. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep. 2005 Jan 21;54(RR-2):1-20.
PubMed 15660015Guideline on When to Start Antiretroviral Therapy and on Pre-Exposure Prophylaxis for HIV. Geneva: World Health Organization; 2015 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK327115/
PubMed 26598776Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Preau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Dore V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.
PubMed 26624850Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.
PubMed 21091279Spinner CD, Boesecke C, Zink A, Jessen H, Stellbrink HJ, Rockstroh JK, Esser S. HIV pre-exposure prophylaxis (PrEP): a review of current knowledge of oral systemic HIV PrEP in humans. Infection. 2016 Apr;44(2):151-8. doi: 10.1007/s15010-015-0850-2. Epub 2015 Oct 15.
PubMed 26471511Antoni G, Tremblay C, Delaugerre C, Charreau I, Cua E, Rojas Castro D, Raffi F, Chas J, Huleux T, Spire B, Capitant C, Cotte L, Meyer L, Molina JM; ANRS IPERGAY study group. On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. Lancet HIV. 2020 Feb;7(2):e113-e120. doi: 10.1016/S2352-3018(19)30341-8. Epub 2019 Nov 26.
PubMed 31784343Schaefer R, Schmidt HA, Ravasi G, Mozalevskis A, Rewari BB, Lule F, Yeboue K, Brink A, Mangadan Konath N, Sharma M, Seguy N, Hermez J, Alaama AS, Ishikawa N, Dongmo Nguimfack B, Low-Beer D, Baggaley R, Dalal S. Adoption of guidelines on and use of oral pre-exposure prophylaxis: a global summary and forecasting study. Lancet HIV. 2021 Aug;8(8):e502-e510. doi: 10.1016/S2352-3018(21)00127-2. Epub 2021 Jul 12.
PubMed 34265283Reitsema M, Hoek AJV, van der Loeff MS, Hoornenborg E, van Sighem A, Wallinga J, van Benthem B, Xiridou M. Preexposure prophylaxis for men who have sex with men in the Netherlands: impact on HIV and Neisseria gonorrhoeae transmission and cost-effectiveness. AIDS. 2020 Mar 15;34(4):621-630. doi: 10.1097/QAD.0000000000002469.
PubMed 31895142Iniesta C, Coll P, Barbera MJ, Garcia Deltoro M, Camino X, Fagundez G, Diaz A, Polo R; Spanish Working Group for PrEP. Implementation of pre-exposure prophylaxis programme in Spain. Feasibility of four different delivery models. PLoS One. 2021 Feb 8;16(2):e0246129. doi: 10.1371/journal.pone.0246129. eCollection 2021.
PubMed 33556085Maxwell S, Shahmanesh M, Gafos M. Chemsex behaviours among men who have sex with men: A systematic review of the literature. Int J Drug Policy. 2019 Jan;63:74-89. doi: 10.1016/j.drugpo.2018.11.014. Epub 2018 Dec 1.
PubMed 30513473Guerras JM, Hoyos Miller J, Agusti C, Chanos S, Pichon F, Kuske M, Cigan B, Fuertes R, Stefanescu R, Ooms L, Casabona J, de la Fuente L, Belza MJ; Euro HIV EDAT Working Group. Association of Sexualized Drug Use Patterns with HIV/STI Transmission Risk in an Internet Sample of Men Who Have Sex with Men from Seven European Countries. Arch Sex Behav. 2021 Feb;50(2):461-477. doi: 10.1007/s10508-020-01801-z. Epub 2020 Sep 2.
PubMed 32875382Ambrosioni J, Petit E, Liegeon G, Laguno M, Miro JM. Primary HIV-1 infection in users of pre-exposure prophylaxis. Lancet HIV. 2021 Mar;8(3):e166-e174. doi: 10.1016/S2352-3018(20)30271-X. Epub 2020 Dec 11.
