HIV prevention
Conditions
Interventions
Trade Name: Truvada
Pharmaceutical Form: Film-coated tablet
Sponsors
Institute of Tropical Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Able and willing to provide written informed consent 2) Born to male sex and age of 18 years or more (including transgender females) 3) Had sex with a man in the last 12 months 4) HIV negative (confirmed at enrollment) 5) At least one criterion for “High Risk”: - Reported unprotected (= condomless) anal intercourse (UAI) in the last six months with a casual partner (with unknown HIV status or HIV positive status)) - Reported STI episode in the last six months - Taken PEP in the last six months 6) Able and willing to participate in the study as required by the protocol for 18 months 7) Motivation to strengthen their own prevention efforts, including interest in starting/consider to use PrEP Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Having symptoms/clinical signs consistent with acute HIV infection1 (AHI) 2) Being allergic to the active substances or any of the excipients. 3) Having an estimated creatinine clearance of < 60 mL/minute according to the Modification of Diet in Renal Disease (MDRD) formula 4) Having an active Hepatitis B infection (see table 1 for different scenario’s) 5) Taking HIV PEP, medicinal products containing emtricitabine, tenofovir disoproxil or other cytidine analogues (such as lamivudine), adefovir dipivoxil. 6) Participating in other clinical studies (phase I-III) or another research study related to HIV/ARV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Among MSM at high risk for acquiring HIV: - To document their current preventive needs, including the uptake, acceptability and feasibility of using PrEP intermittently or daily - To evaluate adherence to two different PrEP regimens;Secondary Objective: - To study the impact of PrEP use on other preventive strategies such as condom use - To study the impact of PrEP use on STI trends - To study the safety of daily and intermittent use of PrEP - To document “real life effectiveness” of PrEP use on HIV seroconversion, and treatment related resistance - To evaluate the feasibility of three monthly HIV testing using oral fluid self-sampling testing;Primary end point(s): - Recruitment rate - (Un)safe sex behaviour during the last 6 months - % reported intention to use PrEP - Retention rates in the different regimens - Subjective attitudes to PrEP use: motivation, satisfaction - Adherence to 1) one pill Truvada a day or 2) intermittent use: 1) (In)consistent pill take 2) % days with no pill take/days on which a pill should have been taken 3) Tenofovir drug levels in blood and/or hair samples 3) Perceived skills to adhere, including self-efficacy;Timepoint(s) of evaluation of this end point: The analyses of the primary end points are planned to be completed 2 years after the last participant visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of sex partners - self-reported condom use - sex under influence (alcohol, drugs) - STI incidence: CT/NG, MG/TV (if funding permits), HSV-2, syphilis and Hepatitis C - Rate of adverse events related to PrEP - Incidence of HIV infection among the study population by regimen - Genotypic viral resistance among HIV seroconvertors - Feasibility of oral fluid self-sampling testing;Timepoint(s) of evaluation of this end point: The analyses of the primary end points are planned to be completed 2 years after the last participant visit. | — |
Countries
Belgium
Contacts
Public ContactClinical Trials Unit
Institute of Tropical Medicine
Outcome results
None listed