Clinical trial NCT06181916: Quantitative and Qualitative Research for "mHealth Program to Support People Living With HIV Across the HIV Care Continuum"
Official title: Quantitative and Qualitative Research for "A Video-Based Mobile Health Program to Support People Living With HIV Across the HIV Care Continuum"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: HIV
mHealth
viral load
HIV disparities
HIV care continuum
Lead sponsor: Sentient Research
Sponsor class: INDUSTRY
Collaborators: name: AIDS Healthcare Foundation
name: Los Angeles LGBT Center
name: University of Mississippi Medical Center
name: Wayne State University
First posted: 2023-12-26
Enrollment: 300
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Viral Suppression
timeFrame: 4 months
measure: HIV Stigma
timeFrame: 4 months
Secondary outcomes:
measure: HIV and Anti-retroviral knowledge
timeFrame: 4 months
measure: Anti-retroviral medication adherence
timeFrame: 4 months
measure: Adherence barriers
timeFrame: 4 months
measure: Self-Reported Medical Visits
timeFrame: 4 months
measure: HIV status disclosure
timeFrame: 4 months
measure: Social support
timeFrame: 4 months
measure: Depressive symptoms
timeFrame: 4 months
measure: Anxiety symptoms
timeFrame: 4 months
measure: Substance use
timeFrame: 4 months
measure: Time to Treatment Initiation
timeFrame: 4 months
measure: Linkage to HIV Care
timeFrame: 4 months
measure: Medical Visits Record based on EMR
timeFrame: 4 months
measure: HIV Self-Management
timeFrame: 4 months
measure: Resilience
timeFrame: 4 months
measure: Discussion of PrEP with Sex Partners
timeFrame: 4 months
measure: Discussion of U=U with Sex Partners
timeFrame: 4 months
Other outcomes:
Locations:
city: West Covina
country: United States
facility: Sentient Research
state: California
Study officials:
affiliation: Sentient Research
name: Jorge A Montoya, PhD
role: PRINCIPAL_INVESTIGATOR
References: