Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected Men Who Have Sex With Men (MSM) in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 8
- 主要终点
- HIV status at screening for each MSM recruited
研究概览
简要总结
The purpose of this study is to develop and assess the efficacy of an integrated strategy that includes feasible and scalable interventions to identify, recruit, link to care, retain in care, attain, and maintain viral suppression among HIV-infected men who have sex with men (MSM) in the United States (US).
详细描述
This study will use deep-chain respondent driven sampling (DC-RDS) and direct recruitment (DR) to identify and recruit HIV-infected MSM who are not virally suppressed. A subset of these men will be enrolled into one of two study arms. The intervention arm will provide a Case Manager (CM) intervention package designed to enhance linkage to care, antiretroviral treatment (ART) initiation, treatment adherence and retention in care. The control arm will provide the standard of care (SOC) for linkage to care, initiation of ART, treatment adherence and retention in care. The primary outcome of the study is viral suppression 12 months after enrollment. Phylogenetic methods will be used to evaluate the relationship between viruses in study participants. Mathematical modeling will be performed using demographic, behavioral, and clinical data generated from this study and other sources to estimate the population-level impact of the CM intervention on HIV incidence and to estimate the level of identification, linkage, ART coverage and viral suppression that would be required to achieve a substantial reduction in HIV incidence among MSM in the US settings where the study is conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Individuals who meet all of the following criteria are eligible for study screening:
- •Biological male (at birth)
- •Self-report of history of anal intercourse with another man
- •16 years or older
- •Individuals who are eligible for screening and who meet all of the following criteria are eligible for enrollment into the CM intervention and SOC control arms:
- •HIV-infected, as defined in the HPTN 078 Study-Specific Procedures (SSP) Manual
- •Not virally suppressed (defined as HIV VL ≥ 1000 copies/ml)
- •Can receive HIV care at one of the participating clinics (as chosen by each site)
- •No current plan to relocate in the 24 months following enrollment
排除标准
- •Individuals who meet any of the following criteria will be excluded from study screening:
- •Unable or unwilling to provide consent/assent for study participation.
- •Active or previous participation in an HIV vaccine trial.
- •Any condition that, in the opinion of the Investigator of Record (IoR), would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
- •Individuals who are eligible for screening, but who meet the following criteria are excluded from enrollment into the CM intervention and SOC control arms:
- •Current participation in a linkage or ART adherence study
结局指标
主要结局
HIV status at screening for each MSM recruited
时间窗: At Baseline
HIV status
HIV viral load at month 24 of participants randomized
时间窗: 24 months
time driven HIV viral load
HIV viral load at screening for each MSM recruited
时间窗: 12 months
HIV viral load
次要结局
- CD4 status at baseline(At Baseline)
- Baseline Demographics(At Baseline)
- Wave of recruitment for each man recruited by DC-RDS(During recruitment period)
- Number of all care visits from randomization through the end of 12 months follow up(Over 12 months)
- Date of recruitment for each man recruited by DC-RDS(During recruitment period)
- HIV viral load of those randomized(HIV viral load at Months 3, 6, 9, 12)
- HIV viral load status at baseline(At Baseline)
- Time of all care visits from randomization through the end of 12 months follow up(Over 12 months)
- HCV status at baseline(At Baseline)
- Syphilis status at baseline(At Baseline)
- Self-reported sexual risk behavior of unprotected anal intercourse, characteristics of 3 most recent partners) at baseline and 24 months(12 months)