Viral Non-Suppression, Drug Resistance, Perceptions and Effectiveness of Intensive Adherence Counselling Among People Living With HIV/AIDS on Antiretroviral Therapy With Low-Level Viraemia in Uganda.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 136
- 试验地点
- 8
- 主要终点
- Proportions of people living with HIV (PLHIV) with a non-detectable viral load (below 50 copies/ml) in both the intervention and control arms of the study
研究概览
简要总结
Uganda uses a threshold of 1,000 copies/ml to determine HIV viral non-suppression among people living with HIV/AIDS (PLHIV) on treatment, which is indicative of either poor adherence or HIV virologic treatment failure; as per the recent WHO recommendations. The use of this high threshold of 1,000 copies/ml has resulted into an increase in the number of PLHIV having low-level viraemia (≥50 to <1,000 copies/ml) from 11.0% in 2017 to 35.0% in 2020 in Uganda. Different studies in developed countries have shown that low-level viraemia is associated with HIV drug resistance, and despite this, there is no intervention to manage and control low-level viraemia (LLV), as per the recent Uganda national HIV guidelines. With this increasing and unmanaged low-level viraemia (LLV), Uganda might never achieve the global targets of ending AIDS as epidemic by 2030, as stipulated by target 3.3 of SDG 3.
This study will therefore determine the effectiveness of intensive adherence counselling on achieving a non-detectable viral load (below 50 copies/ml) in the management of LLV among PLHIV on ART in Uganda. This study will generate useful information that might guide the review of the national HIV guidelines, to control and manage LLV among PLHIV on ART; and thereby enable Uganda to achieve the global goals of SDG 3, Target 3.3 and the national targets of Vision 2040.
详细描述
Study design This study will be a cluster randomized clinical trial, which will determine the effectiveness of IAC in achieving a non-detectable viral load among PLHIV on ART with LLV from selected health facilities from all the four regions of Uganda. The outcome of the study will be the proportions of PLHIV with a non-detectable viral load in both the intervention and control arms of the study.
Study setting The study will be conducted in selected health facilities from each of the four regions in Uganda (Central, Eastern, Northern and Western).
Study population The study will comprise of PLHIV on ART who have had recent VL result with LLV.
Sample size A sample size of 79 participants per arm will be estimated from; n = [(Zα/2 + Zβ)2 × {(p1 (1-p1) + (p2 (1-p2))}]/(p1 - p2)2 (Sakpal, 2010; Sullivan, 2020); with a power of 90% and a 5% level of significance to detect a 15% difference in PLHIV on ART who get a non-detectable viral load between those offered IAC and those who are not. IAC is an intervention used to manage PLHIV with a non-suppressed VL and 70% of these PLHIV attain viral suppression (WHO, 2016); and therefore, we assume that p2 is 0.7. PLHIV with LLV have suppressed VL and we assume IAC to even be more effective at about 90% in creating a non-detectable VL in these PLHIV, hence we assume p1 to be 0.9.
An equal sample size of 12 participants for each of the 8 clusters will be estimated from (Hemming et al., 2011) where nI is the number of participants required for each arm, k is the number of clusters, and p is the intra-cluster correlation estimate, which is 0.0180 (Barnhart et al., 2016), thus a total of 96 participants is required. Considering a design effect of 1.126 and an attrition rate of 20%, the resultant total sample size of 136 participants per study arm will be used, hence a total 17 participants will be recruited per cluster.
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
- Single (Participant)
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
- •People living with HIV (PLHIV) on antiretroviral therapy (ART) with recent viral load (VL) results having low-level viraemia (≥50 to <1,000 copies/ml)
- •PLHIV aged 18 years or above
排除标准
- •Critically sick PLHIV
- •Non-suppressed PLHIV
结局指标
主要结局
Proportions of people living with HIV (PLHIV) with a non-detectable viral load (below 50 copies/ml) in both the intervention and control arms of the study
时间窗: 3 completed months of IAC
Number of people living with HIV (PLHIV) with a non-detectable viral load (below 50 copies/ml) in both the intervention and control arms of the study
次要结局
未报告次要终点