Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

NCT ID: NCT01686750

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21726 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Integrated care centers

Intervention Type: BEHAVIORAL

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Integrated care centers

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

YR Gaitonde Centre for AIDS Research and Education

OTHER

Sponsor Role: collaborator

Elton John AIDS Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory M Lucas, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Shruti Mehta, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

David D Celentano, ScD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Suniti Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

YR Gaitonde Centre for AIDS Research and Education

Aylur Srikrishnan, BA

Role: PRINCIPAL_INVESTIGATOR

YR Gaitonde Centre for AIDS Research and Education

Suresh Kumar, MPH

Role: PRINCIPAL_INVESTIGATOR

YR Gaitonde Centre for AIDS Research and Education

Sunil S Solomon, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

YR Gaitonde Center for AIDS Research and Education

Chennai, Tamil Nadu, India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 25849835 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25715105 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25486851 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23801014 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27842543 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26251048 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30952565 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35410326 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31604081 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27036994 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DA032059

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH089266

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00047702

Identifier Type: -

Identifier Source: org_study_id