HealthMPowerment App for HIV Prevention

Overseen By Stephanie Wallace, MD, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: PrEP

Disqualifiers: HIV positive, Inability to consent

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

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app designed to help Black adolescents and young adults in Alabama adhere to their PrEP medication, which prevents HIV. The researchers aim to determine if the HealthMPowerment App is a practical and acceptable tool for supporting these individuals and their adult supporters in managing PrEP. Participants will use the app for six months to track medication and communicate with their support persons. Suitable candidates include African Americans in Alabama recommended to take PrEP, particularly those with experiences such as sex with multiple partners or a recent sexually transmitted infection.

As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for HIV prevention in the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the HealthMPowerment App is safe for use in promoting PrEP adherence?

Research has shown that the HealthMPowerment App helps reduce risky behaviors related to HIV. While specific safety data for the app is not available, digital tools are typically low-risk. The app provides information and support to help individuals adhere to their PrEP medication plan, which prevents HIV. As a digital tool rather than a drug or medical device, it poses minimal risk to users. People generally find such digital tools easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HealthMPowerment App is unique because it aims to enhance HIV prevention by leveraging digital technology to support communication and medication tracking. Unlike traditional methods that often rely on in-person consultations and manual adherence tracking, this app facilitates continuous, virtual interaction between young adults and their support networks. Researchers are excited about this approach because it could significantly improve adherence to PrEP medications through real-time reminders and easy access to support, potentially reducing new HIV infections more effectively than current options.

What evidence suggests that the HealthMPowerment App is effective for promoting PrEP adherence?

Research has shown that the HealthMPowerment (HMP) app helps reduce HIV risk behaviors among young Black men who have sex with men. The app effectively improves care engagement and manages HIV in those who have the virus. In this trial, participants will use the app to assist Black adolescents and young adults in adhering to PrEP, a medication that prevents HIV. Although its effect on PrEP adherence remains uncertain, the app's emphasis on building community and changing behaviors appears promising. It encourages healthier habits through learning and interaction. Overall, early evidence suggests the app could support PrEP adherence effectively. ^{1 3 4 6 7}

Who Is on the Research Team?

Samantha Hill, MD, MPH

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for African American adolescents and young adults (AYAs) living in Alabama who might benefit from PrEP due to their sexual activities or having had a sexually transmitted infection recently. They need an adult support person over 21 years old. Those with HIV or unable to consent are excluded.

Inclusion Criteria

African Americans living in the state of Alabama

I am at high risk for HIV due to my sexual activities or recent STI.

I am over 21 and support a Black young person aged 14-21.

Exclusion Criteria

HIV positive

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the enhanced HMP app for 6 months to facilitate communication and track PrEP adherence

6 months

Data collection at 1, 3, and 6 months

Follow-up

Participants are monitored for app usability, communication effectiveness, and medication adherence

1 month

What Are the Treatments Tested in This Trial?

Interventions

• HealthMPowerment App

Trial Overview The study is testing the HealthMPowerment (HMP) App, which has been enhanced based on Social Cognitive Theory, to see if it's practical and acceptable for promoting PrEP adherence among Black AYAs and their adult supporters.

How Is the Trial Designed?

Group I: AYA group Experimental Treatment 1 Intervention

All enrolled participants (AYAs and support persons) will receive a demonstration of the app including all of its features. All participants will use the app for 6 months. Each dyad of participants will instructed to use the app to communicate with each other and AYAs will be instructed to use the app to keep track of their PrEP. Data from the medication tracker will be collected at 1-, 3-, and 6-months

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The MyPEEPS Mobile app, designed to deliver HIV prevention information to young men aged 13-24, received positive usability feedback from both experts and end users, indicating it is user-friendly and effective for its target audience.

End users rated the app's usability with a mean score of 1.63, suggesting strong acceptance, and expert evaluations identified usability issues that will be addressed before further testing in a pilot study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health Intervention for HIV Prevention Among Racially and Ethnically Diverse Young Men: Usability Evaluation. Cho, H., Powell, D., Pichon, A., et al.[2022]

A mobile health app was developed specifically for older Black women with HIV, based on qualitative feedback from 10 participants aged 50 and older, highlighting their needs and preferences.