PubMed 33316212Adams JL, Shelley K, Nicol MR. Review of Real-World Implementation Data on Emtricitabine-Tenofovir Disoproxil Fumarate as HIV Pre-exposure Prophylaxis in the United States. Pharmacotherapy. 2019 Apr;39(4):486-500. doi: 10.1002/phar.2240. Epub 2019 Apr 1.
PubMed 30815960
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Clinical Benefits and Drawbacks of Antiretroviral Drugs as Pre-exposure Prophylaxis to Prevent HIV Infection Under Real-life Conditions Among Persons Who Pursue High-risk Sexual Practices: The Seville HIV PrEP Cohort
- ClinicalTrials.gov ID
- NCT05492565
- Acronym / sponsor ID
- SeVIHPrEP / SeVIHPrEP Cohort
- Conditions
- HIV Infection Primary, Hepatitis, Viral, Human, Sexually Transmitted Infections, Excluding HIV and Hepatitis
- Keywords
- PrEP, tenofovir disoproxyl fumarate, emtricitabine, HIV, Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Collaborators
- Instituto de Biomedicina de Sevilla
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pre-exposure prophylaxis (PrEP) based on tenofovir represents a considerably new preventive intervention that has shown to significantly decrease the number of HIV infections while it enables early diagnosis of HIV and other sexually transmitted diseases (STI).
In Southern Spain, the target population to receive PrEP are men who have sex with men (MSM) with a history of STI and who pursue high-risk sexual practices regarding the acquisition of HIV, including an elevate number of sex partners, no or inconsistent condom use and the use of specific recreational drugs in the context of sexual activity ("chemsex").
Despite the benefits of PrEP use, it must be taken into consideration that risk compensations that may facilitate the acquisition of other STI may occur, including a higher implementation of risk practices and an increase in the number of partners, which is made easy as various social networks designed for this purpose are available nowadays.
In order to better understand the benefit/drawback ratio, accurate data of a population using PrEP under real-life conditions, with densely scheduled follow-up and well-characterized (socio-)demographic parameters, sexual behaviour and STI are warranted.
Detailed description
To date, the availability of highly-active antiretroviral drugs enables an efficient and persistent suppression of HIV replication. This, on the one hand, results in a considerably higher life expectancy and quality of life among persons living with HIV (PLWH) and, on the other hand, reduces the risk of viral transmission. Based on these advances, the Joint United Nations Programme on HIV/AIDS (UNAIDS) has developed strategies aiming to end the HIV/AIDS epidemic by including preventive tools. With the aim to prevent the acquisition of HIV infection, recommendations for the use of post-exposure prophylaxis were established, however, this strategy requires both the awareness of having been exposed to the virus, as well as the access to treatment within 72 hours after exposure, which represents important limitations when put into practice. To overcome these obstacles, pre-exposure prophylaxis has been implemented during the last decade.
PrEP represents a preventive intervention that has demonstrated a significant decrease in HIV infections in a large number of randomized clinical trials and observational studies among various populations. Apart from the preventive benefits, it furthermore supports the early diagnosis of HIV and other sexually transmitted diseases (STI), leading to the World Health Organisation (WHO) to recommend its use in 2012. As a result of a complex analysis including efficacy, risks and costs, PrEP was only recommended for persons at substantial risk to get infected. Main representatives are men who have sex with men (MSM), in whom a decrease of 44%-86% in HIV infection in pilot clinical trials was observed, as well as transgender women and persons with an HIV-positive partner. Among those compliant to daily PrEP, infection rates become close to zero. Although the majority of the guidelines are based on this modality, there is evidence that MSM showing less frequent sexual activity could also benefit from on-demand PrEP. In comparison with daily PrEP, the on-demand modality encourages adherence due to its contemporaneous use with the sexual intercourse.
