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Completed

NCT Number: NCT01686750

Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

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.

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Key information

Conditions

HIV Infection Behavior Blood-Borne Infections Communicable Diseases Disease Attributes Genital Diseases HIV Infections Homosexuality Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Risk Reduction Behavior Sexual Behavior Sexuality Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YR Gaitonde Center for AIDS Research and Education

Chennai, Tamil Nadu, 600113, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • IDU: self-reported injection drug use in prior 12 months
  • 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
  • IDU: self-reported injection drug use in prior 24 months
  • 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
  • IDU: self-reported injection drug use in prior 12 months
  • 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
  • IDU: self-reported injection drug use in prior 24 months
  • 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

Treatment and study plan

Integrated Care Centers

Behavioral

Primary outcomes

  1. Proportion Reporting HIV Testing in the Prior 12 Months

    Time frame: 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 outcomes

  1. Proportion of HIV-infected Participants Aware of Status

    Time frame: 2 years

    Proportion of HIV-positive participants that were aware of their status at the time of the visit

  2. Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months

    Time frame: 2 years

  3. Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy

    Time frame: 2 years

  4. Community Viral Load

    Time frame: 2 years

    Average log(10) HIV RNA concentration among HIV-infected participants

  5. Proportion of HIV-infected Participants With Suppressed HIV RNA

    Time frame: 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)

  6. Prevalence of Recent HIV Infection

    Time frame: 2 years

  7. Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months

    Time frame: 2 years

  8. Proportion of IDU Reporting Drug Abstinence in Prior 6 Months

    Time frame: 2 years

  9. Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months

    Time frame: 2 years

  10. Number of Non-main Male Partners in Prior 6 Months in MSM

    Time frame: 2 years

  11. Proportion Reporting Substance Abuse Among MSM

    Time frame: 2 years

  12. Proportion With Depressive Symptoms

    Time frame: 2 years

    Participants with Score >=10 on Patient Health Questionnaire-9

  13. Number of Unprotected Sexual Acts Reported by MSM

    Time frame: 2 years

  14. Vicarious Stigma as Assessed by 6-item Stigma Scale

    Time frame: 2 years

    Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma

  15. Proportion Reporting Spouse Ever Tested for HIV

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Elton John AIDS Foundation
  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)
  • YR Gaitonde Centre for AIDS Research and Education

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 18, 2012
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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