Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

• ClinicalTrials.gov Identifier: NCT01686750
• Recruitment Status: Completed
• First Posted: September 18, 2012
• Results First Posted: July 16, 2019
• Last Update Posted: July 16, 2019
• Sponsor: Johns Hopkins University
• 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

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21726 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

Arms and Interventions

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

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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

  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Study Protocol and Statistical Analysis Plan  [PDF] November 14, 2016

More Information

Publications of Results:

Solomon SS, Solomon S, McFall AM, Srikrishnan AK, Anand S, Verma V, Vasudevan CK, Balakrishnan P, Ogburn EL, Moulton LH, Kumar MS, Sachdeva KS, Laeyendecker O, Celentano DD, Lucas GM, Mehta SH; Indian National Collaboration on AIDS Study. Integrated HIV testing, prevention, and treatment intervention for key populations in India: a cluster-randomised trial. Lancet HIV. 2019 May;6(5):e283-e296. doi: 10.1016/S2352-3018(19)30034-7. Epub 2019 Apr 2.

Other 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.

Solomon SS, Lucas GM, Celentano DD, McFall AM, Ogburn E, Moulton LH, Srikrishnan AK, Kumar MS, Anand S, Solomon S, Mehta SH. Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India. BMC Health Serv Res. 2016 Nov 14;16(1):652.

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.

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

Solomon SS, Quinn TC, Solomon S, McFall AM, Srikrishnan AK, Verma V, Kumar MS, Laeyendecker O, Celentano DD, Iqbal SH, Anand S, Vasudevan CK, Saravanan S, Thomas DL, Sachdeva KS, Lucas GM, Mehta SH. Integrating HCV testing with HIV programs improves hepatitis C outcomes in people who inject drugs: A cluster-randomized trial. J Hepatol. 2019 Oct 8. pii: S0168-8278(19)30588-4. doi: 10.1016/j.jhep.2019.09.022. [Epub ahead of print]

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.

• 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
• Results First Posted: July 16, 2019
• Last Update Posted: July 16, 2019
• Last Verified: June 2019

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:

Infection; HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents