Same Day Community-based ART Initiation Versus Clinic-based Pre-ART Assessment and Counselling for Individuals Newly Tested HIV-positive During Community-based HIV Testing in Rural Lesotho - a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Viral suppression
研究概览
简要总结
The CASCADE-trial is a two-armed open-label randomized controlled trial conducted in rural Lesotho. Participants who were tested HIV-positive during community-based HIV testing and counseling campaigns are randomized to the intervention or control arm. Allocation is 1:1 with parallel assignment.
Participants in the control arm follow the standard of care after a community-based HIV test result: They are referred to the nearest clinic where they will receive baseline laboratory testing and adherence counseling. After at least 2 clinic visits for adherence counseling they can start anti-retroviral therapy (ART). After ART-initiation they have to attend monthly follow-up at the clinic for drug refill. Individuals randomized to the intervention arm are proposed same day community-based ART initiation combined with less frequent follow-up visits. The primary outcomes are linkage to care at 3 months and viral suppression at 12 months after having tested HIV-positive during the community-based HIV testing and counseling campaigns.
详细描述
A published version of the trial protocol can be downloaded at:
http://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-2972-6
Background
In November 2014 the Joint United Nations Programme on HIV/AIDS (UNAIDS) published the 90-90-90 targets for 2020 (UNAIDS 2014). The strategy aims at a massive scale-up in coverage of antiretroviral therapy (ART) among individuals infected with HIV. Based on accumulated evidence that viral suppression through successful ART reduces the risk of transmission(Cohen 2011), it is expected that - if achieved - the 90-90-90 targets would lead to a reduction of the yearly global HIV-incidence from 2 million currently to 500'000 by 2020 (Jones 2014). In 2015 two randomized controlled trials showed the benefit of starting ART as early as possible for infected individuals - even if CD4-cell counts were above the threshold of 500 cells/mL (TEMPRANO 2015; INSIGHT START 2015), leading the World Health Organization (WHO) to recommend that anyone infected with HIV should start ART as soon as possible after diagnosis (WHO 2015). A "seek-test-treat" strategy bears, however, unprecedented challenges in settings where HIV is hyperendemic and resources may be limited (Hull 2014; Delva 2015).
The Continuum of Care Cascade ("the cascade") involves the steps HIV-infected individuals have to take in order to achieve viral suppression. It starts with knowing one's HIV status, continues with linkage to care after a positive HIV test, initiation of ART, uninterrupted continuation of ART (retention in care and adherence to medication), and ends with viral suppression (MacCarthy 2015). Already prior to announcement of the "seek-test-and-treat" approach, weaknesses in the cascade often hampered the effectiveness of HIV programs in resource-rich as well as resource-poor settings (Yehia 2015; Kratzer 2012). In Sub-Saharan Africa the care cascade is still far from the 90-90-90 targets with only 29% of infected individuals estimated to be on ART and virally suppressed in 2013. In order to achieve the UNAIDS targets innovative, effective, and practical approaches for improving the care cascade are thus urgently needed (Mills 2013; Piot 2015).
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
- •HIV infection newly diagnosed during community-based HTC-campaigns
- •Never been on triple-ART
- •Lives and/or works in the district of Butha-Buthe and declares to seek follow-up at one of the 6 health facilities involved in the study
- •Signed written informed consent
排除标准
- •Pregnant or breast-feeding
- •Already enrolled in chronic care for another disease, such as tuberculosis or diabetes
- •Clinical WHO-stage 4 or active tuberculosis
- •Positive cryptococcal antigen test
研究组 & 干预措施
Standard of care
Standard of care in Lesotho. ART-initiation after at least two clinic visits for pre-ART counseling and monthly follow-up visits at the clinic thereafter.
干预措施: Standard of care (Other)
Same-day ART initiation with less frequent follow-up visits
Proposition of same-day ART initiation with less frequent follow-up visits thereafter.
干预措施: Same-day ART initiation (Other)
结局指标
主要结局
Viral suppression
时间窗: 12 months
Viral suppression 12 months after positive HIV test result. Viral suppression is defined as a viral load \<100 copies/mL between 11 and 14 months after diagnosis of HIV-infection.
Linkage to care
时间窗: 90 days
Linkage to care within 3 months after having been tested HIV positive during the HTC-campaign. A patient is considered to have linked to care if he/she attends the clinic at least once within 90 days after HIV diagnosis.
次要结局
- 1-year retention in care(12 months)
- Viral suppression under ART(6 months after ART initiation)
- Change in body weight(12 months)
- Change in CD4 cell count(12 months)
- Change in haemoglobin(12 months)
- New clinical WHO stage 3 or 4 events(12 months)
研究者
Niklaus Labhardt
MD, MIH
Swiss Tropical & Public Health Institute