HIV InfectionNCT01686750
Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations
A study testing Integrated care centers in people with HIV Infection, run by Johns Hopkins University at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Integrated care centers
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,726 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2012to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Key Informant Interviews:
- Persons may be included in the key informant interviews if they meet all of the following criteria:
- 18 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
Show all 26Show fewer
- Provide informed consent
- Focus groups:
- Persons may be included in the focus groups if they meet all of the following criteria:
- 18 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
- 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:
- 18 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 24 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
- Present a valid RDS referral coupon (unless a seed)
- Provide informed consent
Who cannot join
- 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
Show all 26Show fewer
- 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
- 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:
- 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 24 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
- Do not present a valid RDS referral coupon and are not a seed
- Do not provide informed consent
Trial locations and contacts
1 site in 1 country.
India1 site
YR Gaitonde Center for AIDS Research and Education
Chennai, Tamil Nadu, 600113
About this study
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
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
- Being tested
- Integrated care centers
- 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
- Medical subject headings
- HIV Infections, Homosexuality, Risk Reduction Behavior, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated care centersBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (15)
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
Measured: 2 years
Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months
Measured: 2 years
Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy
Measured: 2 years
Community Viral Load
Average log(10) HIV RNA concentration among HIV-infected participants
Measured: 2 years
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)
Measured: 2 years
Prevalence of Recent HIV Infection
Measured: 2 years
Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months
Measured: 2 years
Proportion of IDU Reporting Drug Abstinence in Prior 6 Months
Measured: 2 years
Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months
Measured: 2 years
Number of Non-main Male Partners in Prior 6 Months in MSM
Measured: 2 years
Proportion Reporting Substance Abuse Among MSM
Measured: 2 years
Proportion With Depressive Symptoms
Participants with Score >=10 on Patient Health Questionnaire-9
Measured: 2 years
Number of Unprotected Sexual Acts Reported by MSM
Measured: 2 years
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
Measured: 2 years
Proportion Reporting Spouse Ever Tested for HIV
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21,726 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Gregory M Lucas, MD, Principal investigator, Johns Hopkins UniversityShruti Mehta, PhD, Principal investigator, Johns Hopkins UniversityDavid D Celentano, ScD, Principal investigator, Johns Hopkins UniversitySuniti Solomon, MD, Principal investigator, YR Gaitonde Centre for AIDS Research and EducationAylur Srikrishnan, BA, Principal investigator, YR Gaitonde Centre for AIDS Research and EducationSuresh Kumar, MPH, Principal investigator, YR Gaitonde Centre for AIDS Research and EducationSunil S Solomon, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686750
- Sponsor's protocol ID
- NA_00047702
- Other IDs
- R01DA032059, R01MH089266
- Status last verified
- Jun 2019
- First submitted
- 13 Sep 2012
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 25849835Lucas 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.
PubMed 25715105Solomon 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.
PubMed 25486851Solomon 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.
PubMed 23801014Solomon 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.
PubMed 27842543Mehta 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.
PubMed 26251048Solomon 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.
PubMed 30952565Hamill MM, Gunaratne MP, McFall AM, Iqbal HS, Vasudevan CK, Anand S, Solomon SS, Mehta SH, Krishnan AK, Celentano DD, Lucas GM. Increasing Syphilis Prevalence Among MSM Across India Despite Improvements in the HIV Care Continuum. J Acquir Immune Defic Syndr. 2026 Jun 1;101(6):633-642. doi: 10.1097/QAI.0000000000003860.
PubMed 41995596Prabhu 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.
PubMed 35410326Solomon 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.
PubMed 31604081Solomon 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.
PubMed 27036994
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01686750
- Acronym / sponsor ID
- NA_00047702
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,726 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- 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
- Study start
- Oct 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated care centers | Experimental | Behavioral: Integrated care centersIntegrated 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Persons may be included in the key informant interviews if they meet all of the following criteria:
- 18 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated care centers | Behavioural | Integrated care centers |
Primary outcome
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.
15 secondary outcomes
Proportion of HIV-infected Participants Aware of Status
Time frame: 2 years
Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months
Time frame: 2 years
Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy
Time frame: 2 years
Community Viral Load
Time frame: 2 years
Proportion of HIV-infected Participants With Suppressed HIV RNA
Time frame: 2 years
Prevalence of Recent HIV Infection
Time frame: 2 years
Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months
Time frame: 2 years
Proportion of IDU Reporting Drug Abstinence in Prior 6 Months
Time frame: 2 years
Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months
Time frame: 2 years
Number of Non-main Male Partners in Prior 6 Months in MSM
Time frame: 2 years
Proportion Reporting Substance Abuse Among MSM
Time frame: 2 years
Proportion With Depressive Symptoms
Time frame: 2 years
Number of Unprotected Sexual Acts Reported by MSM
Time frame: 2 years
Vicarious Stigma as Assessed by 6-item Stigma Scale
Time frame: 2 years
Proportion Reporting Spouse Ever Tested for HIV
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25849835Solomon 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.
- Background: PubMed 25715105Lucas 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.
- Background: PubMed 25486851Solomon 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.
- Background: PubMed 23801014Solomon 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.
- Background: PubMed 27842543Solomon 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.
- Background: PubMed 26251048Mehta 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.
- Results publication: PubMed 30952565Solomon 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.
- Derived from this study: PubMed 41995596Hamill MM, Gunaratne MP, McFall AM, Iqbal HS, Vasudevan CK, Anand S, Solomon SS, Mehta SH, Krishnan AK, Celentano DD, Lucas GM. Increasing Syphilis Prevalence Among MSM Across India Despite Improvements in the HIV Care Continuum. J Acquir Immune Defic Syndr. 2026 Jun 1;101(6):633-642. doi: 10.1097/QAI.0000000000003860.
- Derived from this study: PubMed 35410326Prabhu 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.
- Derived from this study: PubMed 31604081Solomon 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.
- Derived from this study: PubMed 27036994Solomon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory M Lucas, MD principal investigator
Johns Hopkins University
Shruti Mehta, PhD principal investigator
Johns Hopkins University
David D Celentano, ScD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated care centers in people with HIV Infection, run by Johns Hopkins University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion Reporting HIV Testing in the Prior 12 Months (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01686750, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.