The app aims to enhance support and resources for this demographic, and its development involved community input, indicating a collaborative approach to addressing the unique challenges faced by older women living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Community Engagement to Develop a Mobile Health Application for Older Women With HIV Infection. Njie-Carr, VPS., Jones-Parker, H., Massey, C., et al.[2022]

The development of HealthMpowerment.org, an online HIV/STI prevention intervention for young Black men who have sex with men (BMSM), involved extensive input from the target audience through focus groups and interviews, ensuring the intervention is tailored to their needs.

Preliminary results indicate high satisfaction and usability of the website, suggesting that the Internet is an effective platform for delivering risk reduction messages to this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HealthMpowerment.org: development of a theory-based HIV/STI website for young black MSM. Hightow-Weidman, LB., Fowler, B., Kibe, J., et al.[2022]

The PositiveLinks (PL) mHealth app has shown promise in improving care engagement and viral load suppression among people with HIV, indicating its potential effectiveness as a supportive tool in chronic disease management.

An interim analysis of implementation at four Ryan White HIV clinics identified key facilitators, such as the app's alignment with clinic needs and effective training resources, as well as barriers like Wi-Fi access and patient privacy concerns, which will help optimize future implementation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Implementation Strategy to Expand Mobile Health Use in HIV Care Settings: Rapid Evaluation Study Using the Consolidated Framework for Implementation Research. Cohn, WF., Canan, CE., Knight, S., et al.[2021]

A systematic search identified only 11 out of 621 mobile apps that effectively support the uptake and adherence of PrEP, indicating a significant gap in available resources for at-risk individuals.

The evaluated apps showed moderate effectiveness in facilitating PrEP use by providing essential information and resources, and they received an acceptable quality rating, suggesting they could help increase PrEP uptake among those at risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic evaluation of mobile apps to improve the uptake of and adherence to HIV pre-exposure prophylaxis. Sharpe, JD., Kamara, MT.[2019]

The Mpowerment (MP) intervention significantly increased HIV testing and self-efficacy for safer sex among 298 young men who have sex with men (MSM) of color over a 3-year period, indicating its effectiveness in promoting safer sexual behaviors.

Participants reported higher self-acceptance as MSM and improved perceptions of positive social norms regarding safer sex after the intervention, although the reduction in condomless anal/vaginal sex was only noted at the first follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of Mpowerment on Individual-Level HIV Risk Behavior, Testing, and Psychosocial Factors Among Young MSM of Color: The Monitoring and Evaluation of MP (MEM) Project. Shelley, G., Williams, W., Uhl, G., et al.[2022]

Citations

1. healthmpowerment.org healthmpowerment.org/healthmpowerment-history-risk-reduction-findings/

The History of HealthMpowerment Evidence-based HealthMpowerment (HMP) platform reduces HIV risk behaviors in young Black MSM. View our proven findings from ongoing research.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4501897/

Building Community Though a Mobile-Optimized, Online ... Retention was 100%. Mean age was 26 years, 60% were HIV-infected, 87% earned <$21,000, and 67% were uninsured. Despite the small sample size ...

3. withpower.com withpower.com/trial/phase-human-immunodeficiency-virus-hiv-infections-2026-5b8a6

HealthMPowerment App for HIV Prevention The PositiveLinks (PL) mHealth app has shown promise in improving care engagement and viral load suppression among people with HIV, indicating its potential ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/81/NCT03678181/Prot_SAP_000.pdf

HealthMpowerment Stigma A gap in knowledge exists regarding how participants' engagement with mHealth interventions is linked to HIV prevention and care outcomes.88,89 Paradata can ...

5. jmir.org jmir.org/2020/5/e15977/

The Effectiveness of Electronic Health Interventions for ... Objective: This study aimed to conduct a meta-analysis of the effectiveness of eHealth technology–based interventions for promoting HIV- ...

6. healthmpowerment.org healthmpowerment.org/

Home - HealthMpowerment (HMP) Leveraging a holistic view to health, HMP content covers topics ranging from traditional physical health such as HIV and STI prevention and treatment ...

7. mhealth.jmir.org mhealth.jmir.org/2017/4/e46/

Technology Use and Preferences for Mobile Phone–Based ... Conclusions: Mobile phone–based HIV prevention has the potential to increase engagement with HIV prevention and treatment resources among BYMSM.