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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA032059 | U.S. NIH Grant/Contract | View source | |
| R01MH089266 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
| YR Gaitonde Centre for AIDS Research and Education | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
|
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated care centers | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months |
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Inclusion Criteria:
Key Informant Interviews:
Persons may be included in the key informant interviews if they meet all of the following criteria:
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
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
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
Exclusion Criteria:
Key Informant Interviews:
Persons will be excluded from the key informant interviews if they meet any of the following criteria:
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
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
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
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YR Gaitonde Center for AIDS Research and Education | Chennai | Tamil Nadu | 600113 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25849835 | Background | 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. | |
| 25715105 | 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. |
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Recruited by respondent-driven sampling in 22 sites in India.
| ID | Title | Description |
|---|---|---|
| FG000 | Integrated Care Centers | Integrated care centers will provide HIV prevention and treatment services to high risk populations of injecting drug users (IDU) or MSM in an accepting and supportive environment.
|
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | percentage of participants | 2 years | clusters | clusters |
|
This study was based on cross-sectional surveys. Therefore adverse events were only documented at the time of the survey visit (1 day).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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.
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory M.Lucas | Johns Hopkins University | 410-614-0560 | glucas@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2016 | Jun 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006716 | Homosexuality |
| D040242 | Risk Reduction Behavior |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Elton John AIDS Foundation |
| OTHER |
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| 2 years |
| Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy | 2 years |
| Community Viral Load | Average log(10) HIV RNA concentration among HIV-infected participants | 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) | 2 years |
| Prevalence of Recent HIV Infection | 2 years |
| Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months | 2 years |
| Proportion of IDU Reporting Drug Abstinence in Prior 6 Months | 2 years |
| Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months | 2 years |
| Number of Non-main Male Partners in Prior 6 Months in MSM | 2 years |
| Proportion Reporting Substance Abuse Among MSM | 2 years |
| Proportion With Depressive Symptoms | Participants with Score >=10 on Patient Health Questionnaire-9 | 2 years |
| Number of Unprotected Sexual Acts Reported by MSM | 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 | 2 years |
| Proportion Reporting Spouse Ever Tested for HIV | 2 years |
| 25486851 | 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. |
| 23801014 | 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. |
| 27842543 | 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. |
| 26251048 | 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. |
| 30952565 | Result | 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. |
| 41995596 | Derived | Hamill 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. |
| 35410326 | Derived | 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. |
| 31604081 | 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. |
| 27036994 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Clusters |
|
| years |
| Clusters |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| At least secondary school education | Participants who have had at least a secondary school education. | Count of Participants | Participants | Participants |
|
| 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. |
|
|
|
| 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 | Participants who tested HIV-positive at the survey visit | Posted | Mean | Full Range | percentage of participants | 2 years | clusters | clusters |
|
|
|
|
| Secondary | Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months | HIV-positive survey participants | Posted | Mean | Full Range | percentage of participants | 2 years | clusters | clusters |
|
|
|
|
| Secondary | Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy | HIV-positive participants that meet criteria for antiretroviral therapy in India at the time of the study | Posted | Mean | Full Range | percentage of participants | 2 years | clusters | clusters |
|
|
|
|
| Secondary | Community Viral Load | Average log(10) HIV RNA concentration among HIV-infected participants | Samples were not collected therefore there is no data to report. | Posted | 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) | HIV-positive participants who meet criteria for antiretroviral therapy | Posted | Mean | Full Range | percentage of participants | 2 years | clusters | clusters |
|
|
|
|
| Secondary | Prevalence of Recent HIV Infection | Samples were not collected therefore there is no data to report. | Posted | 2 years |
|
|
| Secondary | Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months | Participants from the PWID sites | Posted | Mean | Full Range | percentage of participants | 2 years | clusters | clusters |
|
|
|
|
| Secondary | Proportion of IDU Reporting Drug Abstinence in Prior 6 Months | Participants at PWID sites | Posted | Mean | Full Range | percentage of participants | 2 years | clusters | clusters |
|
|
|
|
| Secondary | Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months | Participants at MSM sites | Posted | Mean | Full Range | percentage of participants | 2 years | clusters | clusters |
|
|
|
|
| Secondary | Number of Non-main Male Partners in Prior 6 Months in MSM | Participants at MSM sites | Posted | Mean | Full Range | partners | 2 years | clusters | clusters |
|
|
|
|
| Secondary | Proportion Reporting Substance Abuse Among MSM | Samples were not collected therefore there is no data to report. | Posted | 2 years |
|
|
| Secondary | Proportion With Depressive Symptoms | Participants with Score >=10 on Patient Health Questionnaire-9 | Posted | Mean | Full Range | percentage of participants | 2 years | clusters | clusters |
|
|
|
|
| Secondary | Number of Unprotected Sexual Acts Reported by MSM | Samples were not collected therefore there is no data to report. | Posted | 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 | Posted | Mean | Full Range | score on a scale | 2 years | clusters | clusters |
|
|
|
|
| Secondary | Proportion Reporting Spouse Ever Tested for HIV | Participants with a spouse (opposite sex) | Posted | Mean | Full Range | percentage of participants | 2 years | clusters | clusters |
|
|
|
|
| 0 |
| 11,001 |
| 0 |
| 11,001 |
| 0 |
| 11,001 |
| EG001 | 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. | 0 | 10,725 | 0 | 10,725 | 0 | 10,725 |
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| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |