Bruk av telehelse for å bekjempe alkoholmisbruk i HIV-omsorgen (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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02912
- Brown University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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 |
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Alcoholics drinks consumed per week
Tidsramme: 12 months
|
Average number of alcoholic drinks consumed per week over the past 30 days |
12 months
|
|
Alcoholics drinks consumed per week
Tidsramme: 24 months
|
Average number of alcoholic drinks consumed per week over the past 30 days |
24 months
|
|
Number of heavy drinking days
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24 months
|
Viral load test result that indicates HIV virus is detectable in the blood |
24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of the past 30 days adherent to antiretroviral therapy
Tidsramme: 12 months
|
Antiretroviral therapy adherence as assessed by self-report |
12 months
|
|
Proportion of the past 30 days adherent to antiretroviral therapy
Tidsramme: 24 months
|
Antiretroviral therapy adherence as assessed by self-report |
24 months
|
|
Condomless sex with non-steady partners
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Christopher Kahler, PhD, Brown University School of Public Health
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2P01AA019072 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Data in the NDA will be available 6 months after the first participants are recruited and will remain in there.
Tilgangskriterier for IPD-deling
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.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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