Clinical trial NCT01686750: Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: YR Gaitonde Centre for AIDS Research and Education
name: Elton John AIDS Foundation
First posted: 2012-09-18
Enrollment: 21726
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Proportion Reporting HIV Testing in the Prior 12 Months
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of HIV-infected Participants Aware of Status
timeFrame: 2 years
measure: Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months
timeFrame: 2 years
measure: Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy
timeFrame: 2 years
measure: Community Viral Load
timeFrame: 2 years
measure: Proportion of HIV-infected Participants With Suppressed HIV RNA
timeFrame: 2 years
measure: Prevalence of Recent HIV Infection
timeFrame: 2 years
measure: Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months
timeFrame: 2 years
measure: Proportion of IDU Reporting Drug Abstinence in Prior 6 Months
timeFrame: 2 years
measure: Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months
timeFrame: 2 years
measure: Number of Non-main Male Partners in Prior 6 Months in MSM
timeFrame: 2 years
measure: Proportion Reporting Substance Abuse Among MSM
timeFrame: 2 years
measure: Proportion With Depressive Symptoms
timeFrame: 2 years
measure: Number of Unprotected Sexual Acts Reported by MSM
timeFrame: 2 years
measure: Vicarious Stigma as Assessed by 6-item Stigma Scale
timeFrame: 2 years
measure: Proportion Reporting Spouse Ever Tested for HIV
timeFrame: 2 years
Other outcomes:
Locations:
city: Chennai
country: India
facility: YR Gaitonde Center for AIDS Research and Education
state: Tamil Nadu
Study officials:
affiliation: Johns Hopkins University
name: Gregory M Lucas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Shruti Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: David D Celentano, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: YR Gaitonde Centre for AIDS Research and Education
name: Suniti Solomon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: YR Gaitonde Centre for AIDS Research and Education
name: Aylur Srikrishnan, BA
role: PRINCIPAL_INVESTIGATOR
affiliation: YR Gaitonde Centre for AIDS Research and Education
name: Suresh Kumar, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Sunil S Solomon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.