HIV Infections
Conditions
Keywords
HIV, mHealth, viral load, HIV disparities, HIV care continuum
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).
Interventions
BEHAVIORALAmp
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.
Sponsors
AIDS Healthcare Foundation
Los Angeles LGBT Center
University of Mississippi Medical Center
Wayne State University
Sentient Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety symptoms | 4 months | 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. |
| Substance use | 4 months | 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. |
| HIV and Anti-retroviral knowledge | 4 months | 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. |
| Anti-retroviral medication adherence | 4 months | 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. |
| Adherence barriers | 4 months | 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. |
| Self-Reported Medical Visits | 4 months | 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. |
| HIV status disclosure | 4 months | Self report measures of HIV status disclosure. |
| Time to Treatment Initiation | 4 months | Time in days to treatment initiation from date of diagnosis or referral. |
| Depressive symptoms | 4 months | 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. |
| Medical Visits Record based on EMR | 4 months | Completed medical visits and appointments missed in the past 4 months based on electronic medical record. |
| HIV Self-Management | 4 months | 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. |
| Resilience | 4 months | 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. |
| Discussion of PrEP with Sex Partners | 4 months | 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. |
| Discussion of U=U with Sex Partners | 4 months | 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. |
| Social support | 4 months | 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. |
| Linkage to HIV Care | 4 months | Linkage to HIV care based on two completed medical visits from date of diagnosis or referral. |
Countries
United States
Contacts
Primary ContactJorge A Montoya, PhD
Backup ContactAaron Plant, MPH
Outcome results
None listed