A Social Media Intervention to Improve Retention in Care for Adolescents and Young Adults With HIV in Uganda (REMAIN)

Retention Through mHealth for Adolescents and Young Adults With HIV in Care

Adolescents and young adults with HIV (AYWH) aged 15- 24 years are the fastest-growing population of people living with HIV worldwide. AYWH have worse outcomes along the HIV continuum of care than adults with HIV; HIV/AIDS is the second leading cause of mortality and the fourth leading cause of disability among AYWH worldwide. This study will develop a youth-friendly, mobile health (mHealth) intervention to improve retention in care that has the potential to improve AIDS-related mortality and morbidity among AYWH and decrease onward new transmission, thus contributing towards ending the HIV/AIDS pandemic.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Behavior
• Intervention / Treatment: Behavioral: A social media based intervention

Detailed Description

Background: Of the adolescents and young adults with HIV (AYWH) who initiate in care, only about 50% remain in care at 12 months; in 2020, AYWH recorded a 50% increase in AIDS-related mortality. These poor clinical outcomes among AYWH are multi-factorial and largely influenced by their neurodevelopmental stage and differ by route of infection. Current interventions to retain AYWH in care are ineffective and do not address the neurodevelopmental issues of AYWH. Social media-based mHealth interventions may offer flexible and attractive features to AYWH to help overcome these barriers. Candidate: The goal of the proposed K43 Emerging Global Leader Award is to support The investigator's research training to attain independence as a clinician-scientist focused on improving treatment and care for AYWH in low resourced settings. The investigator is currently a research fellow at Mbarara University of Science and Technology, Uganda. The proposed study will enable training in three areas: 1) Qualitative research skills, including design, data collection, analysis and interpretation; 2) Behavioural science skills to better understand influences of adolescent behaviour and implications for mHealth-based intervention development and deployment; 3) Skills in statistical methods for clinical trials to conduct clinical trials and longitudinal data analysis. This application builds on The investigator's current clinical experience and background in epidemiology, as well as ongoing formative work in mHealth intervention development and a highly supportive, multidisciplinary team of mentors. Research: The research goals of this proposal are to develop and test a psychosocial social media-based mHealth intervention to improve retention in care of AYWH attain viral suppression, therefore decreasing AIDS-related mortality and preventing onward HIV transmission. The investigator will identify the HIV knowledge gaps, experiences, and challenges among AYWH who are new or re-engaging in HIV care, characterizing these factors by route of infection (i.e., perinatal vs non-perinatal) among AYWH in resource limited populations.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julian Adong, MMed; Phone Number: +256 755553595; Email: jadong@must.ac.ug

Study Locations

• Uganda
  • Mbarara, Uganda
    • Recruiting
    • Mbarara University of Science and Technology
    • Contact: Julian Adong, MMed; Phone Number: +256 755553595; Email: jadong@must.ac.ug

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

The eligibility criteria is as follows:

For adolescents and young adults with HIV (AYWH)

1. AYWH who are aged 15-24
2. AYWH who are new to care (less than or equal to one month in care), or who are re-engaging in care after being lost to follow up for greater or equal to six months.
3. Fluent in English or Runyankole (the local language)
4. For aim 3, AYWH who have access (own or shared) to a smartphone

Exclusion criteria for AYWH 1) Inability to provide consent

For counsellors Inclusion criteria

1. Clinic counsellors who are ≥18 years
2. Clinic counsellors who have worked at the HIV clinic for ≥ 1 year

Exclusion criteria

1) Inability to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; These are the participants who will be randomised to receive the intervention at the start of the study.	Behavioral: A social media based intervention; WatsApp-based modules to influence retention in care behaviour
No Intervention: Wait list control arm; These are participants who will not receive the intervention initially, but will move to the intervention arm after 6 months of follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary intervention outcome will be the acceptability, feasibility of the intervention.	Acceptability will be measured using the Acceptability of Intervention Measure (AIM) and will be considered acceptable if ≥70% (35/50) of intervention participants rate all 4 items on the AIM (a 5-point Likert scale) as "agree" or higher. The intervention will be considered feasible if ≥70% (35/50) of intervention participants rate all 4 items on the Feasibility of Intervention Measure (FIM), (a 5-point Likert scale) as "agree" or higher.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	The secondary outcome of the intervention will be retention in care, which will be assessed at the end of 12 months. This will be defined as the proportion of participants active in care (i.e have not missed a scheduled appointment in the last 12 months) The investigators will compare the proportion of participants actively engaged in care in the immediate intervention and the deferred intervention arm.	12 months

Collaborators and Investigators

• Sponsor: Mbarara University of Science and Technology
• Collaborators: Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Julian Adong, MMed, Mbarara University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: HIV; mHealth; Retention in care; Adolescents and young adults
• Other Study ID Numbers: MUST-2024-06-14; K43TW012640 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No