HIV Infection
Conditions
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
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.
Interventions
BEHAVIORALIntegrated care centers
Sponsors
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
YR Gaitonde Centre for AIDS Research and Education
Elton John AIDS Foundation
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion Reporting HIV Testing in the Prior 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months | 2 years | — |
| Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy | 2 years | — |
| Community Viral Load | 2 years | Average log(10) HIV RNA concentration among HIV-infected participants |
| Proportion of HIV-infected Participants With Suppressed HIV RNA | 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 | 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 HIV-infected Participants Aware of Status | 2 years | Proportion of HIV-positive participants that were aware of their status at the time of the visit |
| 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 | 2 years | Participants with Score \>=10 on Patient Health Questionnaire-9 |
| Number of Unprotected Sexual Acts Reported by MSM | 2 years | — |
| Vicarious Stigma as Assessed by 6-item Stigma Scale | 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 | 2 years | — |
| Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months | 2 years | — |
Countries
India
Participant flow
Recruitment details
Recruited by respondent-driven sampling in 22 sites in India.
Participants by arm
| Arm | Count |
|---|---|
| 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.
* 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 | 11,001 |
| 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.
* 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 | 11 |
| 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. | 10,725 |
| 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. | 11 |
| Total | 21,748 |
Baseline characteristics
| Characteristic | Integrated Care Centers | Standard Services | Total |
|---|---|---|---|
| Age, Continuous | 30 years | 29 years | 29 years |
| At least secondary school education | 8729 Participants | 7455 Participants | 16184 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11001 Participants | 10725 Participants | 21726 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 221 Participants | 272 Participants | 493 Participants |
| Sex: Female, Male Male | 10780 Participants | 10453 Participants | 21233 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11,001 | 0 / 10,725 |
| other Total, other adverse events | 0 / 11,001 | 0 / 10,725 |
| serious Total, serious adverse events | 0 / 11,001 | 0 / 10,725 |
Outcome results
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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Proportion Reporting HIV Testing in the Prior 12 Months | 36.9 percentage of participants |
| Standard Services | Proportion Reporting HIV Testing in the Prior 12 Months | 26.2 percentage of participants |
Comparison: We compared the sampling-weighted prevalence of outcomes at Integrated Care Centers (ICCs) and usual care from the evaluation survey. We used linear regression models that had terms for intervention status (integrated care vs usual care), stratum (PWID and MSM), and the baseline proportion of the outcome being assessed. Site-level proportions from both evaluation and baseline respondent-driven sampling were log transformed before being entered into the regression model.p-value: 0.0995% CI: [0.95, 1.81]Prevalence ratio
Secondary
Community Viral Load
Average log(10) HIV RNA concentration among HIV-infected participants
Time frame: 2 years
Population: Samples were not collected therefore there is no data to report.
Secondary
Number of Non-main Male Partners in Prior 6 Months in MSM
Time frame: 2 years
Population: Participants at MSM sites
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Number of Non-main Male Partners in Prior 6 Months in MSM | 3.0 partners |
| Standard Services | Number of Non-main Male Partners in Prior 6 Months in MSM | 3.1 partners |
95% CI: [-4.2, 4.2]
Secondary
Number of Unprotected Sexual Acts Reported by MSM
Time frame: 2 years
Population: Samples were not collected therefore there is no data to report.
Secondary
Prevalence of Recent HIV Infection
Time frame: 2 years
Population: Samples were not collected therefore there is no data to report.
Secondary
Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy
Time frame: 2 years
Population: HIV-positive participants that meet criteria for antiretroviral therapy in India at the time of the study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy | 57 percentage of participants |
| Standard Services | Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy | 46.8 percentage of participants |
95% CI: [0.77, 2.41]
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
Time frame: 2 years
Population: Participants who tested HIV-positive at the survey visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Proportion of HIV-infected Participants Aware of Status | 65.2 percentage of participants |
| Standard Services | Proportion of HIV-infected Participants Aware of Status | 59.4 percentage of participants |
95% CI: [0.8, 1.5]
Secondary
Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months
Time frame: 2 years
Population: HIV-positive survey participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months | 45.7 percentage of participants |
| Standard Services | Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months | 40.8 percentage of participants |
95% CI: [0.61, 1.81]
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)
Time frame: 2 years
Population: HIV-positive participants who meet criteria for antiretroviral therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Proportion of HIV-infected Participants With Suppressed HIV RNA | 47.3 percentage of participants |
| Standard Services | Proportion of HIV-infected Participants With Suppressed HIV RNA | 46.7 percentage of participants |
95% CI: [0.65, 1.28]
Secondary
Proportion of IDU Reporting Drug Abstinence in Prior 6 Months
Time frame: 2 years
Population: Participants at PWID sites
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Proportion of IDU Reporting Drug Abstinence in Prior 6 Months | 28.2 percentage of participants |
| Standard Services | Proportion of IDU Reporting Drug Abstinence in Prior 6 Months | 16.5 percentage of participants |
95% CI: [0.49, 7.16]
Secondary
Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months
Time frame: 2 years
Population: Participants from the PWID sites
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months | 30.1 percentage of participants |
| Standard Services | Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months | 31.8 percentage of participants |
95% CI: [0.42, 4.93]
Secondary
Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months
Time frame: 2 years
Population: Participants at MSM sites
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months | 56.2 percentage of participants |
| Standard Services | Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months | 69.3 percentage of participants |
95% CI: [0.53, 1.56]
Secondary
Proportion Reporting Spouse Ever Tested for HIV
Time frame: 2 years
Population: Participants with a spouse (opposite sex)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Proportion Reporting Spouse Ever Tested for HIV | 45.9 percentage of participants |
| Standard Services | Proportion Reporting Spouse Ever Tested for HIV | 46.8 percentage of participants |
95% CI: [0.64, 1.36]
Secondary
Proportion Reporting Substance Abuse Among MSM
Time frame: 2 years
Population: Samples were not collected therefore there is no data to report.
Secondary
Proportion With Depressive Symptoms
Participants with Score \>=10 on Patient Health Questionnaire-9
Time frame: 2 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Proportion With Depressive Symptoms | 13.4 percentage of participants |
| Standard Services | Proportion With Depressive Symptoms | 18.2 percentage of participants |
95% CI: [0.47, 1.52]
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
Time frame: 2 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Integrated Care Centers | Vicarious Stigma as Assessed by 6-item Stigma Scale | 2.9 score on a scale |
| Standard Services | Vicarious Stigma as Assessed by 6-item Stigma Scale | 4.6 score on a scale |
95% CI: [-3, -0.6]