The Less is More Study

Официальное название

Novel Extensions of Alcohol Contingency Management in People Living With HIV

Обзор

In this project, the investigators will implement innovations to extend use of Contingency Management (CM) to facilitate alcohol use reduction among people living with HIV (PLWH). The investigators' approach to extending CM will use mobile health (mHealth) tools including a smartphone breathalyzer device with accompanying app and a wrist worn alcohol biosensor. Participants will be engaged in mobile facilitated CM for 30-60 days with follow-up out to 6 months.

Вмешательства

• Поведенческое Counseling
  Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning
• Поведенческое mHealth
  Participants will engage with an application designed to gamify drinking reduction.
• Поведенческое Counseling
  Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning.

Первичные конечные точки

• Percent days abstinent via smartphone breathalyzer readings [Срок оценки: Baseline to 30 Days]
• Predict percent days abstinent via smartphone breathalyzer readings based on risk factors. [Срок оценки: Baseline to 30 Days]
• Perceived value and ease of use of novel contingency management strategies to reduce alcohol consumption. [Срок оценки: 30 Days to 60 Days]
• Drinking reduction through Contingency Management will predict non-drinking outcomes [Срок оценки: Baseline to 90 days]

Вторичные конечные точки (1)

• Percent days abstinent via wrist biosensor readings [Срок оценки: Baseline to 60 Days]

Критерии участия

Критерии включения

• Frequent alcohol use in the past 30 days based on responses on the Timeline Followback (TLFB; Sobell and Sobell, 2003)
• HIV positive
• Fluency in English
• Willingness to attempt alcohol abstinence for at least 30 days and then to attempt alcohol use on fewer days than at baseline after that
• Willingness to use smartphone applications and biosensor devices (i.e., breathalyzer device and wrist sensor) for alcohol use reduction purposes in the study. If participants do not have a compatible smartphone to use, they will be loaned one by the study

Критерии исключения

• Psychiatric conditions that would interfere with participation in the study
• Current alcohol withdrawal as indicated by a score of 8 or higher on the Clinical Institute Withdrawal Scale (CIWA; Sullivan et al., 1989) or lifetime history of medically assisted detoxification
• Two positive breath alcohol concentration (BrAC) readings (i.e., > 0.00%) at an in-person screening appointment. After participants blow their first positive BrAC, they will be allowed to reschedule and participate at another time, however if they blow a second positive BrAC, they will be excluded from this study and offered referrals for alcohol treatment.
• Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
• Psychosis or other severe psychiatric disability
• Pregnancy, nursing or lack of reliable birth control use for women who have not yet reached menopause

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• University of Miami — Coral Gables
• University of Florida — Gainesville

Идентификаторы

NCT: NCT05153811 · CED000000577 · P01AA029543 · PRO00035889 · OCR41499 · CED000000577

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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