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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21,726
- 试验地点
- 2
- 主要终点
- Proportion Reporting HIV Testing in the Prior 12 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Integrated care centers (Behavioral)
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.
结局指标
主要结局
Proportion Reporting HIV Testing in the Prior 12 Months
时间窗: 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.
次要结局
- Proportion of IDU Reporting Drug Abstinence in Prior 6 Months(2 years)
- Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months(2 years)
- Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months(2 years)
- Vicarious Stigma as Assessed by 6-item Stigma Scale(2 years)
- Proportion of HIV-infected Participants Aware of Status(2 years)
- Community Viral Load(2 years)
- Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months(2 years)
- Prevalence of Recent HIV Infection(2 years)
- Proportion Reporting Spouse Ever Tested for HIV(2 years)
- Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy(2 years)
- Proportion of HIV-infected Participants With Suppressed HIV RNA(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(2 years)
- Number of Unprotected Sexual Acts Reported by MSM(2 years)