A Community-based Phase III, Cluster Randomized Trial of Point-of-care CD4 Testing and Enhanced Screening and Prophylaxis in Advanced HIV Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- 24-week survival with retention in care
研究概览
简要总结
A community-based Phase III, cluster randomized trial that seeks to determine the 24 week survival with retention in care of point of care CD4 testing with visitect and an enhanced package of screening and prophylaxis for opportunistic infections among patients with advanced HIV disease.
详细描述
The study will be carried out in a population of HIV-infected adults with advanced HIV disease (CD4 <200 cells/µL) in Uganda. It will be a Randomized controlled trial, Phase III in Uganda over a duration of 5 years assessing 24 weeks survival with retention in care. @4 clinic will be randomized to either receive the enhanced package or standard of care.
Description of Intervention Arm
- Point-of-care CD4 testing via Visitect (point of care semi Quantitaive CD4 LFA) lateral flow assay (LFA)
- Enhanced package of opportunistic infection screening and prophylaxis for CD4<200, including:
- FujiFilm SILVAMP TB LAM (FujiLAM)
- Isoniazid (INH) + rifapentine: 1 month of therapy for latent TB(Tuberculosis) infection
- Cryptococcal Antigen semi-quantitative (CrAg-SQ) LFA (Immy)
- Treatment for disseminated CNS cryptococcal infection if high blood CrAg titer (>3+ CrAg SQ)
Description of Standard of Care Arm
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 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
- •Age >18 years
- •CD4<200 cells/µL
- •Ability and willingness to give informed consent for the enhanced package of care arm.
排除标准
- •Known virologic suppression (viral load <1000 copies/mL) within prior 3 months
- •Cannot or unlikely to attend regular clinic visits
结局指标
主要结局
24-week survival with retention in care
时间窗: 24 weeks
Comparison will be made between study arms of those who receive POC CD4 testing vs. those who receive standard flow cytometry, and those who receive the enhanced package of OI screening and prophylaxis, vs. those who receive the current WHO standard.
次要结局
- Evaluate sensitivity and specificity of the different TB point of care tests.(24 weeks)
- Incidence of OIs and associated hospitalization and mortality(Six months)
- Tolerability and adherence to prophylaxis regimen and associated grade 3 to 5 adverse events(24 weeks)