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临床试验/NCT03099707
NCT03099707已完成不适用

The Treatment Ambassador Program: Pilot Testing a Peer-driven Intervention to Increase Treatment Initiation Among HIV-positive South Africans

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2017年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Number of Participants With Treatment Initiation at 3 Months After Study Enrollment

研究概览

简要总结

This study will evaluate the feasibility and acceptability of the Treatment Ambassador program - a peer-supported intervention targeting individuals living with HIV who have not started on treatment within at least 3 months of testing.

详细描述

Global HIV treatment initiatives have focused on increasing access to antiretroviral therapy (ART), with the goal of creating an "AIDS-free generation." There is growing evidence, however, that treatment availability alone is insufficient to stop the spread of the disease. Countries where HIV is hyperendemic, such as South Africa, will not achieve population-level reductions in HIV until incident infections have been dramatically reduced over a lifetime, and people living with HIV (PLWH) no longer wait to start treatment until they have symptoms of advanced AIDS. As South Africa expands ART eligibility to all people living with HIV, it remains unclear if promoting earlier ART initiation will lead to widespread uptake. These operational realities raise two fundamental questions: how will we close the gap from the 3.4 million PLWH currently on ART to treating the over seven million people who need care; and what does this portend for the future of Treatment as Prevention in South Africa? The investigators' prior research suggests that optimizing ART initiation for PLWH in South Africa will require an intervention to reduce individual barriers to starting ART, promote social support, and enhance linkages to the healthcare system. In the proposed study, the investigators will build upon our prior research to pilot test a socio-behavioral multi-component peer intervention, to ensure that South Africans living with HIV initiate and sustain treatment. Investigators will test this intervention through a pilot randomized-controlled trial. This multi-component intervention is designed to address barriers to ART initiation identified in prior qualitative research, framed through the Theory of Triadic Influence (TTI). TTI focuses upon three "streams of influence" that impact health behavior at the individual-, social-, and structural-levels. The intervention will be delivered by "Treatment Ambassadors," who are PLWH who will function in multiple capacities, and have received intensive training in motivational interviewing (MI), peer-support, and peer navigation. They will then provide the intervention in eight sessions over 8-14 weeks. The intervention will be individually tailored to address the three streams of influence on patient decision-making as follows: MI will address individual perceived risk and ambivalence in decision-making; peer-support will target interpersonal social factors; and patient navigation will promote ART initiation and counter structural barriers.

Investigators will enroll 90 participants (45 in each arm) with the goal of assessing feasibility and acceptability. Investigators enrolled 84 participants in total. The 90 participant mark was not met due to time constraints and our eligibility requirements. In addition, preliminary efficacy will be assessed through the following measures:

Primary Outcome Measure: Timely ART initiation (initiation within 3 months of enrollment) (assessed through the National Health Laboratory Service, pharmacy records, and medical chart abstraction).

Secondary Outcomes Measures: 1) HIV-1 RNA Suppression within the first 6 months of study enrollment (assessed through the National Health Laboratory Service).

  1. Behavioral Factors associated with failure to initiate ART in a timely manner.

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
None

入排标准

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

入选标准

  • Adults living with HIV who are 18 years and older, who have not initiated ART within 3 months of learning their status
  • Live within 60 km the testing center (due to prohibitive costs of following participants to remote locations);
  • English or Xhosa speaking; and
  • Eligible for treatment under current South Africa guidelines

排除标准

  • Unable to provide informed consent (e.g., due to intoxication or mental incapacity,
  • Persons less than 18 years of age,
  • Women who report current pregnancy at the time of consent. We are choosing to not include pregnant women in this study, because the study's recruitment site refers pregnant clients to more specialized care facilities that may better suit their needs.

结局指标

主要结局

Number of Participants With Treatment Initiation at 3 Months After Study Enrollment

时间窗: 3 months

Treatment Initiation will be measured at 3 months through clinic records, pharmacy data, and the National Health Laboratory Service (NHLS), a national database in South Africa. Primary data analysis will be an intent-to-treat analysis, which includes all randomized participants. Of note, every attempt will be made to continue assessing participants even if they drop out of treatment. In addition, investigators will replicate all analyses with the completers only. The hypothesis that the intervention will yield higher rates of antiretroviral therapy (ART) initiation by the completion of the intervention will be tested using Fisher's exact test; the treatment effect estimate will be summarized in terms of a relative risk and 95% confidence interval. Any baseline demographic or clinical variables identified as necessary covariates in preliminary analyses will be included in a logistic regression analysis that examines the main effect of treatment condition on the rates of ART initiation.

次要结局

  • CD4(6 months)
  • Number of Participants With Intervention Feasibility(Feasibility will be assessed during the intervention, an expected average timeframe of 8-14 weeks)
  • HIV-1 RNA Suppression at 6 Months Post-enrollment(6 months)
  • Number of Participants With Intervention Acceptability(Acceptability will be assessed during the intervention, an expected average timeframe of 8-14 weeks)

研究者

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

Ingrid Theresa Katz, M.D.

Assistant Professor and Research Scientist

Brigham and Women's Hospital

研究点 (1)

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