Mobile Health Intervention for HIV/AIDS

Overseen By Judy Y Tan, Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Antiretrovirals

Disqualifiers: Fear of IPV, Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile health app called LetSync, designed to help people living with HIV manage their treatment and health care. The study evaluates the app's ease of use and effectiveness by assessing its impact on adherence to antiretroviral therapy, which is crucial for managing HIV. Participants will be divided into two groups; one will use the app from the start, while the other will begin later. Ideal candidates for this trial are cisgender men who identify as racial or ethnic minorities, are living with HIV or have a partner with HIV, and have been in a committed relationship for three or more months. Participants must own a smartphone and feel comfortable sharing their HIV status with their partner. This unphased trial offers a unique opportunity to contribute to innovative research that could enhance HIV care for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a mobile health app to support HIV care, so it's likely you can continue your current treatment, but you should confirm with the trial organizers.

What prior data suggests that the LetSync app is safe for use in this trial?

Research has shown that LetSync v1.0 is being tested for its effectiveness in helping couples manage HIV care. Although past studies have not provided direct evidence about its safety, LetSync is a mobile app and does not involve drugs or medical procedures. This suggests it is likely safe to use, as it is simply a smartphone app.

LetSync v2.0, an improved version of the first app, incorporates user feedback to enhance usability. Like the first version, it is also a mobile app, which typically presents a low risk of negative effects.

To date, studies on both versions of LetSync have not reported any harm or safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LetSync mobile health interventions because they offer a novel approach to supporting individuals with HIV/AIDS through digital means. Unlike traditional treatments that focus on medication and regular clinic visits, LetSync v1.0 and v2.0 provide a platform for enhancing patient engagement and adherence to treatment plans via a smartphone app. These interventions aim to improve health outcomes by offering personalized reminders, educational content, and peer support, potentially transforming how patients manage their condition in their daily lives. This digital approach could enhance accessibility and convenience, especially for those unable to frequently visit healthcare facilities.

What evidence suggests that the LetSync app could be effective for improving ART adherence in HIV/AIDS patients?

Research shows that the LetSync app helps people with HIV manage their treatment. It focuses on enabling couples to support each other in managing HIV. Early results suggest that users find the app easy to use and are willing to use it. In this trial, participants in the Intervention Group will use LetSync app v1.0, while those in the Waitlist-Control Group will eventually use LetSync app v2.0. Although specific data on its effectiveness in promoting regular HIV medication adherence is not yet available, the app is designed to help couples stick to their treatment plans. It aims to improve communication and support between partners, which is expected to aid in maintaining treatment adherence. ^{1 2 6 7 8}

Who Is on the Research Team?

Judy Tan, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Partners are eligible if they: Self-identify as a cisgender man, Are age 18 or older, Have a primary relationship partner that is the referring participant, Uses and owns a personal smartphone, Willing and able to provide informed consent

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.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Phase 1

Participants in the intervention arm use LetSync v1.0 for 6 months to assess acceptability and feasibility.

6 months

Intervention Phase 2

Refinements are made to LetSync based on data, and participants in the waitlist-control arm use LetSync v2.0 for 6 months.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including data collection on ART adherence and care engagement.

8 months

What Are the Treatments Tested in This Trial?

Interventions

• LetSync v1.0
• LetSync v2.0

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 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 Group Active Control 1 Intervention

This arm will wait to begin the intervention using the LetSync app v2.0 from T3 to T4, Month 8 to Month 14.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37624634

Acceptability of the LetSync App Wireframes for an mHealth ... We designed the LetSync app wireframes for a mobile health intervention using a couple-centered design approach to improve HIV engagement and treatment.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04951544

LetSync: Pilot Test of Mobile Health (mHealth) Intervention Participants in the intervention arm will use LetSync v1.0 for 6 months and provide acceptability and feasibility data. In the ensuing 2 months, the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10492169/

Acceptability of the LetSync App Wireframes for an ... We designed the LetSync app wireframes for a mobile health intervention using a couple-centered design approach to improve HIV engagement and treatment.

4. mhealth.jmir.org mhealth.jmir.org/2020/11/e17549/

Development and Acceptability of a Tablet-Based App to ... Acceptability of the LetSync App Wireframes for an mHealth Intervention to Improve HIV Care Engagement and Treatment Among Black Partnered ...

5. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT04951544

LetSync: Pilot Test of Mobile Health (mHealth) Intervention Participants in the intervention arm will use LetSync v1.0 for 6 months and provide acceptability and feasibility data. In the ensuing 2 months, ...

6. researchgate.net researchgate.net/publication/353385923_Study_Protocol_A_Pilot_Randomized_Control_Trial_of_A_Dyadic_Mobile_Health_Intervention_for_Black_Sexual-Minority_Male_Couples_with_HIV/fulltext/60f9916e169a1a0103aecf52/Study-Protocol-A-Pilot-Randomized-Control-Trial-of-A-Dyadic-Mobile-Health-Intervention-for-Black-Sexual-Minority-Male-Couples-with-HIV.pdf

Study Protocol: A Pilot Randomized Control Trial of A Dyadic ... Between T1 and T2, we will collect data on acceptability and feasibility and use this to revise LetSync v1.0 and update it to LetSync v2.0. At T3 ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04951544?keyword=%22HIV%2FAIDS%22

LetSync: Pilot Test of Mobile Health (mHealth) Intervention Participants in the intervention arm will use LetSync v1.0 for 6 months and provide acceptability and feasibility data. In the ensuing 2 months, the ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/11/9/e055448.draft-revisions.pdf

BMJ Open is committed to open peer review. As part of this ... ... data ... controlled trial to test the efficacy of LetSync in improving HIV care and treatment outcomes ... LetSync v1.0 and update it to LetSync v2.0. 207.