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

Sentient Research

Status: Not yet enrolling

Conditions: HIV Infections

Treatments: Behavioral: Amp

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06181916

9043

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 300 estimated patients

Sex: Male

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Amp mHealth App

Experimental group

Description:

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.

Treatment:

Behavioral: Amp

Standard of Care

No Intervention group

Description:

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