跳至主要内容
临床试验/NCT05723653
NCT05723653招募中不适用

Harnessing Social Network Support to Improve Retention in Care and Viral Suppression Among People Living With HIV in Chicago and Alabama: A Hybrid Type I Effectiveness-implementation Trial

University of Chicago13 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2023年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
13
主要终点
Missed Visit Proportion

研究概览

简要总结

The goal of this Hybrid Type I effectiveness-implementation trial is to test an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression among people living with HIV aged 18-49.

详细描述

This study is a Hybrid Type I effectiveness-implementation trial of an evidence-based, flexible, and tailored intervention that leverages existing social network members to promote retention in care and viral suppression. The study will be conducted in Chicago, Illinois and Alabama, two high burden priority areas in the National Ending the HIV Epidemic Plan. Both retention in care and viral suppression are critical targets in ongoing efforts to eliminate HIV, as persons adherent to antiretrovirals are unlikely to transmit HIV, and retention in care allows for ongoing monitoring of viral load and the delivery of other important services, e.g., case management, mental health, and substance use treatment.

Most clinic-based strategies to improve Continuum of Care outcomes focus on newly created network members, e.g., support groups, peer navigators, or case managers. In contrast, we identify and activate organic Support Confidants (SC)-those people who can offer the types of social support that can help to navigate life's complexities, including the stressors of living with HIV. The intervention uses sociograms, highly engaging social network diagrams, to identify an ideally positioned Support Confidant. Once a Support Confidant is identified, the Index and their Support Confidant attend a single session, in-person intervention with a trained interventionist. The intervention uses the Information Motivation Behavioral Skills Model, Motivational Interviewing, and Cognitive Behavioral Theory to promote Continuum of Care-specific support in the Index-Support Confidant relationship.

This study will conduct a Hybrid Type I randomized controlled trial with N=600 participants living with HIV, who will be randomized to receive the intervention (n=300) or treatment as usual (n=300). In addition, 300 Support Confidants also will be enrolled. At 12-months post-intervention, we will re-randomize dyads to continue receiving mini-boosters (n=150) or return to treatment as usual (n=150). Data collection at baseline, 12, and 18 months will include surveys and electronic medical record (EMR) data. The study will be implemented in community-based clinics and academic-affiliated health centers in Chicago and in Birmingham and Huntsville, Alabama. To study implementation in each setting and geographic context, we will use the Consolidated Framework for Implementation Research as the determinant framework and Reach, Effectiveness, Adoption, Implementation, and Maintenance as the evaluation framework. The specific aims of the study are to:

Aim 1: Evaluate the (a) effectiveness of a social support intervention versus treatment as usual over 12 months with 600 people living with HIV ages 18-49 and (b) value of continuing to offer social support over another 6 months. The primary outcomes are retention in care and Viral Suppression, as measured by electronic medical record data on missed visit proportion and viral load.

Aim 2: Examine if intervention effects (a) vary between Chicago and Alabama, (b) are mediated by changes in the Index's level of motivational readiness, self-efficacy, and stigma expectancies, and (c) are moderated by mental health and substance use at the Index level.

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

盲法说明

Due to the nature of the intervention, it is not possible to blind participants, interventionists, and investigators. However, we take the following steps to minimize bias, assess contamination, and enhance rigor: (1) collecting baseline data prior to randomization; (2) Treatment as Usual (TAU) providers are blinded to allocation; and (3) assessing contamination at follow-up surveys by identifying overlap between the networks of those in each study arm.

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • for Index Participants:
  • Aged 18-49 years old, inclusive
  • Speak English
  • Own a cell phone not shared with anyone else
  • Have missed at least one HIV care scheduled visit or have not been virally suppressed in the past 24 months.
  • Resides in Chicagoland, Illinois or Alabama

排除标准

  • for Index Men:
  • If a participant fails to meet all inclusion criteria
  • Inclusion Criteria for Support Confidants:
  • Index agrees to engage the Support Confidant
  • Age 18 years or older
  • Speaks English
  • Owns a cell phone not shared with others
  • Is not a romantic/sexual partner of the Index participant
  • Exclusion Criteria:
  • Romantic/Sexual partners of Index participant
  • Relationship strain or abuse present in Index-Support Confidant relationship

研究组 & 干预措施

Social Network Support Intervention Condition

Experimental

The intervention condition will be delivered by trained Intervention Case Managers to n=300 Index participants and their Support Confidant.

The intervention consists of (1) selection and invitation of a Support Confidant, (2) a face-to-face intervention between the Intervention Case Manager and the Index and Support Confidant, and (3) quarterly interactive mini-booster sessions delivered to the Index and Support Confidant via text or telephone, based on participant preference.

At 12 months, Index participants in the experimental condition will be re-randomized to either continue receiving quarterly interactive mini-booster sessions or to stop receiving mini-boosters and return to treatment as usual.

干预措施: Social Network Support Intervention (Behavioral)

Treatment as Usual Condition

No Intervention

Treatment as Usual is comprehensive and follows Department of Health and Human Services guidelines and local protocols on the provision of HIV primary care, which include scheduling one HIV primary care visit and lab tests (including viral load) once every six months, i.e., two HIV primary care visits per year. In addition, all sites provide standard case management and mental health and psychosocial support services to all patients.

结局指标

主要结局

Missed Visit Proportion

时间窗: 18 months

We count visits as scheduled (non-acute) visits to an antiretroviral prescribing provider. Missed Visit Proportion (MVP) is calculated as the proportion of total scheduled visits that are missed during the follow-up period. To permit longitudinal analyses, we shall also split the two-year follow-up period into eight three-month quarters and record, for each participant, whether he completed or missed his scheduled appointment during that quarter. Appointment and visit history to calculate MVP will be collected from each clinic's electronic medical record data.

Viral Suppression

时间窗: 18 months

Viral load (suppressed or not) will be measured in RNA copies/mL, with ≤200 copies/mL defined as viral suppression.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (13)

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