Adolescent Coordinated Transition Nigerian HIV+ Youth (ACT)
2017年10月14日 更新者：Echezona Ezeanolue、University of Nevada, Las Vegas
Adolescent Coordinated Transition (ACT) to Improve Health Outcomes Among Nigerian HIV+ Youth
The purpose of this study is to evaluate the comparative effectiveness of a comprehensive, coordinated transition protocol which includes an early introduction to the adult provider, an integrated case management team and a peer-facilitated organized support group on retention in care, viral suppression and psychosocial wellbeing among adolescents living with HIV.
研究概览
详细说明
Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of ACT, a coordinated protocol for transitioning adolescents living with HIV (ALHIV) from pediatric to adult care (Intervention Group; IG) versus the usual abrupt transfer to adult care (Control group; CG) on rates of retention in care and viral suppression, and differences in perceived psychosocial wellbeing.
Twelve health facilities, two in each of the six geopolitical zones of Nigeria will be pair-matched and randomly assigned to either IG (N=6 health facilities) or CG (N=6 health facilities).
A total of 216 ALHIV will be enrolled in the study over a 36-month period.
The primary outcome will be the difference in the rate of retention between the groups.
Secondary outcomes will be difference in the rate of viral suppression and the difference in perceived psychosocial wellbeing.
Additionally, the investigators will conduct mediation/moderation analysis to examine the role of intermediate variables such as transition readiness, perceived mental health, social support, health locus of control, self-esteem and sexual risk behavior self-efficacy on the primary outcomes.
Implementation factors will be assessed using the hybrid 2 model.
研究类型
介入性
注册 (预期的)
216
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Abuja、尼日利亚
- 招聘中
- Center for Integrated Health Program
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接触：
- Bolanle Oyeledu, MD
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Abuja、尼日利亚
- 招聘中
- Centre for Clinical Care and Research
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接触：
- Ayodotun Olutola, MD
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Abuja、尼日利亚
- 招聘中
- Family Health International
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接触：
- Hadiza Khamofu, MD
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Lagos、尼日利亚
- 招聘中
- AIDS Prevention Initiative Nigeria
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接触：
- Prosper Okonkwo
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FCT
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Abuja、FCT、尼日利亚
- 招聘中
- Institute of Human Virology
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接触：
- Nadia Sam-Agudu
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
13年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Documented HIV infection
- Aware of HIV diagnosis
- Currently on ART
Exclusion Criteria:
- Medically unstable
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control
The control arm does not receive the ACT intervention.
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实验性的：ACT Intervention
Intervention activities include the three components of the ACT intervention: (1) alternating pediatric and adult clinic visits in the 12 month pre-transfer period (2) peer facilitated organized support group during the 24-month graduated transition period and (3) patient advocate and case management team to coordinate transfer process.
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Coordinated, graduated transition which includes an early introduction to the adult clinician during the PAPA pre-transfer period, a peer-facilitated organized support group aimed at improving transition readiness and addressing critical psychosocial skills including self-efficacy and locus of control and a case management team including a patient advocate who coordinates the transfer between pediatric and adult care teams.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Retention in care in care 6 months post-transfer
大体时间：6 months
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Proportion of participants who had at least 1 clinical visit to an HIV provider within the 6 months post-transfer
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6 months
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Retention in care 12 months post-transfer
大体时间：12 months
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Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within the 1 year period post-transfer
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12 months
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Retention in care 24 months post-transfer
大体时间：24 months
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Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within a 1 year period during the second year post-transfer
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24 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Viral Suppression
大体时间：Enrollment, baseline (12 months), 24 and 36 months
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Proportion of participants with undetectable viral load
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Enrollment, baseline (12 months), 24 and 36 months
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Mental Health and Wellbeing
大体时间：Enrollment, baseline (12 months), 24 and 36 months
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Mental health continuum-short form Questionnaire
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Enrollment, baseline (12 months), 24 and 36 months
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Health Locus of Control
大体时间：Enrollment, baseline (12 months), 24 and 36 months
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Health Locus of control / Self-esteem Questionnaire
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Enrollment, baseline (12 months), 24 and 36 months
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Social Support
大体时间：Enrollment, baseline (12 months), 24 and 36 months
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Functional Social Support Questionnaire
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Enrollment, baseline (12 months), 24 and 36 months
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Sexual Risk Behavior
大体时间：Enrollment, baseline (12 months), 24 and 36 months
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Sexual Risk Beliefs and Behavior Self Efficacy Questionnaire
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Enrollment, baseline (12 months), 24 and 36 months
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Transition Readiness
大体时间：Enrollment, baseline (12 months), 24 and 36 months
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Transition Readiness Assessment Questionnaire
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Enrollment, baseline (12 months), 24 and 36 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月28日
初级完成 (预期的)
2020年5月30日
研究完成 (预期的)
2021年6月30日
研究注册日期
首次提交
2017年5月9日
首先提交符合 QC 标准的
2017年5月11日
首次发布 (实际的)
2017年5月12日
研究记录更新
最后更新发布 (实际的)
2017年10月17日
上次提交的符合 QC 标准的更新
2017年10月14日
最后验证
2017年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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