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临床试验/NCT03516318
NCT03516318终止不适用

Using Social Media to Improve ART Retention and Treatment (SMART) Outcomes Among Youth Living With HIV (YLHIV) in Nigeria - The Youth SMART Study

FHI 3601 个研究点 分布在 1 个国家目标入组 355 人开始时间: 2018年9月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
FHI 360
入组人数
355
试验地点
1
主要终点
12-month retention in HIV services

研究概览

简要总结

A randomized control trial to test the effectiveness of a structured online support group, SMART (Social Media to improve ART Retention in Treatment) Connections, to improve retention in HIV care services among youth living with HIV (YLHIV) in Nigeria.

详细描述

Study aim is to examine the effect of an online structured support group intervention (SMART Connections) designed to improve retention in HIV care services among youth ages 15-21 years living with HIV enrolled in ART services. A randomized control trial in which youth living with HIV (YLHIV) will be allocated to standard of care (control) or standard of care plus an online support group and followed for 12 months. Structured questionnaires will be administered to participants at baseline, 6 and 12 months. Clinical data will also be extracted on participants. In-depth interviews with a subset of participants and intervention implementers will be completed at the end of the intervention period. Although participants will be recruited from health facilities, the intervention is conducted "virtually," by trained facilitators, not within the health facilities.

研究设计

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

入排标准

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

入选标准

  • HIV positive and know their status
  • Actively on ART for less than 12 months, including newly initiating patients
  • Age 15 to 24 years
  • Can demonstrate basic literacy necessary to participate in online chats

排除标准

  • Unable to attend the initial intervention group meeting for treatment participants
  • Currently enrolled in another research study related to HIV service retention or ART adherence
  • Critically or severely ill requiring hospitalization or such that the individual is unable to provide informed consent at the time of study recruitment

研究组 & 干预措施

SMART Connections

Experimental

The intervention components include:

  • Informational messages that reflect the content of the structured group counseling curriculum and are posted to the Facebook group wall on a regular basis for approximately 4 to 5 months
  • Moderated, closed group chats in a "secret" Facebook group where YLHIV can interact with their peers and with a trained support group facilitator
  • Access to a trained facilitator via Facebook Messenger for the duration of the intervention who will be able to provide information or basic counseling on ART/HIV care related issues, with referral to health care services as needed

干预措施: SMART Connections (Behavioral)

Control

No Intervention

All study participants, in both study arms, will receive standard services currently available to YLHIV in these facilities and communities. The services currently include: routine clinical care for HIV treatment including laboratory testing (CD4, viral load tests); active case management by community volunteers with intensive adherence support during the first 4 weeks of ART; adherence support through phone calls and SMS (short messaging service) reminders; and enhanced adherence counseling for patients with unsuppressed viral loads.

结局指标

主要结局

12-month retention in HIV services

时间窗: 12 months

This main outcome is defined as the proportion of study participants retained in clinical HIV services and on treatment at 12 months after enrollment. We will abstract data from the clinic electronic medical record system on date of all visits, which are typically monthly, to ART services between enrollment and the end-line of this study. Retention is defined as having attended a scheduled HIV clinic visit within three months of the visit date. For our primary analysis, using a survival analysis approach, we will record the dates for all scheduled clinic visits for each participant, then follow the data up to three months from the date of the last visit attended. If a participant fails to return after a scheduled visit for more than three months, the date of the missed visit will be the date of loss to follow-up recorded, unless a death or transfer of service is documented.

次要结局

  • Social support score(12 months)
  • Adherence to antiretroviral treatment(12 months)

研究者

发起方
FHI 360
申办方类型
Other
责任方
Sponsor

研究点 (1)

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