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Smartphone App for Adolescent HIV Treatment Adherence

Q: How many participants have been admitted to this trial at present?

Affirmative. The information accessible on clinicaltrials.gov suggests that this medical trial is presently enrolling participants, having first been advertised on June 21st 2022 and updated the same day. It requires 50 patients to be recruited from a single site.

Q: Does the research include participants of advanced age?

This trial is limited to those aged 15-19. For younger patients, there are 161 trials available while elderly individuals have access to 359 clinical studies.

Q: Are there any unfilled slots available to participants in this investigation?

Affirmative. According to the particulars on clinicaltrials.gov, this investigation is presently engaging volunteers. This research project was first published on June 21st 2022 and has been amended since then; it seeks 50 participants at 1 medical centre.

Q: May I be accepted into this clinical investigation?

This clinical trial is searching for a cohort of 50 <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-infected teenagers between 15 and 19 years old to participate. In order to be considered, participants must also meet the following qualifications: demonstrate familiarity with their HIV status, have been born with the virus, not repeat any grades in school more than once, feel comfortable working with an English app interface, never participated in our MASI study previously, take medications prescribed by a doctor for the treatment of said infection, attend regular schools instead of special skills institutions; possess a smartphone that can download applications; and commit to residing within Cape Town's limits over the course of six months or longer.

N/A

Waitlist Available

Led By Marta I Mulawa, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has been prescribed medication to treat HIV

Age >= 15 years and <= 21 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months

Awards & highlights

Study Summary

This trial will test a smartphone app designed to help improve ART adherence and social support for adolescents living with HIV.

Who is the study for?

This trial is for South African adolescents aged 15-21 living with HIV who have a smartphone and are comfortable using apps in English. They should be on HIV medication, not planning to move from Cape Town soon, and haven't failed more than one grade or been involved in prior testing of the MASI app.Check my eligibility

What is being tested?

The study tests 'MASI', an app designed to help young people with HIV take their medicine regularly. It includes features like information resources, goal setting, social support networks, and self-monitoring tools to encourage habit formation.See study design

What are the potential side effects?

Since this trial involves a smartphone app rather than medication, traditional side effects aren't expected. However, participants may experience increased screen time or privacy concerns related to app usage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am taking medication for HIV.

Select...

I am between 15 and 21 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intervention acceptability: Composite score from adapted system usability scale

Intervention feasibility: Number of days participants log in to the app as recorded by app backend paradata

Intervention feasibility: Number of days participants log medications using the app as recorded by app backend paradata

+1 more

Secondary outcome measures

Adherence to ART, as measured by 30-day recall of missed doses

Perceived social support and social isolation using adapted Medical Outcomes Study Social Support Survey (MOS-SS)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MASIExperimental Treatment4 Interventions

Participants randomized to the intervention condition will receive access to MASI, the smartphone app customized for this study. MASI is an adapted version of HealthMpowerment, a theory-based smartphone app with features including an anonymous interactive discussion forum, a medication and adherence tracker, a platform to ask questions to an expert, a section with engaging activities (including quizzes, self-assessments, and goal-setting activities), and a multi-media resource center.

Group II: Information-only version of MASIActive Control1 Intervention

Participants randomized to the control condition will an information-only version of MASI which will include the Resources feature and the home page.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Social Support

2022

Completed Phase 2

~3440

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Cape TownOTHER

245 Previous Clinical Trials

541,268 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,782 Previous Clinical Trials

2,689,057 Total Patients Enrolled

University of North CarolinaOTHER

166 Previous Clinical Trials

1,449,557 Total Patients Enrolled

Media Library

MASI Clinical Trial Eligibility Overview. Trial Name: NCT04661878 — N/A

Human Immunodeficiency Virus Infection Research Study Groups: MASI, Information-only version of MASI

Human Immunodeficiency Virus Infection Clinical Trial 2023: MASI Highlights & Side Effects. Trial Name: NCT04661878 — N/A

MASI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04661878 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been admitted to this trial at present?

"Affirmative. The information accessible on clinicaltrials.gov suggests that this medical trial is presently enrolling participants, having first been advertised on June 21st 2022 and updated the same day. It requires 50 patients to be recruited from a single site."

Answered by AI

Does the research include participants of advanced age?

"This trial is limited to those aged 15-19. For younger patients, there are 161 trials available while elderly individuals have access to 359 clinical studies."

Answered by AI

Are there any unfilled slots available to participants in this investigation?

"Affirmative. According to the particulars on clinicaltrials.gov, this investigation is presently engaging volunteers. This research project was first published on June 21st 2022 and has been amended since then; it seeks 50 participants at 1 medical centre."

Answered by AI

May I be accepted into this clinical investigation?

"This clinical trial is searching for a cohort of 50 HIV-infected teenagers between 15 and 19 years old to participate. In order to be considered, participants must also meet the following qualifications: demonstrate familiarity with their HIV status, have been born with the virus, not repeat any grades in school more than once, feel comfortable working with an English app interface, never participated in our MASI study previously, take medications prescribed by a doctor for the treatment of said infection, attend regular schools instead of special skills institutions; possess a smartphone that can download applications; and commit to residing within Cape Town's limits over the course of six months or longer."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV

2022. "Piloting a Smartphone App to Improve Treatment Adherence Among South African Adolescents Living With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04661878.