A Cluster Randomized Trial of Integrated Care Centers to Improve Access to HIV Prevention, Testing, and Treatment Services Among High-Risk Vulnerable Populations in India
Integrated care centers
Blood-Borne Infections+19
+ Urogenital Diseases
+ Genital Diseases
Services Research Study
Summary
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.21726 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Key Informant Interviews: Persons may be included in the key informant interviews if they meet all of the following criteria: 18 years of age or older Knowledge of the local HIV risk group of interest (IDU or MSM) Psychologically fit to participate in the study and to understand the consent Ability to comprehend one of the consent translation languages Provide informed consent Focus groups: Persons may be included in the focus groups if they meet all of the following criteria: 18 years of age or older Member of a target HIV risk group, meeting criterion 2a or 2b IDU: self-reported injection drug use in prior 12 months MSM: self-identify as male and report oral/anal sex with another male in prior 12 months Psychologically fit to participate in the study and to understand the consent Ability to comprehend one of the consent translation languages Provide informed consent Baseline or evaluation respondent-driven sampling (RDS) survey Persons may be included in the baseline or evaluation RDS survey if they meet all of the following criteria: 18 years of age or older Member of a target HIV risk group, meeting criterion 2a or 2b IDU: self-reported injection drug use in prior 24 months MSM: self-identify as male and report oral/anal sex with another male in prior 12 months Psychologically fit to participate in the study and to understand the consent Ability to comprehend one of the consent translation languages Present a valid RDS referral coupon (unless a seed) Provide informed consent Exclusion Criteria: Key Informant Interviews: Persons will be excluded from the key informant interviews if they meet any of the following criteria: Younger than 18 years Do not have knowledge of the local HIV risk group of interest (IDU or MSM) Are not psychologically fit to participate in the study or to understand the consent Do not have ability to comprehend one of the consent translation languages Do not provide informed consent Focus groups: Persons will be excluded from the focus groups if they meet any of the following criteria: Younger than 18 years Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b IDU: self-reported injection drug use in prior 12 months MSM: self-identify as male and report oral/anal sex with another male in prior 12 months Are not psychologically fit to participate in the study or to understand the consent Do not have ability to comprehend one of the consent translation languages Do not provide informed consent Baseline or evaluation RDS survey Persons will be excluded in the baseline or evaluation RDS survey if they meet any of the following criteria: Younger than 18 years Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b IDU: self-reported injection drug use in prior 24 months MSM: self-identify as male and report oral/anal sex with another male in prior 12 months Are not psychologically fit to participate in the study or to understand the consent Do not have ability to comprehend one of the consent translation languages Do not present a valid RDS referral coupon and are not a seed Do not provide informed consent
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
YR Gaitonde Center for AIDS Research and Education
Chennai, IndiaOpen YR Gaitonde Center for AIDS Research and Education in Google Maps