Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

NCT01686750 | Completed Results DMC

• 3 other identifiers: NA_00047702R01DA032059R01MH089266
• Study Type: interventional
• Target: 21,726
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Keywords

HIV; injection drug use; men who have sex with men; voluntary counselling and testing; risk reduction; sexually transmitted infections; community viral load; antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• Proportion Reporting HIV Testing in the Prior 12 Months

  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.

  2 years

Secondary Outcomes (15)

• Proportion of HIV-infected Participants Aware of Status

  2 years

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

  2 years

• Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy

  2 years

• Community Viral Load

  2 years

• Proportion of HIV-infected Participants With Suppressed HIV RNA

  2 years

Study Arms (2)

Integrated care centers

EXPERIMENTAL

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

Standard services

NO INTERVENTION

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.

Interventions

Integrated care centers BEHAVIORAL

Integrated care centers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Key Informant Interviews:
• Persons may be included in the key informant interviews if they meet all of the following criteria:
• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

YR Gaitonde Center for AIDS Research and Education

Chennai, Tamil Nadu, 600113, India

Location

Related Publications (10)

• 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.

  PMID: 25849835 BACKGROUND

• 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.

  PMID: 25715105 BACKGROUND

• 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.

  PMID: 25486851 BACKGROUND

• 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.

  PMID: 23801014 BACKGROUND

• 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. doi: 10.1186/s12913-016-1905-5.

  PMID: 27842543 BACKGROUND

• 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.

  PMID: 26251048 BACKGROUND

• 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.

  PMID: 30952565 RESULT

• Prabhu S, Mehta SH, McFall AM, Srikrishnan AK, Vasudevan CK, Lucas GM, Celentano DD, Solomon SS. Substance use is associated with condomless anal intercourse among men who have sex with men in India: a partner-level analysis. BMC Public Health. 2022 Apr 11;22(1):722. doi: 10.1186/s12889-022-13192-y.

  PMID: 35410326 DERIVED

• 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. 2020 Jan;72(1):67-74. doi: 10.1016/j.jhep.2019.09.022. Epub 2019 Oct 8.

  PMID: 31604081 DERIVED

• 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.

  PMID: 27036994 DERIVED

MeSH Terms

Conditions

HIV Infections; Homosexuality; Risk Reduction Behavior; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Gregory M.Lucas
• Organization: Johns Hopkins University

glucas@jhmi.edu

410-614-0560

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 18, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 16, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-06

Locations

IN (1)