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临床试验/NCT02833441
NCT02833441已完成不适用

The Peer Support Intervention - Supporting HIV Positive Adolescents in Zimbabwe to Improve HIV Care Continuum Outcomes

University of Zimbabwe2 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
214
试验地点
2
主要终点
Virologic suppression rate in the Peer Support Intervention i group compared with the standard of care group following 48 weeks in the Peer Support Intervention.

研究概览

简要总结

Youth with evidence of virologic failure defined as an HIV VL>400 copies/mL on two consecutive occasions at least 1 month apart will be eligible for enrollment. Youth will be randomized to a community based peer counseling support group or clinic based standard of care, with viral load, and drug monitoring evaluations at 3 month intervals to determine the efficacy of the intervention in improving adherence and virologic suppression.

详细描述

Title The Peer Support Intervention - supporting HIV positive adolescents in Zimbabwe to improve HIV care continuum outcomes

Short Title The Peer Support Intervention

Study Design Prospective randomized study

Study Duration 2 years

Study Population 250 Youth (ages 10-24 years) with virologic failure

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
Single (Investigator)

入排标准

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

入选标准

  • Documented HIV positive
  • Age > 10 years and ≤ 24 years
  • Two consecutive HIV VL>400 copies/mL, at least one month apart
  • Residence within 50 km of Harare
  • Able to provide written informed consent (age 18 or older) or assent (age <18 years)

排除标准

  • Inability to provide informed consent or assent
  • Past or current involvement in the Zvandiri Intervention Program

研究组 & 干预措施

Peer Support Intervention

Experimental

Adolescents/young adults in the Peer Support Intervention arm will be referred to a Peer Support Intervention support group within their own or nearby community. This support group will meet monthly and will be facilitated by a professional HIV counsellor together with a Peer Support Intervention counselor. The Peer Support Intervention counsellors will provide regular counselling to their allocated participants through home visits and SMS messages. Each participant will be visited once a week in their home. Whatsapp messages will be delivered daily to each participant by the Community Adolescent Treatment Supporters. The agreed messages will briefly enquire about the participant's well-being without specifically making reference to HIV or ARVs. In addition, participants' caregivers will be invited to a 3-session intervention to build knowledge, skills and confidence to better support their adolescents.

干预措施: Peer Support (Behavioral)

Standard of Care Practice

No Intervention

Participants in the standard of care group will receive adherence evaluations and counseling at the clinic as per the current standard of care. Current procedures involve a group counseling session given on Monday morning during which topics are discussed that are relevant to adolescents. In general children aged between 13-19 years attend these sessions. After the group counseling, adolescents also receive an individual counseling session before being evaluated by the clinic doctor. Youth are also encouraged to complete a self reported adherence questionnaire and may periodically undergo pill counts by the clinic counselors.

The adolescents may belong to peer support groups in their communities, however these activities are not part of the clinic program. No interventions are typically targeted at their caregivers.

结局指标

主要结局

Virologic suppression rate in the Peer Support Intervention i group compared with the standard of care group following 48 weeks in the Peer Support Intervention.

时间窗: 2 years

Virologic suppression

次要结局

  • Frequency of acquired drug resistance mutations among youth failing ART.(2 years)
  • Baseline prevalence of psychological distress among adolescents and young adults failing first line therapy(2 years)
  • Prevalence of psychological distress (measured using PHQ-A and SSQ) after 48 weeks of enrolment in the Peer Support Intervention compared with the standard of care(2 years)
  • Association between self-reported adherence, pill counts and objective surrogate markers of adherence obtained from plasma (viral load), DBS and hair (tenofovir concentrations).(2 years)
  • Effectiveness of point mutation assays for the detection of drug resistance as compared with standard sequencing techniques.(2 years)

研究者

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

Azure Tariro Makadzange

Lecturer

University of Zimbabwe

研究点 (2)

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