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临床试验/NCT02419066
NCT02419066已完成不适用

Examining HIV Treatment Adherence During Early Disease

Massachusetts General Hospital2 个研究点 分布在 2 个国家目标入组 904 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
904
试验地点
2
主要终点
HIV Adherence

研究概览

简要总结

Determine the level, patterns, and correlates of objectively measured ART adherence in early and advanced-stage disease, among pregnant and non-pregnant individuals, to determine the need and nature of interventions to support early ART adherence in Uganda and South Africa

详细描述

Specific Aims

Aim 1: Determine the level, patterns, and correlates of objectively measured ART adherence in early and advanced-stage disease, among pregnant and non-pregnant individuals, to determine the need and nature of interventions to support early ART adherence in Uganda and South Africa. Outcomes include: i) average adherence, ii) incidence of any 28-day period with <80% adherence, iii) number of ART interruptions >72 hours (which could lead to loss of viral suppression), and iv) detectable HIV RNA >400 copies/Ml at 6 and 12 months. Guided by prior work and the Theory of Vulnerable Populations, we hypothesize that incomplete adherence will be associated with a) early-stage, asymptomatic disease, b) pregnancy and postpartum periods, and c) multiple social and economic factors. Individuals with CD4 200-350 will not be studied in order to most efficiently identify differences at the extremes of early and advanced disease.

Aim 2: Given the known importance of social networks and social support for adherence in advanced-stage disease in some RLS, we will determine the extent to which social network cohesion, HIV serostatus disclosure within the network, and receipt of social support explain differential ART adherence in early and advanced-stage disease. We hypothesize that: i) compared to people with advanced-stage disease, people with early-stage disease will have less cohesive social networks, disclose their seropositivity to fewer network members, and receive less social support; ii) social network cohesion, serostatus disclosure, and social support will be associated with greater ART adherence; and iii) these associations will explain a significant portion of differential ART adherence in early versus advanced-stage disease. Additionally, although these factors have been well established previously in Uganda, prospective data is needed to account for secular trends related to treatment expansion and comparable data are needed from South Africa.

Aim 3: We will use qualitative methods to identify, describe and explain influences on ART adherence in early-stage disease to guide intervention development. In-depth understanding of influences on ART adherence among individuals with early-stage HIV disease will inform the focus of any needed ART adherence interventions for this population. We will conduct in-depth, adherence-focused qualitative interviews with (a) 50 HIV+ men and non-pregnant women, and (b) 50 HIV+ pregnant women, who initiate ART with early-stage disease. Interviews with pregnant women may be post-partum by the time of the interview. Equal numbers of individuals in these two groups will be drawn from the Uganda and South Africa sites.

Study Procedures

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • • Participants will be ART naïve and initiating within one month of enrollment date
  • Participants will be at least 18 years of age
  • Participants will be able to provide informed consent
  • Participants will live within 60 km of the clinic; intention to stay in the area for the next year
  • Participants will either be 1) in early-stage disease (CD4>350) with WHO stage I (i.e., asymptomatic), or 2) in advanced-stage disease (CD4<200).
  • Pregnant participants will be 34 weeks or less in pregnancy (per best available estimates

排除标准

  • • Live >60 km from the clinic (due to logistics of following participants) or intention to move outside 60km area within the next year
  • <18 years old (adherence patterns and determinants likely differ significantly from those >18 years)
  • Currently in an intermediate stages of disease (i.e., CD4 200-349; the intent of the proposed research is to examine differences in adherence between HIV-infected people initiating ART at early versus advanced-staged disease)
  • Women who have a CD4<200 and who report current pregnancy at the time of consent
  • Unable to provide informed consent (e.g., due to mental limitations or intoxication)
  • Anyone who does not initiate on ART within 1 month of the enrollment date
  • Any pregnant participant greater than 34 weeks in pregnancy (per best available estimate)

结局指标

主要结局

HIV Adherence

时间窗: 12 months

ART adherence will be monitored continuously, up to 12 months, using the Wisepill device.

次要结局

  • HIV RNA viral load(12 months)
  • Retention in HIV care(Attendance at scheduled visit (w/in 45 days))

研究者

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

Jessica Haberer, MD

Dr. Jessica Haberer, MD, MS

Massachusetts General Hospital

研究点 (2)

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