Využití telehealth k řešení zneužívání alkoholu v péči o HIV (ReACH3)
This project will test the effects of a telehealth counseling program on reducing alcohol use and improving HIV viral control among people with HIV who drink heavily. In total, 600 heavy drinkers with HIV will be assigned to either (a) a single session of brief counseling on alcohol use or (b) brief counseling plus referral to a telehealth counseling program that includes multiple sessions of counseling by videoconferencing and text messaging support. To understand the effects of the program, participants' alcohol use, HIV outcomes, and health will be assessed over a 2-year period.
Přehled studie
Postavení
Podmínky
Detailní popis
The purpose of the proposed study is to test the real-world effectiveness of the ReACH (Reducing Alcohol use and related Comorbidities in HIV care) telehealth counseling protocol in a pragmatic Hybrid Type 1 effectiveness-implementation randomized trial. The study will recruit 600 heavy-drinking PLWH from four federally-qualified health centers in geographically distinct regions across the U.S, which provide services to over 14,000 PLWH. Upon completing enrollment, participants will be randomized to receive either single-session brief intervention (BI) by phone with referral to local treatment when appropriate or BI plus referral to ReACH telehealth counseling (TC). Participants will complete follow-ups through 24 months after baseline to assess longer-term changes in drinking and health outcomes. The study will test the hypothesis that TC compared to BI will result in (a) reduced number of drinks consumed per week and frequency of heavy drinking and (b) increased odds of having an undetectable viral load at 12- and 24-month follow-ups. Secondary outcomes include self-reported ART adherence, engagement in condomless sex with non-exclusive partners, frequency of other substance use, phosphatidylethanol levels (a biomarker of recent alcohol use), and Veterans Aging Cohort Study index scores. The study also will examine potential moderators of TC effectiveness. As a secondary aim, implementation measures corresponding to aspects of the Dynamic Sustainability Framework will be assessed including implementation outcomes of acceptability, appropriateness, and feasibility guided by Proctor's Implementation Outcomes Framework. Thus, this pragmatic Hybrid Type 1 trial will help establish the real-world effectiveness of the ReACH TC intervention while also providing key implementation-related measures and outcomes that will inform future ReACH TC scale up and sustainability.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Rhode Island
-
Providence, Rhode Island, Spojené státy, 02912
- Brown University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- In care for HIV at one of 4 participating federally qualified health centers, report at least one heavy drinking day (4+ drinks) or average more than 7 drinks per week in the past 30 days
Exclusion Criteria:
- need for supervised alcohol detoxification, as indicated by having a history of severe withdrawal symptoms such as seizures and delirium tremens.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Brief intervention
A brief alcohol intervention lasting about 10 minutes, delivered after the baseline assessments. |
Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking |
|
Experimentální: Brief Intervention plus Telehealth Counseling
A brief alcohol intervention followed by referral to a telehealth counseling protocol including 5 sessions of counseling based on Motivational Interviewing and delivered by videoconferencing. Telehealth counseling extends for up to two years and also includes a text messaging intervention to encourage reductions in drinking. |
Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking 5 sessions of counseling on alcohol use based on Motivational Interviewing. A daily and then monthly text messaging program designed to help participants monitor drinking, set goals, and reinforce successful reduction or abstinence. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Alcoholics drinks consumed per week
Časové okno: 12 months
|
Average number of alcoholic drinks consumed per week over the past 30 days |
12 months
|
|
Alcoholics drinks consumed per week
Časové okno: 24 months
|
Average number of alcoholic drinks consumed per week over the past 30 days |
24 months
|
|
Number of heavy drinking days
Časové okno: 12 months
|
Number of days consuming 4 or more drinks in a day over the past 30 days |
12 months
|
|
Number of heavy drinking days
Časové okno: 24 months
|
Number of days consuming 4 or more drinks in a day over the past 30 days |
24 months
|
|
Proportion of participants with a detectable HIV viral load
Časové okno: 12 months
|
Viral load test result that indicates HIV virus is detectable in the blood |
12 months
|
|
Proportion of participants with a detectable HIV viral load
Časové okno: 24 months
|
Viral load test result that indicates HIV virus is detectable in the blood |
24 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of the past 30 days adherent to antiretroviral therapy
Časové okno: 12 months
|
Antiretroviral therapy adherence as assessed by self-report |
12 months
|
|
Proportion of the past 30 days adherent to antiretroviral therapy
Časové okno: 24 months
|
Antiretroviral therapy adherence as assessed by self-report |
24 months
|
|
Condomless sex with non-steady partners
Časové okno: 12 months
|
Number of days in the past 30 having condomless sex with a non-steady partner |
12 months
|
|
Condomless sex with non-steady partners
Časové okno: 24 months
|
Number of days in the past 30 having condomless sex with a non-steady partner |
24 months
|
|
Veterans Aging Cohort Study (VACS) index total score
Časové okno: 12 months
|
Index of physiologic health calculated using HIV viral load, CD4 cell counts, liver function, creatinine, hemoglobin, platelets, white blood cell count, and height/weight (for body mass index). Higher scores indicate greater physiologic injury and risk for mortality. |
12 months
|
|
Veterans Aging Cohort Study (VACS) index total score
Časové okno: 24 months
|
Index of physiologic health calculated using HIV viral load, CD4 cell counts, liver function, creatinine, hemoglobin, platelets, white blood cell count, and height/weight (for body mass index). Higher scores indicate greater physiologic injury and risk for mortality. |
24 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Christopher Kahler, PhD, Brown University School of Public Health
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2P01AA019072 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Data will be shared through the National Data Archive. We also will post de-identified data used in the primary analyses of trial outcomes after those have been published.
Časový rámec sdílení IPD
Data in the NDA will be available 6 months after the first participants are recruited and will remain in there.
Kritéria přístupu pro sdílení IPD
Investigators can access date in the NDA using the available portal. We will allow access to the outcomes data to all through Brown's data archive once the outcome paper is published.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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