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Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

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ClinicalTrials.gov Identifier: NCT01686750
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : March 21, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
YR Gaitonde Centre for AIDS Research and Education
Elton John AIDS Foundation
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infection Behavioral: Integrated care centers Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : October 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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 & 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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion reporting HIV testing in the prior 12 months [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]

Secondary Outcome Measures :
  1. Proportion of HIV-infected participants aware of status [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  2. 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 ]
  3. Proportion of antiretroviral therapy-eligible HIV-infected participants using antiretroviral therapy [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  4. Community viral load [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
    Average log(10) HIV RNA concentration among HIV-infected participants

  5. Proportion of HIV-infected participants with suppressed HIV RNA [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  6. Prevalence of recent HIV infection [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  7. Proportion of IDU reporting needle or syringe sharing [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  8. Proportion of IDU reporting drug abstinence [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  9. Proportion reporting unprotected vaginal/anal intercourse [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  10. Number of non-main male partners in prior 6 months in MSM [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  11. Proportion reporting substance abuse among MSM [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  12. Proportion with depressive symptoms [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  13. Number of unprotected sexual acts reported by MSM [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  14. Perceived and experienced stigma [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  15. Proportion reporting spouse tested for HIV [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686750


Locations
India
YR Gaitonde Center for AIDS Research and Education
Chennai, Tamil Nadu, India, 600113
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
Elton John AIDS Foundation
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 Centre for AIDS Research and Education
Principal Investigator: Aylur Srikrishnan, BA YR Gaitonde Centre for AIDS Research and Education
Principal Investigator: Suresh Kumar, MPH YR Gaitonde Centre for AIDS Research and Education
Principal Investigator: Sunil S Solomon, PhD Johns Hopkins University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01686750     History of Changes
Other Study ID Numbers: NA_00047702
R01DA032059 ( U.S. NIH Grant/Contract )
R01MH089266 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases