PERSON-CENTERED APPROACHES TO VIREMIA: CONNECTION, RAPPORT, AND ENGAGEMENT STUDY
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Updated Estimates of Viremia and Care Status
研究概览
简要总结
The study aims to increase the reach of the person-centred interpersonal practices by developing and accessing a tailored, scalable, and sustainable approach that meets the distinctive needs of populations identified as most disproportionately affected by viremia in Zambia. The study population include pregnant and breastfeeding women, children, adolescents and adult that are more than thirty -30 days late for their next hospital appointments.The study will be implemented over a period of 36 months in 24 facilities in Lusaka and Central province, Zambia.
详细描述
The study has three aims, that include (1) To assess barriers to sustained viral suppression through identifying prevailing pathways to viremia (2) Apply Human Centred Design methods with stakeholders to co-create person-centred pathways to strengthen viral suppression, with particular attention to vulnerable groups (3) To test P-CoRE package with a focus on high- priority populations contributing to remaining viremia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that are lost to follow up ([LTFU] from HIV care i.e. confirmed >30 days late for a scheduled appointment) at the time of sampling. (i.e. not people who were previously LTFU but then returned and have a documented VL.)
- •Individuals returning to care after being out of care and not taking ART with no VL measure (i.e., unmeasured viremia)
- •Patients that are 6 months late for a scheduled Viral Load (VL) according to Ministry of Health guidelines at the time of sampling (regardless of care status)
- •Patients that have a last documented VL that is elevated, > 1000 copies/ml at time of sampling in current clinic population (CCP) (regardless of care status)
- •Participant that are willing to provide written informed consent in English, or any of the local languages that include Nyanja or Bemba.
排除标准
- •Patients that are unable to provide consent or unwilling to participate in the study
- •Participant who is NOT living with HIV/AIDS;
- •Participant is too sick i.e., failing to talk, general discomfort and emergency cases);
研究组 & 干预措施
Tracing to Ascertain Outcome
干预措施: Interventions will be developed in aim 2 of the study. (Other)
结局指标
主要结局
Updated Estimates of Viremia and Care Status
时间窗: 2 years
The study will use a sampling based approach for outcome ascertainment as used in the Better Information for Health in Zambia(BetterInfo) study https://www.cidrz.org/wp-content/toolkits/betterinfo/, but adapt procedures so they are focused on assessments of viremia (rather than mortality as in the initial BetterInfo study) (21). This approach leverages data collected during routine care and augments it with targeted data collection in a smaller sample of clients with incomplete data (i.e., missing VL measurements) to provide robust and epidemiologically rigorous estimates for the full clinic population.
次要结局
未报告次要终点