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

HIV Infections Clinical Trial

— VSS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06181916
• Other study ID #: 9043
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 29, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: Sentient Research
• Contact: Jorge A Montoya, PhD
• Phone: 2138648959
• Email: jorge[@]sentientresearch.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Sentient Research	West Covina	California

Sponsors (5)

Lead Sponsor	Collaborator
Sentient Research	AIDS Healthcare Foundation, Los Angeles LGBT Center, University of Mississippi Medical Center, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	HIV status disclosure	Self report measures of HIV status disclosure.	4 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to Treatment Initiation	Time in days to treatment initiation from date of diagnosis or referral.	4 months
Secondary	Linkage to HIV Care	Linkage to HIV care based on two completed medical visits from date of diagnosis or referral.	4 months
Secondary	Medical Visits Record based on EMR	Completed medical visits and appointments missed in the past 4 months based on electronic medical record.	4 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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