A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Retention in care with viral suppression
研究概览
简要总结
This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.
详细描述
This study is a randomized trial that will compare outcomes with standard and same-day treatment among patients with TB symptoms at HIV diagnosis. The standard group will receive same-day chest x-ray as well as Xpert Ultra testing with a spot specimen (with 48-hour turn-around-time). Participants will return for Xpert Ultra results and early morning sputum testing on Day 2. TB treatment will be provided on the day of diagnosis (Day 0 for those with high clinical and radiographic suspicion of TB, and Day 2 for those diagnosed by spot Xpert Ultra). Standard group participants who are not diagnosed with TB will be tested and treated for other opportunistic infections (OIs), as clinically indicated, and will initiate ART on Day 7. The same-day group will receive Xpert Ultra testing (with same-day results) and chest x-ray with same-day ART or TB treatment (on Day 0) based on test results. They will also be tested and treated for other OIs as clinically indicated. They will provide early morning sputum for repeat testing on Day 1. Both groups will receive Xpert Ultra testing on both spot and early morning specimens, with liquid culture on both specimens as the diagnostic gold standard; those with TB will start ART according to WHO guidelines.
Three specific aims are proposed:
Aim 1: To compare the proportion of participants in each group who are alive and in care with undetectable viral load (<200 copies/ml) at 48 weeks after HIV testing. Hypothesis: The proportion of participants retained in care with undetectable viral load will be 51% in the standard and 65% in the same-day group.
Aim 2: To compare mortality in each group at 48 weeks after HIV testing. Hypothesis: Mortality will be 10% in the standard group and 4% in the same-day group.
Aim 3: To conduct a comparison of cost and cost-effectiveness of standard and same-day care, where cost is measured by the mean treatment cost and effectiveness is measured by being alive and in care with plasma HIV-1 RNA level <200 copies/ml at 48 weeks after HIV testing. Hypothesis: Same-day treatment will cost less per patient retained in care with undetectable viral load.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Men and women of ≥18 years of age
- •Presence of cough, fever, night sweats or weight loss
- •Ability and willingness to give written informed consent
- •Documentation of positive HIV status (test conducted at GHESKIO)
- •Acceptance of HIV diagnosis, defined as affirmative responses to two questions: "I believe that HIV and AIDS exist" and "I believe that the results of my HIV test show that I am infected".
排除标准
- •Any use of ART in the past
- •Treatment for TB in the year prior to screening visit
- •Pregnancy or breastfeeding at the screening visit
- •Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician
- •Score of <3 for any of the 7 questions on the ART readiness survey
- •Planning to transfer care to another clinic during the study period
- •Symptoms consistent with WHO stage 4 neurologic disease (cryptococcal meningitis, TB meningitis; central nervous system toxoplasmosis; HIV encephalopathy; progressive multifocal leukoencephalopathy)
- •Severe illness, classified as one of the WHO "danger signs" of temperature >39 degrees Celsius, pulse >120 beats/minutes, respiratory rate >30, or inability to walk unaided.
结局指标
主要结局
Retention in care with viral suppression
时间窗: 48 weeks after HIV testing
Proportion of participants who are in care with HIV-1 RNA \<200 copies/ml
次要结局
- Viral suppression(48 weeks after HIV testing)
- Time in clinic(First study day and first study month)
- Coping with HIV diagnosis(2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing)
- Incidence of immune reconstitution inflammatory syndrome (IRIS)(48-week study period)
- Measure of hope and optimism(2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing)
- Last missed dose of medication(2 Weeks, 12 Weeks, 24 Weeks, 48 Weeks)
- Mortality(48 weeks after HIV testing)
- Adherence by 3-day self-report(48 weeks after HIV testing)
- Connectedness to Treatment Setting(2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing)
- Treatment failure(48 weeks)
- Adverse events(48-week study period)
- Patient satisfaction(12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing)
- Time to death(48-week study period)
- Mean treatment cost per participant(48 weeks after HIV testing)
- Adherence by medication possession ratio(48 weeks after HIV testing)
- TB testing characteristics(These diagnostic tests will be conducted during the first week of study enrollment)
- TB diagnosis after ART initiation(48-week study period)
研究者
Serena Patricia Koenig
Associate Physician
Brigham and Women's Hospital