NCT06545968

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Oct 2024Jan 2028

First Submitted

Initial submission to the registry

July 25, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 25, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

2.8 years

First QC Date

July 25, 2024

Last Update Submit

May 14, 2025

Conditions

Keywords

Adolescents and young adultsHIVmHealthRetention in care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Retention

    12 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

These are the participants who will be randomised to receive the intervention at the start of the study.

Behavioral: A social media based intervention

Wait list control arm

NO INTERVENTION

These are participants who will not receive the intervention initially, but will move to the intervention arm after 6 months of follow-up

Interventions

WatsApp-based modules to influence retention in care behaviour

Intervention arm

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Clinic counsellors who are ≥18 years
  • Clinic counsellors who have worked at the HIV clinic for ≥ 1 year
  • \) Inability to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

RECRUITING

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Julian Adong, MMed

    Mbarara University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Adong, MMed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The proposed project is a mixed-methods prospective cohort study of adolescents and young adults with HIV, clinic counsellors. The study will design and test a social media mHealth intervention to improve retention in care for adolescents and young adults with HIV.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2024

First Posted

August 9, 2024

Study Start

October 25, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

January 30, 2028

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations