Ngoma Thandiwe, Kamanga Aniset, Scott Nancy, Morgan Allison, Reddy Marri Anushka, Makwalu Taurai, Mulenga Lloyd, Sivile Suilanji, Benade Mariet, Haimbe Prudence, Shakwelele Hilda, Rosen Sydney
Clinton Health Access Initiative, Lusaka, Zambia.
Boston University School of Public Health, Boston, MA, 02118, USA.
Gates Open Res. 2025 Aug 27;9:66. doi: 10.12688/gatesopenres.16359.1. eCollection 2025.
The proportion of HIV-positive individuals who present for initiation or re-initiation of antiretroviral therapy (ART) with advanced HIV disease (AHD) and are at risk for morbidity and mortality remains high throughout sub-Saharan Africa. In Zambia, where 20% of ART initiators are diagnosed with AHD, little is known about the characteristics of those starting ART with AHD, why treatment initiation is delayed, how AHD clinical management influences clinical and non-clinical outcomes, or implementation of national AHD guidelines at facility level.
AHD-Zambia is a mixed-methods observational study to describe AHD clients and care during the first six months after starting or re-starting ART in Zambia. The study will be conducted at 24 public sector primary health facilities in four provinces. It will enroll ART clients screened for AHD during a three-month data collection period (Cohort 1), clients screened for AHD in the 12 months prior to the data collection period (Cohort 2), patients hospitalized for AHD-related conditions (Cohort 3); and clinical providers at the study sites who manage clients with AHD (Cohort 4). Data collection will include quantitative surveys, medical record review during the 12 months before and after enrollment, qualitative interviews, and focus group discussions. Facility-level indicators will also be collected. Outcomes will include detailed profiles of AHD clients and their 6 and 12-month retention in care and viral suppression, provider and client views on barriers to and preferences for AHD care, and assessment of facility fidelity to AHD guidelines.
This study will generate a comprehensive profile of clients presenting with AHD in Zambia, including clinical, demographic, social, and behavioral characteristics, treatment outcomes, and barriers to providing guideline-compliant care. Findings will provide insight into the delivery of AHD services, identify gaps in implementation, and support improvements to retention and care during the early treatment period.
Clinicaltrials.gov NCT06904456.
在撒哈拉以南非洲地区，前来启动或重新启动抗逆转录病毒治疗（ART）且患有晚期HIV疾病（AHD）、存在发病和死亡风险的HIV阳性个体比例仍然很高。在赞比亚，20%的ART启动者被诊断患有AHD，但对于那些患有AHD开始接受ART治疗者的特征、治疗启动延迟的原因、AHD临床管理如何影响临床和非临床结局，以及国家AHD指南在机构层面的实施情况，人们了解甚少。
赞比亚AHD研究是一项混合方法的观察性研究，旨在描述赞比亚开始或重新开始ART治疗后头六个月内患有AHD的患者及其护理情况。该研究将在四个省份的24个公共部门初级卫生机构进行。它将纳入在为期三个月的数据收集期内接受AHD筛查的ART患者（队列1）、在数据收集期前12个月内接受AHD筛查的患者（队列2）、因AHD相关病症住院的患者（队列3）；以及研究地点管理患有AHD患者的临床提供者（队列4）。数据收集将包括定量调查、入组前后12个月的病历审查、定性访谈和焦点小组讨论。还将收集机构层面的指标。结局将包括AHD患者的详细概况及其6个月和12个月的护理留存率和病毒抑制情况、提供者和患者对AHD护理障碍和偏好的看法，以及对机构遵循AHD指南情况的评估。
本研究将生成赞比亚患有AHD患者的综合概况，包括临床、人口统计学、社会和行为特征、治疗结局以及提供符合指南护理的障碍。研究结果将深入了解AHD服务的提供情况，找出实施中的差距，并支持改善早期治疗期间的留存率和护理情况。
Clinicaltrials.gov NCT06904456
