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Behavioural Intervention
Mobile Health Intervention for HIV/AIDS
N/A
Recruiting
Led By Judy Y Tan, Ph.D.
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights
Study Summary
This trial will test a new mobile health intervention called LetSync to see if it is acceptable and feasible, and if it improves retention in care and antiretroviral adherence.
Who is the study for?
This trial is for cisgender men over 18 in a committed relationship, who are racial/ethnic minorities living with HIV or have a partner who is. They must own and use a smartphone and be willing to consent to the study. It's not for those fearing intimate partner violence from participating or unable to disclose their HIV status.Check my eligibility
What is being tested?
The LetSync mHealth intervention is being tested on couples where at least one partner has HIV. The study will see if using the app helps them stay on track with their treatment and care. Participants will first try version 1.0, then some will test an updated version after feedback.See study design
What are the potential side effects?
Since this trial involves an mHealth app rather than medication, traditional side effects aren't expected; however, participants may experience privacy concerns or stress related to adherence monitoring.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Levels of Antiretroviral (ARV) concentration in dried blood spot (DBS) samples
Presence of Antiretroviral (ARV) medication in urine sample
Self-reported measure I of antiretroviral therapy (ART) adherence
+2 moreSecondary outcome measures
Acceptability of or Satisfaction in using LetSync app v1.0
Feasibility or usability of LetSync app v1.0 (how easy or convenient is v1.0 to use)
Self-reported care engagement
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
This arm will start the intervention using LetSync app v1.0 from T1 to T4, baseline/Month 0 to Month 14.
Group II: Waitlist-Control GroupActive Control1 Intervention
This arm will wait to begin the intervention using the LetSync app v2.0 from T3 to T4, Month 8 to Month 14.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,311 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,688,947 Total Patients Enrolled
Judy Y Tan, Ph.D.Principal InvestigatorUniversity of California, San Francisco
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are afraid that participating in the study could result in violence from your partner, you cannot or will not tell your primary partner about your HIV status, or you have severe memory problems that would make it hard for you to understand what is involved in the study.You can participate in the study if you are 18 years or older, identify as a racial/ethnic minority, identify as a cisgender man, are HIV-positive or have a partner who is HIV-positive, have a committed primary relationship for more than 3 months, own a smartphone, and are willing to give consent.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist-Control Group
- Group 2: Intervention Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still an opportunity for participants to enroll in this research?
"Confirmed. The clinical trial, which was initially posted November 15th 2022, is still inviting applicants per the most recent update on October 4th 2022."
Answered by AI
What effects does this study aim to produce?
"Over the course of 14 months, this clinical trial aims to assess self-reported care engagement. Secondary objectives include examining the usability (Feasibility) and acceptability of LetSync App v1.0 and v2.0 via a 10 item Likert scale questionnaire at baseline (T1), 6 months(T2), 8 months (T3) and 12 months(T4). The investigators will use these data to calculate mean scores for Feasibility/Acceptability; higher scores indicating greater user satisfaction with the app version in question."
Answered by AI
How many participants is the clinical trial recruiting?
"Affirmative. Per information sourced from clinicaltrials.gov, this research project has been actively recruiting patients since November 15th 2022 and was last edited on October 4th 2022. The study is aiming to enrol 160 individuals in a single location."
Answered by AI
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