ClinicalTrials.gg
RecruitingNCT06545968REMAINUpdated May 18, 2025

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

An interventional study of A social media based intervention in Adolescent Behavior, sponsored by Mbarara University of Science and Technology. Recruiting at 1 site in Uganda. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by Mbarara University of Science and Technology · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Adolescent Behavior

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Keywords

  • Adolescents and young adults
  • HIV
  • mHealth
  • Retention in care
03

In context

Adolescent Behavior

305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.

This study's planned enrollment of 105 is below the median of 172 across 256 interventional studies indexed under Adolescent Behavior.

Browse Adolescent Behavior studies →

Lead sponsor

Mbarara University of Science and Technology is the lead sponsor of 31 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

The eligibility criteria is as follows:

For adolescents and young adults with (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
105 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralA social media based intervention

    WatsApp-based modules to influence retention in care behaviour

06

What researchers measure

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.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Jul 2027, 33 months after the start.

Of 195 non-industry interventional studies with no phase under Adolescent Behavior, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 33 months is above that.

Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 8 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2024
First posted
Aug 9, 2024
StartActual
Oct 25, 2024
Primary completionEst.
Jul 31, 2027
CompletionEst.
Jan 30, 2028
Last update
May 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06545968
Lead sponsor
Mbarara University of Science and Technology
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Oct 25, 2024
Primary completion
Jul 31, 2027 (estimated)
Completion
Jan 30, 2028 (estimated)
Last update
May 18, 2025

Study contacts

Julian Adong, MMed
Contact
jadong@must.ac.ug
+256 755553595
Julian Adong, MMed
principal investigator · Mbarara University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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