Supporting Treatment Adherence for Resilience and Thriving (START)

HIV-1-infection Clinical Trial

— START  

Official title:

Supporting Treatment Adherence for Resilience and Thriving

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140876
• Other study ID #: 20190578
• Secondary ID: R01DA049843
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2023
• Source: Florida International University
• Contact: Adam W Carrico, PhD
• Phone: 305-348-7887
• Email: acarrico[@]fiu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

1. Assigned male at birth;

2. Identifies as male;

3. Age 18 or older;

4. Reads and speaks English;

5. Continental US residency;

6. Reports ever having had anal sex with a man;

7. Self-reported HIV diagnosis for 3 or more months and currently taking anti-retroviral therapy (ART)

8. Reports a detectable viral load during past year OR no viral load test in the past 10+ months OR reports < 90% adherence to ART;

9. Screens positive for a moderate or severe stimulant use disorder in the past 3 months with an abbreviated version of the National Institute on Drug Abuse (NIDA)-modified Alcohol, Smoking and Substance. Involvement Screening Test (ASSIST);

10. Has an iPhone or Android smartphone;

11. Is willing to participate in an mHealth intervention

Exclusion Criteria:

1. HIV-negative or never tested for HIV;

2. HIV-positive men without a current ART prescription;

3. Does not return a viable DBS specimen at baseline for viral load testing

4. Not a sexual minority man

Related Conditions & MeSH terms

• Adherence, Medication
• HIV-1-infection
• Stimulant Use

Intervention

Behavioral:
• START mHealth Intervention
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.

Locations

Country	Name	City	State
United States	University of MIami Miller School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detectable HIV Viral Load	Proportion of participants with a viral load > 300 copies/mL from dried blood spot samples	6 Months
Secondary	Detectable Viral Load	Proportion of participants with a viral load > 300 copies/mL from dried blood spot samples	12 Months
Secondary	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).	12 Months
Secondary	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	12 Months
Secondary	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.	12 Months