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临床试验/NCT04567693
NCT04567693已完成不适用

Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV: a Pilot Study

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2020年10月22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
93
试验地点
1
主要终点
Viral Suppression

研究概览

简要总结

The objectives of this study are to pilot test the effect of reducing time to spaced-out appointments from 18 to 6 months for newly-diagnosed people living with HIV (PLWH) in Rwanda who have initiated antiretroviral therapy (ART). PLWH are currently required to visit the health center monthly for ART and clinical appointments for the first 18 months on ART, after which they can attend quarterly. Reducing the time to spaced-out appointments from 18 to 6 months has the potential to reduce the burden on patients and the health system, but may lead to suboptimal treatment outcomes. To better understand the effects of early spaced-out appointments as well as the degree of viral load monitoring needed to determine stability on ART, the investigators will conduct a 3-arm pilot intervention study. The investigators will randomize participants to 1) 6-month advancement to spaced-out appointments after 1 viral load measurement; 2) 6-month advancement to spaced-out appointments after 2 viral load measurements; or 3) usual care. The investigators will compare the study arms with respect to viral suppression at 12 months after enrollment in ART care (primary outcome) and appointment/ pharmacy adherence (secondary outcome).

详细描述

Most countries in sub-Saharan Africa have adopted differentiated care models for people living with HIV (PLWH), including Rwanda. Current Rwandan HIV guidelines classify newly-diagnosed PLWH as "unstable", requiring monthly visits to the health facility. Before they can advance to being "stable" patients, with spaced-out appointments that allow them to visit the health facility every three months, they must be on antiretroviral therapy (ART) for 18 months and virally suppressed on two consecutive measurements. Patients face multiple barriers to attending frequent appointments including structural issues (such as distance to the health facility, transportation cost, long waiting times) and facing stigma while traveling to and while at the health facility. Reducing the time newly-diagnosed PLWH spend in the "unstable" category could potentially decrease the burden on patients and the health facility and potentially decrease the costs of frequent appointments. The investigators therefore propose a pilot study to examine the effect of reducing the time from ART initiation to advancement to the "stable" category from 18 to 6 months. The investigators will enroll 90 patients: 30 will be randomized to 6-month advancement to spaced out appointments after 1 viral load is measured (at 5 months after enrollment in ART care) ("Early 1"); 30 will be randomized to 6-month advancement to spaced-out appointments after 2 viral loads are measured (at 3- and 5-months after enrollment in ART care) ("Early 2"); and 30 will be randomized to continue in usual care with monthly visits ("Usual care"). The investigators will compare study arms with respect to viral suppression at 12 months (primary outcome) and appointment/pharmacy adherence (secondary outcome). The investigators hypothesize that reducing the time to the "stable" category with spaced out appointments will be feasible, acceptable, not inferior to 18 months with respect to viral suppression or adherence, and will be cost-effective.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly-diagnosed with HIV (within 6 months);
  • enrolled in care at study health facility;
  • initiated ART.

排除标准

  • planning on moving away from health center/Kigali in the next 12 months;
  • unable to provide informed consent;
  • enrolled in care while pregnant;
  • co-infected with tuberculosis;
  • concurrent known mental health or substance use disorder.

结局指标

主要结局

Viral Suppression

时间窗: Measured at 12 months after enrollment into ART care

Percentage of participants with suppressed viral load (less than 200 copies/ml)

次要结局

  • Provider Acceptability of Reduced Time to Spaced-out Appointments(Measured at 12 months after enrollment into ART care)
  • Appointment Adherence(Measured at 12 months after enrollment into ART care)
  • Participant Acceptability of Reduced Time to Spaced-out Appointments(Measured at 12 months after enrollment into ART care)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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