incidence of human immunodeficiency virus-1 (hiv-1) infection in hiv-1 uninfected high risk men who have sex with men

Conditions: Infection, Human Immunodeficiency Virus; HIV Infections

Summary: studies to assess the effectiveness of interventions to prevent hiv infection depend upon robust estimates of baseline hiv incidence rates. the changing landscape of high-risk populations, as well as the evolution of biomedical pre-exposure prophylaxis (prep) interventions, requires a contemporary evaluation of hiv incidence as well as demographic, behavioral and other subject factors which may impact hiv incidence. this is a prospective cohort study to measure hiv-1 seroincidence in a study population of hiv-1 uninfected chinese men who have sex with men (msm) and transgender women (tgw) who are at high-risk of hiv infection. approximately 550 subjects who are male sex at birth and have sex with men shall enter the study, which will allow for a 10% drop out rate to maintain 500 subjects at the conclusion of the cohort. this is a single arm cohort study to determine hiv-1 seroincidence rates in high risk msm and tgw when combined with a comprehensive prevention package including hiv and safe sex counseling, provision of condoms and water-based lubricant, and sexually transmitted infection (sti) screening and referral for treatment. it will be determined what proportion of high-risk msm and tgw who are given a comprehensive hiv-1 prevention package will acquire hiv-1 infection.


Eligibility criteria:
inclusion criteria: * subjects are chinese msm and/or tgw and must be 18 years or older at the time of screening. * subjects of male sex at birth and who have sex with men, who in the 6 months prior to screening report one or more of the following risk criteria: * unprotected (condomless) receptive anal intercourse with one or more partners. * more than five partners in the 6 months prior to enrolment (regardless of condom use and hiv serostatus, as reported by the enrolee). * reported sti with syphilis, gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum. subjects in a monogamous relationship with an hiv-1 seronegative partner or a virologically-suppressed hiv-1 + partner for \>1 year are not eligible for participation. * males, agree to appropriate use of contraceptive measures during heterosexual intercourse. * subjects who have non reactive fourth generation hiv test and undetectable hiv-1 rna at screening. * capable of giving signed informed consent. exclusion criteria: * subjects with known moderate to severe hepatic impairment as per liver function test criteria outlined below. * subject who, in the investigator's judgment, poses a significant suicide risk. * the subject has a tattoo or other dermatological condition overlying the gluteus region. * clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (cabg) surgery or percutaneous transluminal coronary angioplasty (ptca) or any clinically significant cardiac disease. * use of prep or post exposure prophylaxis (pep) within the last 30 days prior to screening. * current use or anticipated need for use high dose aspirin or other anticoagulants including antiplatelet medications that would interfere with the ability to receive intramuscular (im) injections. * exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the screening. * anti-tuberculosis therapy. * alcohol use that in the judgment of the investigator would interfere with the subject's ability to complete study procedures. * active injection drug use that in the judgment of the investigator would interfere with the subject's ability to complete study procedures. * any medical condition, including psychiatric conditions, that in the judgment of the investigator would interfere with the subject's ability to complete study procedures. * a reactive hiv test at screening. * a positive hepatitis b surface antigen. * a positive hepatitis c antibody with an hcv viral ribose nucleic acid (rna) above the lower limit of detection. * any of the following laboratory values at screening: * hemoglobin (hgb) \<11 gram per deciliter (g/dl). * absolute neutrophil count \<750 cells per cubic millimeter (cells/mm\^3). * platelet count \<100,000 cells/mm\^3. * presence of a coagulopathy defined by an international normalized ratio (inr)\>1.5 or a partial thromboplastin time (ptt)\>45 seconds. * creatinine clearance \<60 milliliter per minute (ml/min) using the cockroft-gault equation. * aspartate aminotransferase (ast) \>1.5 times upper limit of normal (uln). * direct bilirubin \>2.0 milligram per deciliter (mg/dl). * co-enrolment in any other hiv interventional studies.

Keywords: prep msm seroincidence hiv-1 tgw stis