Quantitative and Qualitative Research for "A Video-Based Mobile Health Program to Support People Living With HIV Across the HIV Care Continuum"
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Sentient Research
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Viral Suppression
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 29 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Standard of Care
Standard of care (SOS) linkage to care services typically provided by linkage specialists, health navigators, or case workers.
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.
Intervention: Amp (Behavioral)
Outcomes
Primary Outcomes
Viral Suppression
Time Frame: 4 months
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.
HIV Stigma
Time Frame: 4 months
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.
Secondary Outcomes
- Self-Reported Medical Visits(4 months)
- HIV status disclosure(4 months)
- HIV and Anti-retroviral knowledge(4 months)
- Anxiety symptoms(4 months)
- Time to Treatment Initiation(4 months)
- Discussion of PrEP with Sex Partners(4 months)
- Anti-retroviral medication adherence(4 months)
- Adherence barriers(4 months)
- Linkage to HIV Care(4 months)
- Social support(4 months)
- Depressive symptoms(4 months)
- Discussion of U=U with Sex Partners(4 months)
- Medical Visits Record based on EMR(4 months)
- Substance use(4 months)
- HIV Self-Management(4 months)
- Resilience(4 months)