Quantitative and Qualitative Research for "mHealth Program to Support People Living With HIV Across the HIV Care Continuum"

NCT ID: NCT06181916

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2024-12-30

Brief Summary

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The goal of this randomized control trial (RCT) is to assess the effectiveness of Amp, a mobile health (mHealth) app designed to improve outcomes along the HIV care continuum for young Black men who have sex with men (YBMSM) living with HIV. HIV care continuum (linkage to care, retention, viral suppression), quality of life and self efficacy outcomes will be compared after a 4-month period between the intervention group (use Amp and standard of care) and the control group (standard of care only).

Detailed Description

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A maximum of 400 YBMSM participants will be recruited into a randomized control trial from multiple sites across the US to assess the effectiveness of Amp, an mHealth app designed to improve outcomes along the HIV care continuum for YBMSM living with HIV. HIV care continuum (linkage to care, retention, viral suppression), quality of life and self efficacy outcomes will be compared after a 4-month period between the intervention group (use Amp and standard of care) and the control group (standard of care only).

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amp mHealth App

Amp, video-based, virtual support system on an mHealth platform with resources and tools to help YBMSM living with HIV become and stay virally suppressed.

Group Type EXPERIMENTAL

Amp

Intervention Type BEHAVIORAL

Amp is a virtual support system mHealth app that provides information and social support to help young Black men who have sex with men (YBMSM) living with HIV achieve better HIV care continuum outcomes and overall well-being.

Standard of Care

Standard of care (SOS) linkage to care services typically provided by linkage specialists, health navigators, or case workers.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Amp

Amp is a virtual support system mHealth app that provides information and social support to help young Black men who have sex with men (YBMSM) living with HIV achieve better HIV care continuum outcomes and overall well-being.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* MSM AND;
* Black or African-American AND;
* 18-29 years old AND;
* Diagnosed with HIV during the study period (From April 1, 2024-August 31 2024) OR;
* Diagnosed with HIV in the year prior to the study period (April 1, 2023-March 31, 2024) OR;
* HIV positive but not linked into care OR;
* Fallen out of care (no HIV care visits within last 6 months) OR;
* Currently in care but NOT virally suppressed (viral load ≥200 copies/mL)
* AND, Online access through a mobile device AND;
* Ability to read and write English.

Exclusion Criteria

* Currently participating in another HIV care continuum or mobile health intervention
* Plan to leave the study site within the study period
* Cognitively impaired at recruitment or baseline testing
* Has a self-reported health issue that prohibits them from participating
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AIDS Healthcare Foundation

OTHER

Sponsor Role collaborator

Los Angeles LGBT Center

OTHER

Sponsor Role collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role collaborator

Sentient Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorge A Montoya, PhD

Role: PRINCIPAL_INVESTIGATOR

Sentient Research

Locations

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Sentient Research

West Covina, California, United States

Site Status

Countries

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United States

Central Contacts

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Jorge A Montoya, PhD

Role: CONTACT

2138648959

Aaron Plant, MPH

Role: CONTACT

2134480660

Facility Contacts

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Jorge A Montoya, PhD

Role: primary

213-864-8959

Aaron Plant, MPH

Role: backup

2134480660

Other Identifiers

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9043

Identifier Type: -

Identifier Source: org_study_id

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