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

NCT06181916 | Unknown

• 1 other identifier: 9043
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

HIV Infections

Keywords

HIV; mHealth; viral load; HIV disparities; HIV care continuum

Outcome Measures

Primary Outcomes (2)

• Viral Suppression

  HIV viral load is less than 200 copies per microliter based on labs in patient EMR data. Viral suppression (viral load is less than 200 copies per microliter) is the better outcome.

  4 months

• HIV Stigma

  Composite agreement score on 13 HIV related stigma statements as measured by items derived from the Berger HIV Stigma Scale. Agreement from 1 (Strongly Disagree) to 5 (Strongly Agree). Lower scores indicate lower stigma (better outcome). Range of composite scores will be from 13 to 65.

  4 months

Secondary Outcomes (16)

• HIV and Anti-retroviral knowledge

  4 months

• Anti-retroviral medication adherence

  4 months

• Adherence barriers

  4 months

• Self-Reported Medical Visits

  4 months

• HIV status disclosure

  4 months

Study Arms (2)

Amp mHealth App

EXPERIMENTAL

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.

Behavioral: Amp

Standard of Care

NO INTERVENTION

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

Interventions

Amp 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.

Amp mHealth App

Eligibility Criteria

• Age: 18 Years - 29 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• MSM AND;
• Black or African-American AND;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sentient Research: lead
• AIDS Healthcare Foundation: collaborator
• Los Angeles LGBT Center: collaborator
• University of Mississippi Medical Center: collaborator
• Wayne State University: collaborator

Study Sites (1)

Sentient Research

West Covina, California, 91790, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Adenosine Monophosphate

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Jorge A Montoya, PhD

  Sentient Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge A Montoya, PhD

CONTACT

2138648959; jorge@sentientresearch.net

Aaron Plant, MPH

CONTACT

2134480660; aaron@sentientresearch.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 26, 2023
• Study Start: April 29, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 24, 2024

Record last verified: 2023-12

Locations

US (1)