Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Johns Hopkins University
Sponsor:
Collaborators:
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

September 13, 2012
November 22, 2012
October 2012
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT01686750 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
HIV Infection
Behavioral: Integrated care centers
  • 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
    Intervention: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
49000
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Shruti Mehta, PhD 443-287-3837 shmehta@jhsph.edu
India
 
NCT01686750
R01DA032059, R01DA032059, R01MH089266
Yes
Gregory M. Lucas, Johns Hopkins University
Johns Hopkins University
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
  • YR Gaitonde Centre for AIDS Research and Education
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
Johns Hopkins University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP