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

Study Overview
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Brief Summary
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The goal of this randomized control trial (RCT) is 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, cluster of differentiation 4, viral load, viral suppression), quality of life and self efficacy outcomes will be compared after a 5-month period between the intervention group (use Amp and standard of care) and the control group (standard of care only).

Detailed Description
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A maximum of 400 YBMSM participants will be recruited into a randomized control trial from multiple sites across the US (via AIDS Healthcare Foundation) 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, cluster of differentiation 4, viral load, viral suppression), quality of life and self efficacy outcomes will be compared after a 5-month period between the intervention group (use Amp and standard of care) and the control group (standard of care only).

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Amp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MSM Black or African-American 18-29 years old Recently diagnosed with HIV (within 12 months), diagnosed but not in care, or in care but not virally suppressed (viral load ≥200 copies/mL). Fallen out of care Online access through a mobile device 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amp mHealth App<br>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<br>* 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.<br>|
| No Intervention: Standard of Care<br>Standard of care (SOS) linkage to care services typically provided by linkage specialists, health navigators, or case workers. | |

What is the study measuring?
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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. | 5 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. | 5 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. | 5 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. | 5 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. | 5 months | 
| Medical Visits | Self-report measures of medical visits completes and appointments missed in the past 5 months. Response range is from 0 to 30 or more times. A lower selection is the better outcome. | 5 months | 
| HIV status disclosure | Self report measures of HIV status disclosure. | 5 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. | 5 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. | 5 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. | 5 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. | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, mHealth, viral load, HIV disparities, HIV care continuum