Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV Infection

Intervention / Treatment
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* Behavioral: Integrated care centers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated care centers<br>Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. HIV voluntary counseling and testing & staging Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy Substance abuse counseling Sexually transmitted infection screening and treatment Access to free antiretroviral therapy and adherence support Peer community outreach | Behavioral: Integrated care centers<br> <br> |
| No Intervention: Standard services<br>In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 
| Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months |  | 2 years | 
| Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy |  | 2 years | 
| Community Viral Load | Average log(10) HIV RNA concentration among HIV-infected participants | 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) | 2 years | 
| Prevalence of Recent HIV Infection |  | 2 years | 
| Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months |  | 2 years | 
| Proportion of IDU Reporting Drug Abstinence in Prior 6 Months |  | 2 years | 
| Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months |  | 2 years | 
| Number of Non-main Male Partners in Prior 6 Months in MSM |  | 2 years | 
| Proportion Reporting Substance Abuse Among MSM |  | 2 years | 
| Proportion With Depressive Symptoms | Participants with Score >=10 on Patient Health Questionnaire-9 | 2 years | 
| Number of Unprotected Sexual Acts Reported by MSM |  | 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 | 2 years | 
| Proportion Reporting Spouse Ever Tested for HIV |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, injection drug use, men who have sex with men, voluntary counselling and testing, risk reduction, sexually transmitted infections, community viral load, antiretroviral therapy