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Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

This study is currently recruiting participants.
Verified November 2012 by Johns Hopkins University
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
YR Gaitonde Centre for AIDS Research and Education
Information provided by (Responsible Party):
Gregory M. Lucas, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01686750
First received: September 13, 2012
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Infection
 Behavioral: Integrated care centers
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Proportion reporting HIV testing in the prior 12 months [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of HIV-infected participants aware of status [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Proportion of HIV-infected participants visiting an HIV treatment provider in prior 6 months [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Proportion of ART-eligible HIV-infected participants using ART [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Community viral load [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
    Average log(10) HIV RNA concentration among HIV-infected participants

  • Proportion of HIV-infected participants with suppressed HIV RNA [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Prevalence of recent HIV infection [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Proportion of IDU reporting needle or syringe sharing [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Proportion of IDU reporting drug abstinence [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Proportion reporting unprotected vaginal/anal intercourse [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Number of non-main male partners in prior 6 months in MSM [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Proportion reporting substance abuse among MSM [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Proportion with depressive symptoms [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Number of unprotected sexual acts reported by MSM [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Perceived and experienced stigma [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]
  • Proportion reporting spouse tested for HIV [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ] [ Designated as safety issue: No ]

Estimated Enrollment: 49000
Study Start Date: October 2012
Arms Assigned Interventions
Experimental: 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 & CD4 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
No Intervention: Standard services
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686750

Contacts
Contact: Shruti Mehta, PhD 443-287-3837 shmehta@jhsph.edu

Locations
India
YR Gaitonde Center for AIDS Research and Education Recruiting
Chennai, Tamil Nadu, India, 600113
Contact: Aylur Srikrishnan, BA     91+22542929     krish@yrgcare.org    
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
YR Gaitonde Centre for AIDS Research and Education
Investigators
Principal Investigator: Gregory M Lucas, MD Johns Hopkins University
Principal Investigator: Shruti Mehta, PhD Johns Hopkins University
Principal Investigator: David D Celentano, ScD Johns Hopkins University
Principal Investigator: Suniti Solomon, MD YR Gaitonde Center for AIDS Research and Education
Principal Investigator: Aylur Srikrishnan, BA YR Gaitonde Center for AIDS Research and Education
Principal Investigator: Suresh Kumar, MPH YR Gaitonde Center for AIDS Research and Education
Principal Investigator: Sunil S Solomon, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Gregory M. Lucas, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01686750     History of Changes
Other Study ID Numbers: R01DA032059, R01DA032059, R01MH089266
Study First Received: September 13, 2012
Last Updated: November 22, 2012
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board
India: Indian Council of Medical Research
India: Institutional Review Board
United States: Federal Government

Keywords provided by Johns Hopkins University:
HIV
injection drug use
men who have sex with men
voluntary counselling and testing
 risk reduction
sexually transmitted infections
community viral load
antiretroviral therapy

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on March 14, 2013