The first case of HIV infection in Georgia was identified in 1989. As of July 31, 2017 a total of 6,481 cases of HIV infection had been reported with the majority (74%, n=4,827) occurring in men. However, the estimated number of people living with HIV in Georgia is believed to be 11,500. Geographic proximity to the Russian Federation and Ukraine significantly contributed to the development of the HIV epidemic in Georgia. As in the rest of Eastern European and Central Asian (EECA) region, for many years injection drug use (IDU) has been a major driver of epidemic in the country, currently accounting for 44% of total cases reported. Trends in distribution of newly reported cases show decrease in the proportion of cases due to IDU, with increase in the proportion of homosexually acquired infections. Proportion of MSM among newly diagnosed HIV patients in Georgia increased from 3% in 2003 to 23% in 2017.

Repeated surveys conducted among MSM showed more than 6-fold increase in the prevalence from 4% in 2007 to 25% in 2015. Surveillance data shows more than 17-fold increase in the number of newly reported cases of HIV among MSM since 2005. Studies using recent infection testing algorithm (RITA) and phylogenetic analyses provide further evidence of the emerging epidemic among MSM.

In 2016 through the support of International Science and Technology Center (ISTC) the first in Eastern Europe cohort of MSM was established in Georgia (ISTC project # G-2216). This one-year pilot study confirmed previous findings of fast growing epidemic in MSM, with very high incidence of HIV - 5.8 new infections per 100 person-years (PY) of follow-up. However, short duration of follow-up of up to 12 months in project G-2216 limited studies ability to make long-term predictions and thus longer follow-up is required to better understand drivers of HIV epidemic in this population.

The long-term goal of the proposed study is to move obtained knowledge into effective strategies towards ending AIDS epidemic among MSM. Specific objectives and tasks include:

Objective 1: Prospectively evaluate epidemiology of HIV, viral hepatitis and syphilis among MSM and transgender persons

Task 5: Quantify engagement in care continuum of recently identified HIV infections

Three major novelties will be introduced in the proposed study, including: 1) long-term (36 months) follow-up; 2) inclusion of transgender persons, who are often missed from dedicated research and public health projects; 3) evaluation of molecular epidemiology of recently seroconverted cases.

A prospective cohort study design will be utilized to accomplish the proposed specific aims. For this purpose 500 MSM and 30 transgender persons will be enrolled (details on subject selection and recruitment are provided in the section 6 “Technical approach and methodology”).

The epidemiology of HIV among MSM in Georgia will be studied in a cohort of 500 MSM, of them 250 persons will be re-recruited from previous cohort study (G-2216) and 250 persons will be newly recruited in the cities of Tbilisi and Kutaisi. After informed consent, participants will undergo study procedures at recruitment and after 6 months. The procedures will include collection of blood specimens for laboratory testing on HIV, HCV, HBV and syphilis. Each participant will be interviewed at study visits to elicit information on risk factors using a structured questionnaire.

We will establish cohort of transgender persons which will be preceded by formative research among this sub-population in order to derive baseline information about risks, needs and about possible recruitment strategies.

We will quantify the engagement of newly identified HIV positive MSM in our study starting from HIV diagnosis through virologic suppression. For this purpose we will use clinical data from the National AIDS Health Information System. The system comprises an electronic database containing comprehensive information on all reported cases of HIV infection in Georgia. In addition we will interview all persons positive for HCV, HBV and syphilis about accessing relevant clinical services.