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

April 22, 2024 updated by: Sentient Research

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
No Intervention: Standard of Care
Standard of care (SOS) linkage to care services typically provided by linkage specialists, health navigators, or case workers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 months
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.
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HIV and Anti-retroviral knowledge
Time Frame: 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.
4 months
Anti-retroviral medication adherence
Time Frame: 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.
4 months
Adherence barriers
Time Frame: 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.
4 months
Self-Reported Medical Visits
Time Frame: 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.
4 months
HIV status disclosure
Time Frame: 4 months
Self report measures of HIV status disclosure.
4 months
Social support
Time Frame: 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.
4 months
Depressive symptoms
Time Frame: 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.
4 months
Anxiety symptoms
Time Frame: 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.
4 months
Substance use
Time Frame: 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.
4 months
Time to Treatment Initiation
Time Frame: 4 months
Time in days to treatment initiation from date of diagnosis or referral.
4 months
Linkage to HIV Care
Time Frame: 4 months
Linkage to HIV care based on two completed medical visits from date of diagnosis or referral.
4 months
Medical Visits Record based on EMR
Time Frame: 4 months
Completed medical visits and appointments missed in the past 4 months based on electronic medical record.
4 months
HIV Self-Management
Time Frame: 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.
4 months
Resilience
Time Frame: 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.
4 months
Discussion of PrEP with Sex Partners
Time Frame: 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.
4 months
Discussion of U=U with Sex Partners
Time Frame: 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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sentient Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wayne State University
University of Mississippi Medical Center
AIDS Healthcare Foundation
Los Angeles LGBT Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jorge A Montoya, PhD, Sentient Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9043 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This is currently undecided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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