This is a cluster randomized trial to evaluate the effectiveness of integrated care centers (ICC) to improve access to HIV testing, prevention services, and treatment among high-risk populations of injection drug users (IDU) and men who have sex with men (MSM) in India. We will collect baseline ethnographic and survey data from approximately 27 IDU or MSM sites in India. We will use baseline data to select 22 sites for the trial (12 IDU and 10 MSM) and to stratify sites according to key baseline characteristics. We will perform stratified randomization to assign sites to either the ICC intervention or to standard services. ICCs, which will be either IDU or MSM-focused, will provide an accepting atmosphere in which members of vulnerable groups can drop-in, receive rapid HIV voluntary counselling and testing, risk reduction counseling and services, and antiretroviral therapy. ICCs will be scaled-up from existing governmental or non-governmental organizations and services provided at ICCs will be supported by the National AIDS Control Organization (NACO) of India. After providing services in communities for two years, we will conduct an evaluation survey (with biological and behavioral measures) of approximately 1000 subjects in the target populations in each of the 22 study sites. Integrated care centers have the potential to improve access to HIV prevention and treatment services among vulnerable, high-risk populations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
21,726
YR Gaitonde Center for AIDS Research and Education
Chennai, Tamil Nadu, India
Proportion Reporting HIV Testing in the Prior 12 Months
Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.
Time frame: 2 years
Proportion of HIV-infected Participants Aware of Status
Proportion of HIV-positive participants that were aware of their status at the time of the visit
Time frame: 2 years
Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months
Time frame: 2 years
Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy
Time frame: 2 years
Community Viral Load
Average log(10) HIV RNA concentration among HIV-infected participants
Time frame: 2 years
Proportion of HIV-infected Participants With Suppressed HIV RNA
Proportion of HIV-positive participants meeting criteria for antiretroviral therapy \[cluster of differentiation 4 (CD4) count \<350 cells/mm3 or current or past use of antiretroviral therapy)\] who have a suppressed viral load (HIV RNA \<150 copies/mL)
Time frame: 2 years
Prevalence of Recent HIV Infection
Time frame: 2 years
Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months
Time frame: 2 years
Proportion of IDU Reporting Drug Abstinence in Prior 6 Months
Time frame: 2 years
Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months
Time frame: 2 years
Number of Non-main Male Partners in Prior 6 Months in MSM
Time frame: 2 years
Proportion Reporting Substance Abuse Among MSM
Time frame: 2 years
Proportion With Depressive Symptoms
Participants with Score \>=10 on Patient Health Questionnaire-9
Time frame: 2 years
Number of Unprotected Sexual Acts Reported by MSM
Time frame: 2 years
Vicarious Stigma as Assessed by 6-item Stigma Scale
Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma
Time frame: 2 years
Proportion Reporting Spouse Ever Tested for HIV
Time frame: 2 years
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