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.
Study Type
OBSERVATIONAL
Enrollment
578
Subjects will receive comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and STI screening and referral for treatment.
Information regarding social harms (loss of privacy, stigmatization, interference with gainful employment, and coercion) will be solicited during bi-monthly study visits after enrollment in the study and will be recorded. Subjects who report social harms will be referred to speak with a social worker and/or a study counselor.
Demographic, behavioral, and psychosocial factors associated with HIV acquisition will be assessed by CASI.
GSK Investigational Site
Guangzhou, Guangdong, China
GSK Investigational Site
Shenyang, Liaoning, China
GSK Investigational Site
Chengdu, Sichuan, China
GSK Investigational Site
Hangzhou, Zhejiang, China
GSK Investigational Site
Beijing, China
GSK Investigational Site
Beijing, China
GSK Investigational Site
Changsha, China
GSK Investigational Site
Shanghai, China
GSK Investigational Site
Shenzhen, China
HIV-1 seroincidence rate in a cohort of high-risk MSM and TGW
Incidence of HIV-1 infection in subject's post-study entry will be assessed by determining number of subjects who become infected with HIV-1 post-screening and after study entry including Day 1 and subsequent observation visits. Confirmatory HIV serology test will be performed at seroconversion visit.
Time frame: Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
HIV-1 seroincidence rate in a cohort of high-risk TGW
Incidence of HIV-1 infection in subject's post-study entry will be assessed by determining number of subjects who become infected with HIV-1 post-screening and after study entry including Day 1 and subsequent observation visits. Confirmatory HIV serology test will be performed at seroconversion visit.
Time frame: Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
Number of subjects diagnosed with gonorrhea, chlamydia, and syphilis post screening
Infections like gonorrhea, chlamydia, and syphilis will be assessed by toluidine red unheated serum test (TRUST) for syphilis and STI testing.
Time frame: Day 1, Week 9, and every 16 weeks interval thereafter until study completion, an average of 12 months
Number of subjects with demographic factors
Demographic factors associated with HIV seroconversion and STI acquisition will be assessed by computer-assisted self-interview (CASI).
Time frame: Day 1, Week 9, and every 8 weeks interval thereafter until study completion, an average of 12 months
Number of subjects enrolled and retained in to the study
Measures will be utilized to effectively engage and retain the subjects in the study. Retention strategies to be studied may include community engagement, interpersonal relationship building and reduction of external barriers.
Time frame: Day 1, Weeks 5, 9, and every 8 or 16 weeks interval thereafter until study completion, an average of 12 months
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