Clinical trial NCT05958017: reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
Official title: reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: Substance use
Adherence to Anti-Retroviral Therapy
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-07-24
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if reSET, an FDA authorized mobile therapeutic, is effective in treating stimulant use disorder and helping keep HIV viral load suppression stable among men who have sex with men who are living with HIV and have a stimulant use disorder.


Eligibility criteria: Inclusion Criteria:

* Identifies as male or as a female, who was assigned male sex at birth and who has not undergone any hormonal Treatment;
* Reports past year anal intercourse with a male, or identifies as a man who has sex with other men;
* Age 18 or older (reSET is only approved for use with adults);
* Person Living with HIV who is an Aids Healthcare Foundation (AHF) patient at one of the four metro areas: Atlanta, Dallas/Fort Worth, Fort Lauderdale, Los Angeles;
* Screens positive for a moderate or severe stimulant use disorder in the last 3-months using the Alcohol, Smoking and Substance Involvement Test (ASSIST);
* Reports that he is not currently in drug Treatment;
* Currently has an active Antiretroviral Therapy prescription and reports \< 90% HIV Tx adherence on the 3-item Wilson measure in the past 30 days69;
* Has an iPhone, Android smartphone or a tablet computer;
* Can obtain access to stable internet with privacy acceptable to the participant at least twice a week\*
* Indicates being able to understand English (reSET is only available in English; can be read or heard);
* Consents to participation in the study.

Exclusion Criteria:

* Otherwise eligible participants will be excluded if they appear to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis).
* Patients who can benefit from another type of Treatment because of severity of Stimulant Use Disorder or opiate use disorder will be referred appropriately.
* We will exclude persons residing in criminal justice facilities because they will not have access to a mobile device as required by reSET.

Primary outcomes:
measure: Change in days of stimulant use as measured by Timeline FollowBack
timeFrame: 3, 9 and 15 months.
Secondary outcomes:
measure: Proportion of subjects with viral suppression
timeFrame: 3, 9 and 15 months.
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Jose Szapocznik, PhD
role: PRINCIPAL_INVESTIGATOR
References: