Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations - Full Text View

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:

MedlinePlus related topics: HIV/AIDS

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
Estimated Study Completion Date:	November 2016
Estimated Primary Completion Date:	November 2016 (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.

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)
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:

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
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
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
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
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
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
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
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
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

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:

Solomon SS, Mehta SH, Srikrishnan AK, Vasudevan CK, Mcfall AM, Balakrishnan P, Anand S, Nandagopal P, Ogburn EL, Laeyendecker O, Lucas GM, Solomon S, Celentano DD. High HIV prevalence and incidence among MSM across 12 cities in India. AIDS. 2015 Mar 27;29(6):723-31. doi: 10.1097/QAD.0000000000000602.

Lucas GM, Solomon SS, Srikrishnan AK, Agrawal A, Iqbal S, Laeyendecker O, McFall AM, Kumar MS, Ogburn EL, Celentano DD, Solomon S, Mehta SH. High HIV burden among people who inject drugs in 15 Indian cities. AIDS. 2015 Mar 13;29(5):619-28. doi: 10.1097/QAD.0000000000000592.

Solomon SS, Mehta SH, Srikrishnan AK, Solomon S, McFall AM, Laeyendecker O, Celentano DD, Iqbal SH, Anand S, Vasudevan CK, Saravanan S, Lucas GM, Kumar MS, Sulkowski MS, Quinn TC. Burden of hepatitis C virus disease and access to hepatitis C virus services in people who inject drugs in India: a cross-sectional study. Lancet Infect Dis. 2015 Jan;15(1):36-45. doi: 10.1016/S1473-3099(14)71045-X. Epub 2014 Dec 3.

Solomon SS, Lucas GM, Celentano DD, Sifakis F, Mehta SH. Beyond surveillance: a role for respondent-driven sampling in implementation science. Am J Epidemiol. 2013 Jul 15;178(2):260-7. doi: 10.1093/aje/kws432. Epub 2013 Jun 25.

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

Solomon SS, Mehta SH, McFall AM, Srikrishnan AK, Saravanan S, Laeyendecker O, Balakrishnan P, Celentano DD, Solomon S, Lucas GM. Community viral load, antiretroviral therapy coverage, and HIV incidence in India: a cross-sectional, comparative study. Lancet HIV. 2016 Apr;3(4):e183-90. doi: 10.1016/S2352-3018(16)00019-9. Epub 2016 Mar 11.

Mehta SH, Lucas GM, Solomon S, Srikrishnan AK, McFall AM, Dhingra N, Nandagopal P, Kumar MS, Celentano DD, Solomon SS. HIV care continuum among men who have sex with men and persons who inject drugs in India: barriers to successful engagement. Clin Infect Dis. 2015 Dec 1;61(11):1732-41. doi: 10.1093/cid/civ669. Epub 2015 Aug 6.


Responsible Party:	Gregory M. Lucas, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01686750 History of Changes
Other Study ID Numbers:	R01DA032059 R01MH089266
Study First Received:	September 13, 2012
Last Updated:	March 16, 2016
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 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 September 23, 2016