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

NCT03876483 | Unknown

• 2 other identifiers: STUDY00003392R34MH114834
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transition From Pediatric to Adult HIV Care

Keywords

HIV; Adolescents; ART

Outcome Measures

Primary Outcomes (3)

• Transition readiness

  Transition readiness assessment questionnaire

  12-months after enrollment

• Adherence

  3-item self-report measure

  12-months after enrollment

• Retention in adult care

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

  12-months after enrollment

Other Outcomes (5)

• Perceived social support

  12-months after enrollment

• ART knowledge

  12-months after enrollment

• HIV treatment self-efficacy

  12-months after enrollment

Study Arms (2)

Standard of Care

NO INTERVENTION

Youth enrolled in care at control facilities will receive current standard of care related to HIV care and transition to adult care.

Virtual peer support group

EXPERIMENTAL

Youth enrolled in care at intervention facilities will be invited to participate in a virtual peer support program

Behavioral: Virtual peer support group

Interventions

Virtual peer support group BEHAVIORAL

Intervention package will consist of a WhatsApp group setup and organized by the study. Participants will be divided into 1-3 WhatsApp groups, each with 10-55 youth. Each group will be facilitated by a study staff member trained as a counselor. The facilitator will send weekly messages to the group. Messages from the facilitator will not contain overtly HIV-related language. These messages are intended to spark unstructured discussion among study participants, or with the facilitator, at any time through the WhatsApp group or individually. Subsequent messages from the study will answer participant questions or correct misinformation. Standard operating procedures (SOPs) will be developed for standardizing responses to the questions received so that study staff follow national guidelines and local practice standards to respond.

Virtual peer support group

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator
• Kenyatta National Hospital: collaborator

Study Sites (1)

Kenyatta National Hospital

Nairobi, Kenya

Location

Study Officials

• Brandon L Guthrie, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Public Health, Global Health

Model Details: Facilities randomized to receive the behavioral intervention or standard of care

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: March 11, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)