Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

Not Applicable

Completed

Conditions: HIV Infection

Interventions: Behavioral: Integrated care centers

Registration Number: NCT01686750

Lead Sponsor: Johns Hopkins University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21726

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
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
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
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
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
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
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
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
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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated care centers	Integrated care centers	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

Primary Outcome Measures

Name	Time	Method
Proportion Reporting HIV Testing in the Prior 12 Months	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months	2 years
Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months	2 years
Vicarious Stigma as Assessed by 6-item Stigma Scale	2 years	Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma
Proportion of HIV-infected Participants Aware of Status	2 years	Proportion of HIV-positive participants that were aware of their status at the time of the visit
Community Viral Load	2 years	Average log(10) HIV RNA concentration among HIV-infected participants
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
Prevalence of Recent HIV Infection	2 years
Proportion Reporting Spouse Ever Tested for HIV	2 years
Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy	2 years
Proportion of HIV-infected Participants With Suppressed HIV RNA	2 years	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)
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	2 years	Participants with Score \>=10 on Patient Health Questionnaire-9
Number of Unprotected Sexual Acts Reported by MSM	2 years