Supporting Treatment Adherence for Resilience and Thriving (START)

Study Overview
=================
Brief 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.

Official Title
-----------------
Supporting Treatment Adherence for Resilience and Thriving

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

Intervention / Treatment
-----------------
* Behavioral: START mHealth Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Assigned male at birth; Identifies as male; Age 18 or older; Reads and speaks English; Continental US residency; Reports ever having had anal sex with a man; Self-reported HIV diagnosis for 3 or more months and currently taking anti-retroviral therapy (ART) Reports a detectable viral load during past year OR no viral load test in the past 10+ months OR reports < 90% adherence to ART; 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); Has an iPhone or Android smartphone; Is willing to participate in an mHealth intervention Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: START mHealth Intervention<br>Participants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization. | Behavioral: START mHealth Intervention<br>* 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.<br>|
| No Intervention: Website referrals<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detectable HIV Viral Load | Proportion of participants with a viral load > 300 copies/mL from dried blood spot samples | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detectable Viral Load | Proportion of participants with a viral load > 300 copies/mL from dried blood spot samples | 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). | 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 | 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. | 12 Months |