跳至主要内容
临床试验/NCT04442399
NCT04442399已完成不适用

Pilot of Family-based Self-management for HIV-infected Adolescents in Two Clinics in Ndola

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年4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
50
试验地点
1
主要终点
Number of adolescent/caregiver pairs who attend Family Connections (feasibility)

研究概览

简要总结

The study design has two phases. The first phase is the refinement of intervention manual for an adolescent living with HIV (ALHIV)and their caregiver intervention, followed by a second phase feasibility pilot study. The study goals are to refine and pilot a feasible intervention that fosters resiliency and draws upon the strengths of adolescents and their families. Specific aims include to: (1) Refine activities and an intervention manual for a family-focused group intervention for adolescents and their caregivers to improve HIV self-management among adolescents living with HIV; (2) conduct a pilot study to assess the acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including Anti-Retroviral Therapy (ART) adherence, safer sex behaviors and stigma, comparing the intervention and comparison study arms.

详细描述

The need for effective interventions to support adolescent HIV self-management is particularly pressing in Sub-Saharan Africa (SSA) where the majority of the 2.1 million ALHIV reside. Highlighting the vulnerability of ALHIV is their increasing HIV-related mortality, up 50% in 2012 compared to 2005, while the global number of HIV-related deaths among all ages decreased by 30%. In response to the disparate burden of HIV mortality among ALHIV, combined with the compelling evidence from HIV prevention and chronic illness literature and research on the influential role of families, the study team propose to refine and pilot test an ALHIV/caregiver group intervention. This intervention will draw upon principles of Positive Youth Development (PYD) and Social Cognitive theory (SCT) to emphasize skills building, self-efficacy, youth participation, and strengthening adult relationships. The intervention will build upon an existing ALHIV support group guide and utilize trained facilitators to hold group sessions with ALHIV and their caregivers to: 1) improve understanding of HIV among ALHIV and caregivers; 2) help ALHIV develop strategies for healthy living including adherence to ART; 3) build the capacity of ALHIV to make informed decisions about their sexual and reproductive health; 4) build the capacity of caregivers to support ALHIV; and 5) help ALHIV develop life skills to communicate their HIV diagnosis effectively, and to plan for their future. The study design has two phases. The first phase is the refinement of the ALHIV/caregiver intervention manual followed by a second phase feasibility pilot study. The Study goals are to refine and pilot a feasible intervention that fosters resiliency and draws upon the strengths of adolescents and their families. Specific aims include to: (1) Refine activities and an intervention manual for a family-focused group intervention for adolescents and their caregivers to improve HIV self-management among adolescents living with HIV; (2) conduct a pilot study to assess the acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including ART adherence, safer sex behaviors and stigma, comparing the intervention and comparison study arms.

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

入选标准

  • Adolescents: 15 and 19 years old, aware of their HIV status, and had been on ART for at least six months
  • Caregivers:nominated by the adolescents and were at least 20 years old

排除标准

  • Caregiver: Being a biological parent is not an eligibility criterion

结局指标

主要结局

Number of adolescent/caregiver pairs who attend Family Connections (feasibility)

时间窗: Attendance over the course of the 6 month intervention collected using attendance log.

Feasibility was assessed based on attendance at the intervention sessions.We considered the intervention feasible if at least two-thirds of the pairs attended 80% or more of the intervention sessions.

Proportion of participants who would recommend the Family Connections program (acceptability)

时间窗: At the six-month endline data collection

The proportion of participants who reported during the endline survey that they would recommend the intervention to others.

次要结局

  • Proportion of participants with viral failure (1,000 copies or more per mL)(~ 6 months (from baseline to endline))
  • Youth Participants' adolescent internalized stigma measures (yes/no)(~ 6 months (from baseline to endline])
  • Youth Participants' mean ART adherence over six months using daily medication electronic monitoring system (MEMS) caps data(Collected monthly over the course of the six month intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验