So far, the WHO recommendations have been adapted in clinical guidelines of more than 60% of the countries worldwide, showing an increasing trend and promising results, as reported from ongoing PrEP programmes. In Spain, the use of PrEP based on tenofovir (TNF) and emtricitabine has demonstrated its benefit in a study to evaluate PrEP implementation in four Spanish settings. Subsequently, the Interministerial Commission for Medical Costs of the Spanish government approved financial support for PrEP in specific risk groups for HIV acquisition as defined by the National AIDS Plan (Plan Nacional sobre el SIDA, PNS) and since September of 2019, PrEP represents an integral part of the Andalusian Health System services. In this context, PrEP is offered as complementary preventive tool included in a package aimed to raise awareness in persons at high risk for HIV infection in order to break the chain of transmission and warrant required health care. Thus, in the setting of Seville, Andalusia (Spain), the main candidates to receive PrEP are MSM with a history of STI and high-risk sexual behaviour, including an elevated number of sex partners, no or rare use of condoms and chemsex. The latter refers to a relatively new trend in the MSM community and describes the use of specific recreational drugs, mainly metamphetamine, mephedrone, poppers or gammahydroxybutyrate (GHB)/gammabutyrolactone (GBL) in any combination or route of administration, in the context of sexual activity with one, but often multiple partners. Chemsex is associated with high-risk sex practices and the acquisition of STI.
Despite the high interest in this preventive tool, real-life data on PrEP use are scarce, the sexual habits among its users are not well characterised and there is no information available for Andalusia, and especially the region of Seville, where the number of candidates for PrEP is estimated to exceed 1000 according to the Andalusian Plan against HIV/AIDS and other STI (Plan Andaluz frente al VIH/SIDA y otras ITS, PASIDA). Likewise, while the of primary HIV infections during PrEP are likely rare-to-absent, they cannot be excluded and their characteristics and clinical management are poorly studied. Additionally, in spite of the benefit of PrEP, there are various considerations regarding its use, like the development of adverse events on the short or long term in healthy people taking antiretroviral drugs, as in the case of TNF, renal function and bone density may be affected. Another major concern is the possibility of risk compensation in persons who feel less vulnerable due to the protective effect of PrEP. This could be manifested in a shift of sexual habits towards high-risk behaviour and/or an increase in the number of sex partners which can be achieved comfortably while remaining anonymous, given the social networks designed for this purpose available nowadays. Consequently, transmission of other STI, unintended pregnancies and resistance to TNF in case of primary HIV infection would be encouraged. Studies under real-life conditions including frequent and detailed monitoring are strongly needed in order to gain knowledge on the possible impact of PrEP on its users, taking into account possible changes in life style caused by the constant evolution of society and social media, like dating applications. In fact, a change in the social profile of MSM newly diagnosed with HIV infection has been reported recently in Madrid, which supports the need to improve the characterization and motorization of those participating in PrEP programmes.
In order to clarify this issue, accurate data of a population using PrEP under real-life conditions, with densely scheduled follow-up and well-characterized (socio-)demographic parameters, sexual behaviour and STI are warranted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Men who have sex with men | – | Drug: Tenofovir Disoproxil Fumarate 300 MG Oral TabletMen who have sex with men at substantial risk for HIV infection due to high-risk sexual habits |
| Transgender women | – | Drug: Tenofovir Disoproxil Fumarate 300 MG Oral TabletTransgender women at substantial risk for HIV infection due to high-risk sexual habits |
| Sex workers | – | Drug: Tenofovir Disoproxil Fumarate 300 MG Oral TabletSex workers at substantial risk for HIV infection due to high-risk sexual habits |
| HIV-uninfected people at substantial risk for HIV infection (other) | – | Drug: Tenofovir Disoproxil Fumarate 300 MG Oral TabletAll HIV-uninfected people at substantial risk for HIV infection due to any other reason, including having an HIV-positive life partnerwith an HIV-positive life partner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants of the SeVIHPrEP cohort are recruited from the candidates for a PrEP programme derived from the outpatient STI clinic at the Clinical Unit of Infecious Diseases and Preventive Medicine (Unidad Clínica de Enfermedades Infecciosas y Medicina Preventiva, UCEIMP) of the Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío) in Seville, Spain. Candidates are informed about the SeVIHPrEP protocol, an information sheet is handed out and additionally, the study is explained by the physician. They are then invited to participate in the cohort and upon acceptance, are asked to sign a written informed consent.
