HIV Transmission in the Era of Scaling up Access to Antiretroviral Therapy in Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Clustering of HIV genomic sequences
研究概览
简要总结
The goal of this observational study is to understand patterns of HIV transmission in a high-prevalence area in Ethiopia, and to compare viral genetic information in people with HIV who are newly diagnosed and have not been exposed to antiretroviral therapy with persons receiving antiretroviral therapy without viral suppression.
The main questions it aims to answer are:
- Do people with HIV who fail to achieve viral suppression contribute to the ongoing spread of HIV in Ethiopia, or does HIV transmission mainly occur between persons with no exposure to such therapy?
- Are viruses with drug-resistance mutations transmitted onwards from people with HIV receiving antiretroviral therapy who fail to achieve viral suppression? * Which factors are involved in treatment failure and emergence of drug-resistant viruses longitudinally?
Participants will be enrolled with regard to history of antiretroviral therapy exposure (newly diagnosed/treatment-naïve vs. treatment-experienced with lack of viral suppression), using persons on antiretroviral therapy with viral suppression for control. We will compare the following outcomes between these groups:
- Clustering of viral genetic sequences at inclusion (implying linked transmission)
- Prevalence of drug-resistance-associated mutations at inclusion
- Viral suppression and emergence of drug-resistance mutations during follow-up
详细描述
Background Persons with incomplete viral suppression during antiretroviral therapy (ART) may harbor drug-resistant viruses, which have capacity for onwards transmission. The investigators hypothesize that individuals with previous or current exposure to ART contribute to HIV transmission, and that this includes transmission of drug-resistant viruses. This hypothesis is addressed by the use of molecular epidemiological analysis of viral sequences from persons newly diagnosed with HIV and those with ongoing viral replication during ART, combined with data on transmission risk behavior. In addition, based on findings described above, the investigators will include data on socio-demographic conditions in this analysis.
The chance of achieving viral suppression after treatment modification for persons with detectable viremia during ART is frequently compromised by the presence of drug-resistance mutations, adherence problems or irregular drug supply. There is limited data on the efficacy of dolutegravir (currently recommended as part of 1st and 2nd line ART regimens in sub-Saharan Africa) as a component of ART regimens in low-income settings. The investigators hypothesize that persons with incomplete viral suppression during prior ART are at increased risk of emergence of drug-resistance mutations during dolutegravir-based treatment, including mutations conferring dolutegravir resistance. The investigators will explore this hypothesis with deep sequencing of HIV RNA detected during longitudinal follow-up, with special regard to previous ART experience.
Methods Participants will be recruited and followed at public health facilities (hospitals and health centers) in the city of Adama and the surrounding area (population >600 000 inhabitants), located along the main transport highway in Ethiopia. The HIV prevalence in this area is considerably higher than the national average (9.3% among pregnant women).
Two categories of HIV-positive men and women aged >16 years are eligible for inclusion if specific criteria for the different categories (explained below) are met and written informed consent is provided.
i. Newly diagnosed persons; recruited in connection to HIV testing and/or first presentation to care, with no current or prior exposure to ART.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent Positive HIV test result
排除标准
- 未提供
研究组 & 干预措施
Individuals diagnosed with HIV infection
People with HIV
干预措施: Exposure to antiretroviral therapy (Other)
结局指标
主要结局
Clustering of HIV genomic sequences
时间窗: 2023-2024
Clustering indicating transmission between persons on antiretroviral therapy with lack of viral suppression and persons newly diagnosed with HIV
次要结局
- Clustering of HIV genomic sequences with drug-resistance mutations(2023-2024)
- Lack of viral suppression longitudinally during antiretroviral therapy(2024-2026)
- Emergence of drug-resistance mutations longitudinally during antiretroviral therapy(2024-2026)