Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

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

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.

Inclusion Criteria:

Key Informant Interviews:

Persons may be included in the key informant interviews if they meet all of the following criteria:

1. 18 years of age or older
2. Knowledge of the local HIV risk group of interest (IDU or MSM)
3. Psychologically fit to participate in the study and to understand the consent
4. Ability to comprehend one of the consent translation languages
5. Provide informed consent

Focus groups:

Persons may be included in the focus groups if they meet all of the following criteria:

1. 18 years of age or older

2. Member of a target HIV risk group, meeting criterion 2a or 2b

   1. IDU: self-reported injection drug use in prior 12 months
   2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months

3. Psychologically fit to participate in the study and to understand the consent

4. Ability to comprehend one of the consent translation languages

5. 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:

1. 18 years of age or older

2. Member of a target HIV risk group, meeting criterion 2a or 2b

   1. IDU: self-reported injection drug use in prior 24 months
   2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months

3. Psychologically fit to participate in the study and to understand the consent

4. Ability to comprehend one of the consent translation languages

5. Present a valid RDS referral coupon (unless a seed)

6. 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:

1. Younger than 18 years
2. Do not have knowledge of the local HIV risk group of interest (IDU or MSM)
3. Are not psychologically fit to participate in the study or to understand the consent
4. Do not have ability to comprehend one of the consent translation languages
5. Do not provide informed consent

Focus groups:

Persons will be excluded from the focus groups if they meet any of the following criteria:

1. Younger than 18 years

2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b

   1. IDU: self-reported injection drug use in prior 12 months
   2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months

3. Are not psychologically fit to participate in the study or to understand the consent

4. Do not have ability to comprehend one of the consent translation languages

5. 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:

1. Younger than 18 years

2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b

   1. IDU: self-reported injection drug use in prior 24 months
   2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months

3. Are not psychologically fit to participate in the study or to understand the consent

4. Do not have ability to comprehend one of the consent translation languages

5. Do not present a valid RDS referral coupon and are not a seed

6. Do not provide informed consent