Key inclusion criteria (11 listed)
- HIV negative as demonstrated by negative HIV serology as determined by EIA and Western-Blot.
- Older than 18 years.
- At high risk of acquiring HIV infection by sexual transmission.
- MSM and transsexual persons who met at least two of the following criteria during the year prior to visit:
- More than ten different sexual partners.
Key exclusion criteria (3 listed)
- Glomerular filtration rate <60 ml/min.
- For on-demand PrEP: diagnosis of chronic hepatitis B.
- Allergic to TDF and/or FTC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir Disoproxil Fumarate 300 MG Oral TabletAlso: Emtricitabine 200 MG Oral TabletPre-exposure prophylaxis with coformulated Tenofovir Disoproxil Fumarate 300mg/Emtricitabine 200mg oral QD to prevent HIV infection | Drug | HIV-uninfected people at substantial risk for HIV infection (other), Men who have sex with men, Sex workers, Transgender women |
Primary outcome
Change from baseline proportion of PrEP users with STI-4c at one year
Time frame: Baseline through one year
Analysis of a change in the proportion of persons that present with infection by at least one of the following four common sexually transmitted pathogens (STI-4c): Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis and/or Mycoplasma genitalium.
Incidence of primary HIV infection
Time frame: Through study completion (an average 3 years)
Determination of the incidence of primary HIV infections during PrEP use
8 secondary outcomes
Proportion of PrEP users with STI other than STI-4c or HIV
Time frame: Through study completion (an average 3 years)
Number of STI
Time frame: Through study completion (an average 3 years)
Incidences of STI other than HIV
Time frame: Through study completion (an average 3 years)
Sexual behaviour
Time frame: Through study completion (an average 3 years)
Adverse events
Time frame: Through study completion (an average 3 years)
Adherence to PrEP
Time frame: Through study completion (an average 3 years)
Predictors of the incidence of HIV and other STI
Time frame: Through study completion (an average 3 years)
Predictors of a change in the proportion of STI-4c
Time frame: Baseline through one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 20537376Donnell D, Baeten JM, Kiarie J, Thomas KK, Stevens W, Cohen CR, McIntyre J, Lingappa JR, Celum C; Partners in Prevention HSV/HIV Transmission Study Team. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet. 2010 Jun 12;375(9731):2092-8. doi: 10.1016/S0140-6736(10)60705-2. Epub 2010 May 26.
- Background: PubMed 27424812Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR; HPTN 052 Study Team. Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med. 2016 Sep 1;375(9):830-9. doi: 10.1056/NEJMoa1600693. Epub 2016 Jul 18.
- Background: PubMed 15660015Smith DK, Grohskopf LA, Black RJ, Auerbach JD, Veronese F, Struble KA, Cheever L, Johnson M, Paxton LA, Onorato IM, Greenberg AE; U.S. Department of Health and Human Services. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep. 2005 Jan 21;54(RR-2):1-20.
- Background: PubMed 26598776Guideline on When to Start Antiretroviral Therapy and on Pre-Exposure Prophylaxis for HIV. Geneva: World Health Organization; 2015 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK327115/
- Background: PubMed 26624850Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, Tremblay C, Le Gall JM, Cua E, Pasquet A, Raffi F, Pintado C, Chidiac C, Chas J, Charbonneau P, Delaugerre C, Suzan-Monti M, Loze B, Fonsart J, Peytavin G, Cheret A, Timsit J, Girard G, Lorente N, Preau M, Rooney JF, Wainberg MA, Thompson D, Rozenbaum W, Dore V, Marchand L, Simon MC, Etien N, Aboulker JP, Meyer L, Delfraissy JF; ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015 Dec 3;373(23):2237-46. doi: 10.1056/NEJMoa1506273. Epub 2015 Dec 1.
