Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM
3. april 2021 opdateret af: Kathryn Chavez, Boston University Charles River Campus
Feasibility of an mHealth + Brief Intervention for Heavy Drinking African American and Latino MSM: A Pilot Study
Randomized controlled pilot trial to test the feasibility and efficacy of a brief intervention with app-based messaging to reduce sexual risk behavior and heavy drinking among Black/African American and Hispanic/Latino MSM.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
This study seeks to develop and provide an initial test of a brief intervention to reduce alcohol use and sex risk behavior among Black and Latino men who have sex with men [BLMSM].
The study seeks to recruit BLMSM who are non-monogamous, not currently on pre-exposure prophylaxis [PrEP], have engaged in condomless anal intercourse over the past 6 months, who have engaged in heavy drinking defined as >14 drinks per week or at least 1 heavy drinking episode (5+ drinks on a single occasion) in the past month.
All participants will complete baseline measures about past month behavior and if eligible will be assigned to the intervention condition or an assessment only condition.
The intervention consists of a single brief video-conferencing intervention coupled with 4 weeks of mobile-messaging related to individualized goals about alcohol use and sexual behavior.
Follow-up assessments are scheduled for 4 weeks after baseline (upon completion of the mobile-messaging component of the intervention) and 2 months after baseline.
Primary outcomes are feasibility and acceptability of the intervention and mobile-messaging components.
Secondary outcomes are changes in frequency of condomless anal intercourse and heavy drinking episodes.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Kathryn E Chavez, MA
- Telefonnummer: 3237173311
- E-mail: kathryn.eve.chavez@gmail.com
Undersøgelse Kontakt Backup
- Navn: Tibor P Palfai, PhD
- Telefonnummer: 6173539345
- E-mail: palfai@Bu.edu
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Boston University
-
Kontakt:
- Tibor P Palfai, PhD
- Telefonnummer: 617-353-9345
- E-mail: palfai@bu.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år til 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Black/African American or Latino/Hispanic
- At least one heavy drinking episode in past month
- At least one episode of condomless anal intercourse with another man in the past 6 months
- Own a smartphone
- English speaking
Exclusion Criteria:
- HIV+
- Currently on PrEP
- Monogamous/exclusive relationship
- Past or current treatment for alcohol (past 3 years)
- Current or past psychiatric treatment (past 3 months)
- Diagnosis of Bipolar Disorder or Schizophrenia
- Brief Michigan Alcoholism Screening Test score >5
- Lifetime diagnosis of substance use disorder
- ASSIST score of >/=27 for any individual substance
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Brief mHealth Intervention + mobile messaging
The intervention is a brief, motivational video-conferencing intervention followed by four weeks of app-based, interactive mobile messages
|
The intervention is a brief, motivational video-conferencing intervention followed by four weeks of app-based, interactive mobile messages to reduce heavy episodic drinking and sexual risk behavior (condomless anal intercourse) among Black/African American and Hispanic/Latino men who have sex with men
|
|
Ingen indgriben: Assessment Only
This is an assessment only condition.
No intervention following completion of baseline surveys will be administered.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Modified Daily Drinking Questionnaire - Heavy Drinking Episodes
Tidsramme: Past 30 days
|
Number of heavy drinking episodes NIAAA criteria (5+ drinks)
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Past 30 days
|
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Sexual Behavior - Extended Survey - Condomless Anal Intercourse
Tidsramme: Past 30 days
|
Frequency of condomless anal intercourse.
This is an open ended question where the Participant reports the frequency of condomless anal intercourse over the past 30 days.
|
Past 30 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Goal Systems Assessment Battery - Alcohol
Tidsramme: Past 30 days
|
Ratings of self-regulatory capacities related to reducing alcohol use.
Items are 5-point Likert scale.
There are 4 subscales utilized including planning, monitoring, self-efficacy and value.
Higher scores indicates better outcomes.
|
Past 30 days
|
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Goal Systems Assessment Battery - Condom Use
Tidsramme: Past 30 days
|
Ratings of self-regulatory capacities related to using condoms.
Items are 5-point Likert scale.
There are 4 subscales utilized including planning, monitoring, self-efficacy and value.
Higher scores indicates better outcomes.
|
Past 30 days
|
|
Client Satisfaction Questionnaire
Tidsramme: 2 months post-baseline
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8-item Client Satisfaction Questionnaire answered on a 4-point scale.
Mean scale score is 1-4.
Higher scores reflect a better outcome.
|
2 months post-baseline
|
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Intervention Acceptability Ratings
Tidsramme: 2 months post-baseline
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10-item Acceptability Measure of the overall intervention answered on a 5-point Likert scale (strongly disagree to strongly agree) used to assess the acceptability of the video-conferencing brief intervention and the mobile messages.
Mean scale range is 1-5.
Higher scores reflect a better outcome.
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2 months post-baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Kathryn E Chavez, MA, Boston University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. april 2021
Primær færdiggørelse (Forventet)
1. juni 2021
Studieafslutning (Forventet)
1. juli 2021
Datoer for studieregistrering
Først indsendt
23. marts 2021
Først indsendt, der opfyldte QC-kriterier
26. marts 2021
Først opslået (Faktiske)
29. marts 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 5479E
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Uafklaret
IPD-planbeskrivelse
under discussion
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