Adherence, MedicationSTARTNCT05140876
Supporting Treatment Adherence for Resilience and Thriving (START)
A study testing START mHealth Intervention in people with Adherence, Medication and HIV-1-infection, run by Florida International University at 1 site in United States.
Trial summary
This Phase II randomized controlled trial is testing the efficacy of a cell phone application called START for helping men who use stimulants like methamphetamine to get the most out of their HIV treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adherence, Medication, HIV-1-infection, Stimulant Use
- What is being tested?
- START mHealth Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 31 Jul 2025
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- HIV-negative or never tested for HIV;
- HIV-positive men without a current ART prescription;
- Does not return a viable DBS specimen at baseline for viral load testing
- Not a sexual minority man
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: Supporting Treatment Adherence for Resilience and Thriving
This Phase II randomized controlled trial is testing the efficacy of a cell phone application called START for helping men who use stimulants like methamphetamine to get the most out of their HIV treatment.
- Conditions
- Adherence, Medication, HIV-1-infection, Stimulant Use
- Being tested
- START mHealth Intervention
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
START mHealth InterventionBehavioural
The START mHealth intervention is a mobile application that will be downloaded by participants through their mobile phones. The application targets information, motivation, and behavioral skills relevant to ART adherence. Participants will have access to this application for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| START mHealth Intervention | Experimental | Participants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization. Receives: Behavioral: START mHealth Intervention |
| Website referrals | No intervention | Participants in this condition will receive no intervention and will have access to a website with resources related to substance use disorder treatment and HIV treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unsuppressed HIV Viral Load
Proportion of participants with a viral load > 300 copies/mL from dried blood spot samples
Measured: 6 Months
Secondary outcomes (4)
Unsuppressed Viral Load
Proportion of participants with a viral load > 300 copies/mL from dried blood spot samples
Measured: 12 Months
Self-Reported Stimulant Use Severity
The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) provides validated composite scores indexing the severity of cocaine and amphetamine use (Mild = 0-3; Moderate = 4-26; Severe = 27 or greater).
Measured: 12 Months
Self-Reported Anti-Retroviral Therapy (ART) Adherence
Participants will rate on a visual analogue scale the percentage (0% meaning no adherence to 100% meaning complete adherence) of ART medications that they took in the past 30 days
Measured: 12 Months
Positive Affect
Mean positive affect score as measured by the modified Differential Emotions Scale (Range 0-104) with higher scores being indicative of higher positive affect.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start15 Jun 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adherence, MedicationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Adam Carrico, PhD, Florida International University
- Investigators
- Adam W Carrico, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140876
- Sponsor's protocol ID
- 20190578
- Other IDs
- R01DA049843
- Acronym
- START
- Status last verified
- Feb 2026
- First submitted
- 15 Nov 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davis-Ewart L, Atkins L, Ghanooni D, Diaz JE, Chuku CC, Balise R, DeVries BA, Miller-Perusse M, Ackley Iii D, Moskowitz JT, McCollister K, Fardone E, Hirshfield S, Horvath KJ, Carrico AW. Supporting treatment adherence for resilience and thriving (START): protocol for a mHealth randomized controlled trial. BMC Public Health. 2024 Aug 29;24(1):2350. doi: 10.1186/s12889-024-19745-7.
PubMed 39210314
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Treatment Adherence for Resilience and Thriving
- ClinicalTrials.gov ID
- NCT05140876
- Acronym / sponsor ID
- START / 20190578
- Conditions
- Adherence, Medication, HIV-1-infection, Stimulant Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 2 Dec 2021 (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.
This Phase II randomized controlled trial is testing the efficacy of a cell phone application called START for helping men who use stimulants like methamphetamine to get the most out of their HIV treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| START mHealth Intervention | Experimental | Behavioral: START mHealth InterventionParticipants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization. |
| Website referrals | No intervention | –Participants in this condition will receive no intervention and will have access to a website with resources related to substance use disorder treatment and HIV treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- HIV-negative or never tested for HIV;
- HIV-positive men without a current ART prescription;
- Does not return a viable DBS specimen at baseline for viral load testing
- Not a sexual minority man
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 |
|---|---|---|
| START mHealth InterventionThe START mHealth intervention is a mobile application that will be downloaded by participants through their mobile phones. The application targets information, motivation, and behavioral skills relevant to ART adherence. Participants will have access to this application for 6 months. | Behavioural | START mHealth Intervention |
Primary outcome
Unsuppressed HIV Viral Load
Time frame: 6 Months
Proportion of participants with a viral load > 300 copies/mL from dried blood spot samples
4 secondary outcomes
Unsuppressed Viral Load
Time frame: 12 Months
Self-Reported Stimulant Use Severity
Time frame: 12 Months
Self-Reported Anti-Retroviral Therapy (ART) Adherence
Time frame: 12 Months
Positive Affect
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 39210314Davis-Ewart L, Atkins L, Ghanooni D, Diaz JE, Chuku CC, Balise R, DeVries BA, Miller-Perusse M, Ackley Iii D, Moskowitz JT, McCollister K, Fardone E, Hirshfield S, Horvath KJ, Carrico AW. Supporting treatment adherence for resilience and thriving (START): protocol for a mHealth randomized controlled trial. BMC Public Health. 2024 Aug 29;24(1):2350. doi: 10.1186/s12889-024-19745-7.
- Individual participant dataSharing planned: No
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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.
Adam W Carrico, PhD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing START mHealth Intervention in people with Adherence, Medication and HIV-1-infection, run by Florida International University 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 0 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: finished, as of the sponsor's last update on 17 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unsuppressed HIV Viral Load (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05140876, which also lists 1 linked publication.
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 17 Feb 2026.