Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations
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ClinicalTrials.gov Identifier: NCT01686750 |
Recruitment Status :
Completed
First Posted : September 18, 2012
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
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Condition or disease | Intervention/treatment | Phase |
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HIV Infection | Behavioral: Integrated care centers | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21726 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
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 |
Actual Study Start Date : | October 2012 |
Actual Primary Completion Date : | June 2017 |
Actual Study Completion Date : | June 2017 |
Arm | Intervention/treatment |
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Experimental: 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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Behavioral: Integrated care centers |
No Intervention: 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.
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- 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.
- Proportion of HIV-infected Participants Aware of Status [ Time Frame: 2 years ]Proportion of HIV-positive participants that were aware of their status at the time of the visit
- 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 ]Average log(10) HIV RNA concentration among HIV-infected participants
- Proportion of HIV-infected Participants With Suppressed HIV RNA [ Time Frame: 2 years ]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)
- 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 ]Participants with Score >=10 on Patient Health Questionnaire-9
- 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 ]Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma
- Proportion Reporting Spouse Ever Tested for HIV [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
- 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
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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
Exclusion Criteria:
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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686750
India | |
YR Gaitonde Center for AIDS Research and Education | |
Chennai, Tamil Nadu, India, 600113 |
Principal Investigator: | 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 |
Documents provided by Johns Hopkins University:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01686750 |
Other Study ID Numbers: |
NA_00047702 R01DA032059 ( U.S. NIH Grant/Contract ) R01MH089266 ( U.S. NIH Grant/Contract ) |
First Posted: | September 18, 2012 Key Record Dates |
Results First Posted: | July 16, 2019 |
Last Update Posted: | July 16, 2019 |
Last Verified: | June 2019 |
HIV injection drug use men who have sex with men voluntary counselling and testing |
risk reduction sexually transmitted infections community viral load antiretroviral therapy |
HIV Infections Infections Blood-Borne Infections Communicable Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |