Adolescent BehaviorREMAINNCT06545968
A Social Media Intervention to Improve Retention in Care for Adolescents and Young Adults With HIV in Uganda
A study testing A social media based intervention in people with Adolescent Behavior, run by Mbarara University of Science and Technology at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior
- What is being tested?
- A social media based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUganda
- Study dates
- 25 Oct 2024to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- For counsellors Inclusion criteria
- Clinic counsellors who are ≥18 years
- Clinic counsellors who have worked at the HIV clinic for ≥ 1 year
- 1) Inability to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site, 1 recruiting
- Recruiting
Mbarara University of Science and Technology
Mbarara
Julian Adong, MMed, +256 755553595, jadong@must.ac.ug
About this study
Official title: 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.
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.
- Conditions
- Adolescent Behavior
- Being tested
- A social media based intervention
- Keywords
- Adolescents and young adults, HIV, mHealth, Retention in care
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A social media based interventionBehavioural
WatsApp-based modules to influence retention in care behaviour
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | These are the participants who will be randomised to receive the intervention at the start of the study. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start25 Oct 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Julian Adong, MMed, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545968
- Sponsor's protocol ID
- MUST-2024-06-14
- Other IDs
- K43TW012640
- Acronym
- REMAIN
- Status last verified
- May 2025
- First submitted
- 25 Jul 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention Through mHealth for Adolescents and Young Adults With HIV in Care
- ClinicalTrials.gov ID
- NCT06545968
- Acronym / sponsor ID
- REMAIN / MUST-2024-06-14
- Conditions
- Adolescent Behavior
- Keywords
- Adolescents and young adults, HIV, mHealth, Retention in care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: A social media based interventionThese are the participants who will be randomised to receive the intervention at the start of the study. |
| 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- For counsellors Inclusion criteria
- Clinic counsellors who are ≥18 years
- Clinic counsellors who have worked at the HIV clinic for ≥ 1 year
- 1) Inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A social media based interventionWatsApp-based modules to influence retention in care behaviour | Behavioural | Intervention arm |
Primary outcome
The primary intervention outcome will be the acceptability, feasibility of the intervention.
Time frame: 12 months
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.
1 secondary outcome
Retention
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
Related trials for Adolescent Behavior
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julian Adong, MMed principal investigator
Mbarara University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A social media based intervention in people with Adolescent Behavior, run by Mbarara University of Science and Technology at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julian Adong, MMed (+256 755553595, jadong@must.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary intervention outcome will be the acceptability, feasibility of the intervention. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.