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

Quantitative and Qualitative Research for "A Video-Based Mobile Health Program to Support People Living With HIV Across the HIV Care Continuum"

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).

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Amp

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge A Montoya, PhD; Phone Number: 2138648959; Email: jorge@sentientresearch.net
• Study Contact Backup: Name: Aaron Plant, MPH; Phone Number: 2134480660; Email: aaron@sentientresearch.net

Study Locations

• United States
  • California
    • West Covina, California, United States, 91790
      • Sentient Research
      • Contact: Aaron Plant, MPH; Phone Number: 2134480660; Email: aaron@sentientresearch.net
      • Contact: Jorge A Montoya, PhD; Phone Number: 213-864-8959; Email: jorge@sentientresearch.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Standard of Care; Standard of care (SOS) linkage to care services typically provided by linkage specialists, health navigators, or case workers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV and Anti-retroviral knowledge	Composite agreement score on 7 knowledge statements around Anti-retroviral, viral suppression, and U=U. Agreement from 1 (Strongly Disagree) to 5 (Strongly Agree). Higher scores indicate greater knowledge (better outcome). Range of composite scores will be from 7 to 35.	4 months
Anti-retroviral medication adherence	Self-report measures of ART adherence based on type of prescription (injectable or pill), length of time taking medication, and time since last does in moths and/or days.	4 months
Adherence barriers	Reasons checked for not taking ART medication from a list of 13 reasons and an "other" write in. More reasons checked indicate more barriers. Little to no barriers is the better outcome. Composite score range for reasons is from 0 to 13. A lower score is the better outcome.	4 months
Self-Reported Medical Visits	Self-reported completed medical visits and appointments missed in the past 4 months. Response range is from "0" to "30 or more times". A lower selection is the better outcome.	4 months
HIV status disclosure	Self report measures of HIV status disclosure.	4 months
Social support	Composite agreement score on 7 statements for social support. Agreement from 1 (Strongly Disagree) to 5 (Strongly Agree). Higher scores indicate higher social support (better outcome). Range of composite scores will be from 7 to 35.	4 months
Depressive symptoms	Composite frequency score on 6 depression symptoms from the Brief Symptom Inventory 18 (BSI-18). From 1 (Not at all) to 4 (Nearly every day). Lower scores indicate lower frequency of symptoms (better outcome). Range of composite scores will be from 6 to 24.	4 months
Anxiety symptoms	Composite frequency score on 5 anxiety symptoms from the Brief Symptom Inventory 18 (BSI-18). From 1 (Not at all) to 4 (Nearly every day). Lower scores indicate lower frequency of symptoms (better outcome). Range of composite scores will be from 5 to 20.	4 months
Substance use	Composite score on self-report measures of substance use for 10 substances and an "other" write-in from 1 (Never) to 5 (Every day). Range of scores from 10 to 55. A lower score is the better outcome.	4 months
Time to Treatment Initiation	Time in days to treatment initiation from date of diagnosis or referral.	4 months
Linkage to HIV Care	Linkage to HIV care based on two completed medical visits from date of diagnosis or referral.	4 months
Medical Visits Record based on EMR	Completed medical visits and appointments missed in the past 4 months based on electronic medical record.	4 months
HIV Self-Management	Composite agreement score on 12 HIV self-management agreement statements. Agreement from 1 (Strongly Disagree) to 5 (Strongly Agree). Lower scores indicate lower self-management and higher scores indicate higher HIV self-management stigma (better outcome). Range of composite scores will be from 12 to 60.	4 months
Resilience	Composite agreement score on resilience agreement statements. Agreement from 1 (Strongly Disagree) to 5 (Strongly Agree). Lower scores indicate lower resilience and higher scores indicate higher resilience (better outcome). Range of composite score from 8 to 40.	4 months
Discussion of PrEP with Sex Partners	Frequency on a 5-point scale from "never" to "all of the time" on discussing PrEP with an HIV negative or unknown status partner in the last 4 months.	4 months
Discussion of U=U with Sex Partners	Frequency on a 5-point scale from "never" to "all of the time" on discussing U=U with an HIV negative or unknown status partner in the last 4 months.	4 months

Collaborators and Investigators

• Sponsor: Sentient Research
• Collaborators: Wayne State University; University of Mississippi Medical Center; AIDS Healthcare Foundation; Los Angeles LGBT Center
• Investigators: Principal Investigator: Jorge A Montoya, PhD, Sentient Research

Study record dates

Study Major Dates

• Study Start (Estimated): April 29, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HIV; mHealth; viral load; HIV care continuum; HIV disparities
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: 9043 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is currently undecided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No