PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
Personalized Normative Feedback to Decrease Unhealthy Alcohol Use and Increase HIV Prevention Behavior Among Youth and Young Adults in Rural Ugandan Schools
Studieoversikt
Status
Detaljert beskrivelse
New approaches to HIV prevention and treatment among young people in HIV-endemic African countries will be needed to meet the 95-95-95 UNAIDS targets. Several HIV/STI transmission-related behaviors are more likely to occur with heavy alcohol use including engaging in condomless sex, partner concurrency, and transactional sex. Heavy alcohol use is a prevalent and strong modifiable risk factor for HIV transmission risk behavior in Uganda. One way to target behaviors related to HIV/STI-transmission, alcohol misuse, and their intersection is to target misperceived norms, which are directly linked to personal health behavior.
This study employs a randomized controlled trial to evaluate how providing accurate information about local descriptive (i.e., behavioral) and injunctive (i.e., attitudinal) norms to adoloescents and young adults affect HIV/STI transmission behaviors and alcohol misuse. Participants are randomly assigned to one of four treatment arms: (1) a control condition without any normative information; (2) a treatment condition in which they are reminded of what they thought local HIV/STI transmission behavior engagement rates were in their school and then receive accurate information about rates of HIV/STI transmission behavior engagement and prevention in their school; (3) a treatment condition in which they are reminded of what they thought alcohol misuse rates were in their school and then receive accurate information about rates of alcohol misuse behavior in their school; or (4) a treatment condition in which they are reminded of what they thought alcohol misuse rates and local HIV/STI transmission behavior engagement rates were in their school and then receive both types of accurate normative information in their school.
The study assesses how providing this type of personalized normative feedback within cohort-based data collection affects alcohol use and engagement in HIV/STI transmission behaviors, such as condomless sex, transactional sex, and drug/alcohol use during sexual activity. Outcomes will be measured through self-reported data at two time points within 12 months through two follow-up survey waves, which will be compared to baseline self-reported data before exposure to the PNF treatment. We hypothesize that providing accurate information about alcohol misuse and HIV/STI transmission and prevention behavior engagement rates will decrease alcohol misuse, decrease engagement in HIV/STI-transmission behavior and increase prevention behavior (primary outcomes), and improve the accuracy of estimated school level rates of engagement in HIV/STI transmission behaviors and alcohol misuse in the future (secondary outcome).
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jessica M. Perkins, Ph.D.
- Telefonnummer: 585-750-6694
- E-post: jessica.m.perkins@vanderbilt.edu
Studer Kontakt Backup
- Navn: Sarah E Sowell, B.A.
- Telefonnummer: 982-832-8104
- E-post: sarah.e.sowell@vanderbilt.edu
Studiesteder
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Uganda
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Mbarara, Uganda, Uganda
- Mbarara University of Science and Technology
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Ta kontakt med:
- Charles Baguma, MPH
- Telefonnummer: 256-077-564-1558
- E-post: Cbaguma@mustresearch.org
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- All students enrolled in Kinoni High School, Kinoni Girls Secondary School, or Rugando Technical Institute, 13-25 years of age
Exclusion Criteria:
- Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Arm 1: No normative feedback
Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version does not provide any normative feedback information. |
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Eksperimentell: Arm 2: PNF-HIV norms only
Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version provides personalized normative feedback with descriptive and injunctive norms information about school level rates of engagement in HIV-transmission and prevention behaviors. |
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. This treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of engagement in HIV-transmission behavior engagement in their school. Participants are then provided with the true rates of HIV-transmission behavior engagement in their school, and notification that this is consistent across demographic groups. Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol misuse, which will be compared to baseline data collected before treatment. |
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Eksperimentell: Arm 3: PNF-Alcohol use norms only
Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission and prevention behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version provides personalized normative feedback with descriptive and injunctive norms information about alcohol use. |
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. This treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of rates of alcohol use in their school. Participants are then provided with information about the true rates of alcohol use in their school. Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol use, which will be compared to baseline data collected before treatment. |
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Eksperimentell: Arm 4: PNF-HIV transmission and alcohol use norms
Each version of the questionnaire has similar questions about personal alcohol (mis)use and engagement in HIV/STI transmission behavior and perceived norms about other students' alcohol misuse and engagement in HIV/STI transmission and prevention behavior. The content of the prompt presented prior to the questions varies based on treatment arm. This version provides personalized normative feedback with both school level descriptive and injunctive norms surrounding alcohol use and engagement in HIV/STI transmission and prevention behaviors. |
As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The fourth treatment is a survey-based questionnaire with a prompt stating the participant's previously provided estimate of HIV transmission behavior engagement and alcohol use in their school. Participants are then provided with information about the true rates of both HIV transmission behavior engagement and alcohol use in their school. Two follow-up waves of survey collection over the 12 months following the PNF will collect information about engagement in HIV/STI transmission and prevention behaviors and alcohol use, which will be compared to baseline data collected before treatment. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Self-reported engagement in partner concurrency
Tidsramme: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported recent engagement in condomless sex
Tidsramme: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported engagement in alcohol use
Tidsramme: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Measured through the participant's self reported AUDIT-C score.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported HIV testing
Tidsramme: Assessed at 3 months and 9 months after the intervention.
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Assessed at 3 months and 9 months after the intervention.
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Self-reported alcohol/drug use during sex
Tidsramme: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Self-reported engagement in transactional sex
Tidsramme: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported PrEP willingness/stigma/interest
Tidsramme: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported engagement in other sexual behaviors
Tidsramme: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported perception of school-level rates of HIV/STI transmission and prevention behaviors and attitudes
Tidsramme: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Self-reported perception of school-level rates of engagement in alcohol use
Tidsramme: Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Assessed at 3 months and 9 months after the intervention via follow-up survey.
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Blodbårne infeksjoner
- Urogenitale sykdommer
- Kjønnssykdommer
- Patologiske prosesser
- Sykdomsattributter
- Sykdommer i immunsystemet
- Infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Drikkeatferd
- Langsomme virussykdommer
- HIV-infeksjoner
- Patologiske tilstander, tegn og symptomer
- Oppførsel
- Alkoholdrikking
- Ervervet immunsviktsyndrom
- Seksuelt overførbare sykdommer
- Organiske kjemikalier
- Alkoholer
- Etanol
Andre studie-ID-numre
- 250304
- R01AA031936 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
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