Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686750
• Other study ID #: NA_00047702
• Secondary ID: R01DA032059R01MH
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: June 2017

Study information

• Verified date: June 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21726
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Behavioral:
• Integrated care centers

Locations

Country	Name	City	State
India	YR Gaitonde Center for AIDS Research and Education	Chennai	Tamil Nadu

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins University	Elton John AIDS Foundation, National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), YR Gaitonde Centre for AIDS Research and Education

Country where clinical trial is conducted

India, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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 t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of HIV-infected Participants Aware of Status	Proportion of HIV-positive participants that were aware of their status at the time of the visit	2 years
Secondary	Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months		2 years
Secondary	Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy		2 years
Secondary	Community Viral Load	Average log(10) HIV RNA concentration among HIV-infected participants	2 years
Secondary	Proportion of HIV-infected Participants With Suppressed HIV RNA	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)	2 years
Secondary	Prevalence of Recent HIV Infection		2 years
Secondary	Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months		2 years
Secondary	Proportion of IDU Reporting Drug Abstinence in Prior 6 Months		2 years
Secondary	Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months		2 years
Secondary	Number of Non-main Male Partners in Prior 6 Months in MSM		2 years
Secondary	Proportion Reporting Substance Abuse Among MSM		2 years
Secondary	Proportion With Depressive Symptoms	Participants with Score >=10 on Patient Health Questionnaire-9	2 years
Secondary	Number of Unprotected Sexual Acts Reported by MSM		2 years
Secondary	Vicarious Stigma as Assessed by 6-item Stigma Scale	Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma	2 years
Secondary	Proportion Reporting Spouse Ever Tested for HIV		2 years