This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Gregory M. Lucas, 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
Elton John AIDS Foundation
Information provided by (Responsible Party):
Gregory M. Lucas, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01686750
First received: September 13, 2012
Last updated: March 3, 2017
Last verified: March 2017
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
Intervention Model: Parallel Assignment
Masking: No masking
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:

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

Further study details as provided by Gregory M. Lucas, 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 ]

Secondary Outcome Measures:
  • Proportion of HIV-infected participants aware of status [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  • 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 ]
  • Proportion of ART-eligible HIV-infected participants using ART [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  • Community viral load [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
    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 ]
  • Prevalence of recent HIV infection [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  • Proportion of IDU reporting needle or syringe sharing [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  • Proportion of IDU reporting drug abstinence [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  • Proportion reporting unprotected vaginal/anal intercourse [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  • Number of non-main male partners in prior 6 months in MSM [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  • Proportion reporting substance abuse among MSM [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  • Proportion with depressive symptoms [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  • Number of unprotected sexual acts reported by MSM [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  • Perceived and experienced stigma [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
  • Proportion reporting spouse tested for HIV [ Time Frame: Measured in Baseline and Evaluation (~ 2 years later) Surveys ]
Estimated Enrollment: 49000
Study Start Date: October 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

Publications:

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

Responsible Party: Gregory M. Lucas, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01686750     History of Changes
Other Study ID Numbers: R01DA032059 ( US NIH Grant/Contract Award Number )
R01MH089266 ( US NIH Grant/Contract Award Number )
Study First Received: September 13, 2012
Last Updated: March 3, 2017

Keywords provided by Gregory M. Lucas, 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

ClinicalTrials.gov processed this record on June 22, 2017