跳至主要内容
临床试验/NCT04568460
NCT04568460进行中(未招募)2 期

Standing Tall (Yima Nkqo): A Pilot Randomized Controlled Trial of a Community-Based Intervention to Improve Health Outcomes for Young Adults Newly Diagnosed With HIV in South Africa

Brigham and Women's Hospital4 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2020年11月25日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
100
试验地点
4
主要终点
ART Initiation

研究概览

简要总结

The investigators propose the Standing Tall study, a prospective randomised study of strategy to optimize community-based ART initiation in South Africa. Investigators will work closely with community members to integrate community-based ART. One hundred participants will be enrolled and followed for a total of up to 6 months. Those in the intervention arm will be provided with the ST intervention which includes a behavioral component and access to ART. The intervention will be linked to a clinic through a "Nurse Initiated Management of ART."

详细描述

The premise for our study is based on three decades of HIV research that supports the need for multi-component, multisystem interventions to promote testing, and adherence to treatment and care for young people living with HIV. The proposed intervention, Standing Tall, is informed and guided by Social Action Theory - a conceptual framework reflecting a holistic understanding of health behavior and motivational factors that foster and maintain behavior change. Standing Tall, a pilot randomized controlled trial, is designed to address multi-factorial barriers using (1) a socio-behavioral group intervention; (2) social support; (3) provision of immediate ART and refills. The primary outcome is ART initiation at three months, and the secondary outcome is viral load suppression at six months. Other tertiary/exploratory outcomes include behavioral outcomes and process evaluation of the intervention itself, and the use of point-of-care diagnostics.

The administrative supplemental funding provides support for an additional objective of this study: to understand how best to use point-of-care (POC) testing in clinical practice in order to improve HIV care and treatment for South African young people. Understanding patient perspectives and perceived barriers is critical to developing feasible, acceptable, and effective protocols for implementing POC testing. The primary aim for achieving this objective is to assess patient perspectives regarding POC testing through in-depth, semi-structured interviews among study participants enrolled in Standing Tall's second aim.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Complete an assessment of understanding
  • Provide informed consent
  • Are between ages 18-24
  • Present to Tutu Tester vans in Cape Town OR East London DTHF clinics (Duncan Village Day Hospital, Empilweni Gompo Health Centre, Gompo C Clinic) and test HIV+
  • Are ART-naïve
  • Are English or isiXhosa speakers
  • Reside in the Cape Town or East London metro area

排除标准

  • Are pregnant (must be referred to antenatal clinic if living with HIV)
  • Test positive for tuberculosis (must be referred to clinic for TB treatment prior to ART initiation)
  • Are unable to understand the process of informed consent

研究组 & 干预措施

Intervention Group Sessions

Experimental

Intervention group sessions will be delivered by lay health counselors. The sessions will reflect principles of co-learning, participatory design, and empowerment to promote engagement of young people in critical thinking and problem solving - including modeling, roleplaying, and interactive activities.

干预措施: Intervention Group Sessions (Other)

Standard of Care

No Intervention

This is the standard of care arm. Participants newly diagnosed with HIV will get a referral to the local primary health care setting of their choice for further management, including ART.

结局指标

主要结局

ART Initiation

时间窗: Six months

ART initiation will be assessed via a self-report measure of participants who will report whether they have or have not initiated ART.

次要结局

  • Wellness(Six Months)
  • Household Food Security(Six Months)
  • Viral Load Suppression(Six Months)
  • Mental Health(Six Months)
  • Substance Use(Six Months)
  • Perceptions of Acceptability(Six Months)
  • Stress(Six Months)
  • Resilience(Six Months)
  • Implementation Factors(Six Months)
  • Perceptions of Fidelity(Six Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ingrid Theresa Katz, M.D.

Associate Professor

Harvard Medical School (HMS and HSDM)

研究点 (4)

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