HIV InfectionsVSSNCT06181916
Quantitative and Qualitative Research for "mHealth Program to Support People Living With HIV Across the HIV Care Continuum"
A study testing Amp in people with HIV Infections, run by Sentient Research at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Amp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sentient Research
West Covina, California, 91790
Jorge A Montoya, PhD, 213-864-8959, jorge@sentientresearch.net
Aaron Plant, MPH, 2134480660, aaron@sentientresearch.net
About this study
Official title: 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).
Read the 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).
- Conditions
- HIV Infections
- Being tested
- Amp
- Keywords
- HIV, mHealth, viral load, HIV disparities, HIV care continuum
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmpBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Amp mHealth App | Experimental | 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. Receives: Behavioral: Amp |
| Standard of Care | No intervention | Standard of care (SOS) linkage to care services typically provided by linkage specialists, health navigators, or case workers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 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.
Measured: 4 months
Secondary outcomes (16)
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.
Measured: 4 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.
Measured: 4 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.
Measured: 4 months
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.
Measured: 4 months
HIV status disclosure
Self report measures of HIV status disclosure.
Measured: 4 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.
Measured: 4 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.
Measured: 4 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.
Measured: 4 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.
Measured: 4 months
Time to Treatment Initiation
Time in days to treatment initiation from date of diagnosis or referral.
Measured: 4 months
Linkage to HIV Care
Linkage to HIV care based on two completed medical visits from date of diagnosis or referral.
Measured: 4 months
Medical Visits Record based on EMR
Completed medical visits and appointments missed in the past 4 months based on electronic medical record.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start29 Apr 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sentient Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AIDS Healthcare Foundation, Los Angeles LGBT Center, University of Mississippi Medical Center, Wayne State University
- Responsible party
- Sponsor
- Investigators
- Jorge A Montoya, PhD, Principal investigator, Sentient Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181916
- Sponsor's protocol ID
- 9043
- Acronym
- VSS
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is currently undecided.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative and Qualitative Research for "A Video-Based Mobile Health Program to Support People Living With HIV Across the HIV Care Continuum"
- ClinicalTrials.gov ID
- NCT06181916
- Acronym / sponsor ID
- VSS / 9043
- Conditions
- HIV Infections
- Keywords
- HIV, mHealth, viral load, HIV disparities, HIV care continuum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sentient ResearchIndustry (pharma, biotech, devices)
- Collaborators
- AIDS Healthcare Foundation, Los Angeles LGBT Center, University of Mississippi Medical Center, Wayne State University
- Study start
- 29 Apr 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amp mHealth App | Experimental | Behavioral: AmpAmp, video-based, virtual support system on an mHealth platform with resources and tools to help YBMSM living with HIV become and stay virally suppressed. |
| Standard of Care | No intervention | –Standard of care (SOS) linkage to care services typically provided by linkage specialists, health navigators, or case workers. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmpAmp 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. | Behavioural | Amp mHealth App |
Primary outcome
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.
16 secondary outcomes
HIV and Anti-retroviral knowledge
Time frame: 4 months
Anti-retroviral medication adherence
Time frame: 4 months
Adherence barriers
Time frame: 4 months
Self-Reported Medical Visits
Time frame: 4 months
HIV status disclosure
Time frame: 4 months
Social support
Time frame: 4 months
Depressive symptoms
Time frame: 4 months
Anxiety symptoms
Time frame: 4 months
Substance use
Time frame: 4 months
Time to Treatment Initiation
Time frame: 4 months
Linkage to HIV Care
Time frame: 4 months
Medical Visits Record based on EMR
Time frame: 4 months
HIV Self-Management
Time frame: 4 months
Resilience
Time frame: 4 months
Discussion of PrEP with Sex Partners
Time frame: 4 months
Discussion of U=U with Sex Partners
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Undecided. This is currently undecided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge A Montoya, PhD principal investigator
Sentient Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amp in people with HIV Infections, run by Sentient Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge A Montoya, PhD (2138648959, jorge@sentientresearch.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Suppression (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.