- Background: PubMed 21091279Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.
- Background: PubMed 26471511Spinner CD, Boesecke C, Zink A, Jessen H, Stellbrink HJ, Rockstroh JK, Esser S. HIV pre-exposure prophylaxis (PrEP): a review of current knowledge of oral systemic HIV PrEP in humans. Infection. 2016 Apr;44(2):151-8. doi: 10.1007/s15010-015-0850-2. Epub 2015 Oct 15.
- Background: PubMed 31784343Antoni G, Tremblay C, Delaugerre C, Charreau I, Cua E, Rojas Castro D, Raffi F, Chas J, Huleux T, Spire B, Capitant C, Cotte L, Meyer L, Molina JM; ANRS IPERGAY study group. On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. Lancet HIV. 2020 Feb;7(2):e113-e120. doi: 10.1016/S2352-3018(19)30341-8. Epub 2019 Nov 26.
- Background: PubMed 34265283Schaefer R, Schmidt HA, Ravasi G, Mozalevskis A, Rewari BB, Lule F, Yeboue K, Brink A, Mangadan Konath N, Sharma M, Seguy N, Hermez J, Alaama AS, Ishikawa N, Dongmo Nguimfack B, Low-Beer D, Baggaley R, Dalal S. Adoption of guidelines on and use of oral pre-exposure prophylaxis: a global summary and forecasting study. Lancet HIV. 2021 Aug;8(8):e502-e510. doi: 10.1016/S2352-3018(21)00127-2. Epub 2021 Jul 12.
- Background: PubMed 31895142Reitsema M, Hoek AJV, van der Loeff MS, Hoornenborg E, van Sighem A, Wallinga J, van Benthem B, Xiridou M. Preexposure prophylaxis for men who have sex with men in the Netherlands: impact on HIV and Neisseria gonorrhoeae transmission and cost-effectiveness. AIDS. 2020 Mar 15;34(4):621-630. doi: 10.1097/QAD.0000000000002469.
- Background: PubMed 33556085Iniesta C, Coll P, Barbera MJ, Garcia Deltoro M, Camino X, Fagundez G, Diaz A, Polo R; Spanish Working Group for PrEP. Implementation of pre-exposure prophylaxis programme in Spain. Feasibility of four different delivery models. PLoS One. 2021 Feb 8;16(2):e0246129. doi: 10.1371/journal.pone.0246129. eCollection 2021.
- Background: PubMed 30513473Maxwell S, Shahmanesh M, Gafos M. Chemsex behaviours among men who have sex with men: A systematic review of the literature. Int J Drug Policy. 2019 Jan;63:74-89. doi: 10.1016/j.drugpo.2018.11.014. Epub 2018 Dec 1.
- United Nations Programme on HIV/AIDS 2020. 90-90-90: An ambitious treatment target to help end the AIDS epidemic. 2019Link provided by the sponsor.
- Ministerio de Sanidad Servicios Sociales e Igualdad. Documento de consenso. Profilaxis Preexposición al VIH en España. Plan Nacional sobre el Sida. Published Online First: 2018Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karin Neukam, PharmD, PhD study director
Instituto de Biomedicina de Sevilla/ H Universitario Virgen del Rocío/ CSIC/ Universidad de Sevilla
César Sotomayor de la Piedra, MD principal investigator
Hospitales Universitarios Virgen del Rocío
Marta Herrero Romero, MD, PhD principal investigator
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection Primary and Hepatitis, Viral, Human, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline proportion of PrEP users with STI-4c at one year (time frame: Baseline through one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05492565, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.