跳至主要内容
临床试验/NCT03876483
NCT03876483Unknown不适用

Planning the mPACT Trial - mHealth Strategies for the Pediatric to Adult HIV Care Transition

University of Washington1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年3月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Transition readiness

研究概览

简要总结

In contrast all other age groups, adolescents (age 10-19 years) have experienced constant, rather than declining, HIV-related mortality in the last decade. This is due in part to poor retention in care and adherence to antiretroviral therapy (ART) in this age group. As youth living with HIV enter adulthood, they transition from pediatric to adult HIV care. The transition to adult care presents heightened challenges to retention, due to disruption of established relationships with pediatric healthcare providers and a shift to an adult care model that requires greater autonomy and offers less specialized support. Resources to support youth through the transition are lacking. Mobile technology for health promotion (mHealth) using social media is a promising approach to maintain engagement in care through the transition. mHealth reminders, education, and support from healthcare workers have been successful in improving ART adherence in the adult HIV care setting and there have been limited, though promising, results in youth care. This study will support the development of a novel mHealth strategy for the Pediatric to Adult HIV Care Transition (mPACT). The conceptual framework for this intervention is based on providing support to youth who are transitioning to adult care through a combination of virtual group peer support and 1-to-1 communication with a healthcare worker trained in youth HIV care.

The aims of this study are to (1) identify the specific barriers to successful youth transition to adult HIV care, develop the mPACT intervention messaging strategy, and create a prototype of the mHealth platform; (2) Pilot the mPACT intervention to determine its effect on the intermediate outcomes of transition preparedness, ART knowledge, stigma, depression, social and caregiver support.

Using an iterative mixed methods approach we will develop and pilot the mPACT intervention to improve transition to adult HIV care. Aim 1 focuses on identifying barriers, assessing user requirements, developing and refining communication content and strategies, and adapting existing technology platforms through in-depth individual interviews and focus group discussions and with youth living with HIV, healthcare works, caregivers, and policy makers. Aim 2 will pilot the intervention tool using a cluster randomized trial to evaluate the impact of the intervention on intermediate factors relevant to transition to adult HIV care.

详细描述

AIM 1a: Youth IDIs and caregiver and HCW/peer counselor FGDs Participants in in-depth individual interviews (IDIs) and focus group discussions (FGDs) will be recruited from the study clinics. IDIs and FGDs will be performed in a private room at the clinic from which the participant was recruited. IDIs and FGDs will be conducted by a trained qualitative interviewer fluent in English and Kiswahili. Before the IDI or FGD begins, socio-demographic information will be collected in standardized questionnaires using a tablet-based system (Open Data Kit, ODK). For youth, sociodemographic data to be collected include age, HIV treatment history, HIV status disclosure, family socio-economic status, education level, and technology access. For caregivers, data to be collected include age, relationship to the youth patient, and involvement in youth's HIV care. For HCW/peer counselors, data include age, professional role, time in practice and technology access. The interviewer will then describe procedures and norms for the IDI/FGD and participants will be given a chance to ask questions. Participants will be reminded that their participation is voluntary and they may refuse to answer any question or end the interview/FGD at any time. Participants will receive unique identification numbers and will not be addressed by their names to maintain confidentiality. The interviewer will then ask questions and facilitate a discussion based on a discussion guide. Aim 1a IDIs will last approximately 1 hour and Aim 1a FGDs will last 1.5 - 2 hours. The IDI/FGD will be audio recorded and the facilitator will take written notes. Discussions will be conducted in English or Kiswahili, depending on participant preferences. Notes will be compared to audio-recordings to fill in missing information, transcribed and translated to English (if necessary). Transcribed data will be de-identified. Audio-recorded interviews will be destroyed after the transcripts have been validated. Participants will be provided refreshments and KSh 400 to compensate for their time and transportation expenses to participate in the study. We will provide this monetary compensation to each participant at the conclusion of each IDI/FGD.

AIM 1a: Policy-maker IDIs Policy-makers will be approached and recruited to participate. IDIs will be performed in a private room at the policy-maker's place of work or at the study clinic, depending on the participant's preference. IDIs will be conducted by a trained qualitative interviewer fluent in English and Kiswahili. Before the IDI begins, socio-demographic information will be collected in standardized questionnaires using a tablet-based system (Open Data Kit, ODK). Data to be collected include age, professional role, and involvement with policy-making and implementation related to youth HIV care. The interviewer will then describe procedures and norms for the IDI and participants will be given a chance to ask questions. Participants will be reminded that their participation is voluntary and they may refuse to answer any question or end the interview/FGD at any time. Participants will receive unique identification numbers and will not be addressed by their name to maintain confidentiality. The interviewer will then ask questions and facilitate a discussion based on a discussion guide. Policy-maker IDIs will last approximately 1 hour. The IDI will be audio recorded and the facilitator will take written notes. Discussions will be conducted in English or Kiswahili, depending on participant preferences. Notes will be compared to audio-recordings to fill in missing information, transcribed and translated to English (if necessary). Transcribed data will be de-identified. Audio-recorded interviews will be destroyed after the transcripts have been validated.

AIM 1b: User-centered design FGDs with youth and HCW/peer counselors Based on input from interviews and FGDs conducted in Aim 1a, we will develop a prototype mHealth intervention that will use WhatsApp to provide peer support groups and 1-to-1 text messaging between youth and HCWs. The prototype will include messaging content, facilitation guides, and an interface to manage communication that will be used by facilitators and HSWs. To evaluate the acceptability of the prototype and to get feedback on how it can be improved, we will conduct 2 rounds of user-centered designed FGDs with youth and HCW.

We will evaluate the prototype intervention using user-centered design FGDs with youth living with HIV who are in the process of transitioning to adult care or have completed the transition and with HCWs/peer counselors who care for youth living with HIV. Participants for each set of FGDs will be recruited as described above. Following informed consent, participants will complete an enrollment visit in which questionnaire data will be collected using tablet-based ODK forms. For youth, data to be collected include sociodemographic characteristics such as age, family socioeconomic status, education level, technology access, HIV treatment history, social support, depression, stigma, ART knowledge and motivation, ART adherence. For HCWs/peer counselors, data include age, professional role, time in practice and technology access. FGDs will be conducted in 2 rounds. In the first round, FGDs with youth will explore their comprehension, interest and reactions to prototypical messages and discussion topics. FGDs with HCW will explore their reactions and comfort with prototypical messages and discussion topics. HCW will also be presented with the prototype message management interface, training materials, and their input sought on improvements. The second round of FGDs will recruit a new group of participants to evaluate the modified content and interface. Participants will be provided refreshments and KSh 400 (approximately $4) to compensate for their time and transportation expenses to each study visit, provided to participants at the conclusion of each visit.

Aim 2 Pilot intervention trial

研究设计

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

入排标准

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

入选标准

  • Aware of HIV status
  • Involved in youth HIV care
  • Ready but not yet transitioned to adult HIV care
  • Has access to mPACT intervention messaging platform

排除标准

  • Unable to provide informed consent

结局指标

主要结局

Transition readiness

时间窗: 12-months after enrollment

Transition readiness assessment questionnaire

Retention in adult care

时间窗: 12-months after enrollment

≥2 adult care visits in the last 6 months (medical records)

Adherence

时间窗: 12-months after enrollment

3-item self-report measure

次要结局

未报告次要终点

研究者

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

Brandon Guthrie

Assistant Professor, School of Public Health, Global Health

University of Washington

研究点 (1)

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