Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda
Game Changers: Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda
This randomized controlled pilot study of the "Game Changers" program will:
- Assess the feasibility and acceptability of implementing an HIV prevention advocacy intervention with people living with HIV who are in HIV care, and who will be trained to be advocates of HIV protective behaviors within their social networks.
- Assess preliminary intervention effects on a) protective behavior of the HIV-positive clients (condom use, partner concurrency/number of partners, engagement in HIV care, ART adherence); and b) diffusion of prevention messages across the network, as assessed by the content and extent of communication with network members about protective behaviors (condom use, partner concurrency/number of partners, HIV testing, engagement in HIV care, circumcision), HIV disclosure, and HIV stigma.
- Explore characteristics of HIV-positive clients who more effectively engage in prevention advocacy (in terms of socio-demographics, network characteristics, and network position and type of alters receiving advocacy).
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Studietype
Registrering (Faktiske)
Registrering
Fase
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Kampala, Uganda
- Infectious Diseases Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria (People living with HIV):
- 18+ years old
- In HIV care for > 1 year
- Having disclosed serostatus to at least one person
Inclusion Criteria (Social network members):
- 18+ years old
- Referred by a patient participant because they are family members, friends, or other people in patients' social network
- knows patient participant's serostatus
Exclusion Criteria:
- Individuals who meet the inclusion criteria above will be eligible to participate, and no other exclusion criteria apply.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
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Eksperimentell: Game Changers Intervention
Game Changers is an intervention that aims to empower and mobilize people living with HIV to be agents for HIV prevention and behavioral change in their social networks.
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Game Changers is an intervention that aims to empower and mobilize PLHA to be agents for HIV prevention and behavioral change in their social networks.
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Ingen inngripen: Control
The control group will receive standard of care during the intervention assessment period.
All control participants will be offered the Game Changers program once all assessments for the primary study outcomes have been completed.
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Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Engagement HIV Prevention Advocacy
Tidsramme: Past 3 months, measured at baseline and 5 and 8 months post-baseline
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Self-reported communication with social network members about protective behaviors.
This is a composite of 14 survey items rated on a scale of 1 (low level of communication) to 5 (high level of communication).
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Past 3 months, measured at baseline and 5 and 8 months post-baseline
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Sexual Risk Behavior Among Alters
Tidsramme: Measured at baseline and 5 and 8 months post-baseline
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Increased percentage of self-reported condom use with main partner in past 3 months
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Measured at baseline and 5 and 8 months post-baseline
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Change in HIV Treatment Adherence
Tidsramme: Measured at baseline and 5 and 8 months post-baseline
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Increased antiretroviral treatment adherence (self-reported % doses taken in past month)
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Measured at baseline and 5 and 8 months post-baseline
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Change in Internalized HIV Stigma
Tidsramme: Measured at baseline and 5 and 8 months post-baseline
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Decreased rates of internalized HIV-related stigma on Internalized AIDS Stigma Scale (range=1-5, higher values = high stigma)
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Measured at baseline and 5 and 8 months post-baseline
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Number of Participants Who Have Reported Their HIV Status to Their Main Partner
Tidsramme: Measured at baseline and 5 and 8 months post-baseline
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Increased self-reported rates of HIV status disclosure: Participants were asked if they had disclosed their HIV-serostatus to their main partner or spouse (yes/no).
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Measured at baseline and 5 and 8 months post-baseline
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Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Samarbeidspartnere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Studiestart
Primær fullføring (Faktiske)
Primær fullføring
Studiet fullført (Faktiske)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
Andre studie-ID-numre
- R34MH111460 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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