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- Klinische proef NCT03435497
Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda
27 mei 2020 bijgewerkt door: RAND
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).
Studie Overzicht
Gedetailleerde beschrijving
People living with HIV (PLWH) have a critical role to play in HIV prevention, not only in the context of Prevention for Positives and Treatment as Prevention, but as powerful change agents for HIV protective behaviors among others.
Our research suggests that as PLWH receive HIV treatment and restore their health and functioning, many are motivated to protect their loved ones and engage in prevention advocacy (i.e., to encourage friends and family to seek HIV testing and treatment, and to reduce risk behavior); however, the quality of this advocacy is hampered by challenges related to message content, style and timing of delivery, and selection of advocacy recipients.
With effective advocacy training, mobilizing PLWH to be change agents within their social networks has the potential to be a "game changer" for HIV prevention, particularly in high prevalence settings such as Uganda, where virtually every family is touched by someone living with HIV.
Drawing upon theoretical frameworks for network-based interventions, such as theories of social diffusion, cognitive consistency, and social influence, the proposed study will develop and pilot test "Game Changers"-- an intervention that aims to empower and mobilize PLWH to be agents for HIV prevention and behavioral change in their social networks.
In Phase 1, separate focus groups of PLWH and members of their social networks (family and friends) were conducted to explore barriers to and facilitators of mobilizing clients to advocate for HIV prevention, perceptions on how advocacy could be most effective in motivating behavior change, and how to best structure the intervention and its content.
In Phase 2 findings from Phase 1 and network-based intervention models were used to develop the structure and content of an intervention designed to help clients cope with stigma, manage their disease, live positively, and develop motivation and skills for HIV disclosure and prevention advocacy.
In Phase 3 a pilot group intervention will be conducted in a controlled trial of 96 clients, with 48 randomly assigned to receive the intervention and 48 to the wait-list control.
Assessments will be administered to all participants at baseline, 5 months later, and again 8 months after baseline, after which the control group will receive the intervention (but not the interviews).
PLWH interviews and social network assessments will examine intervention effects on protective behaviors of the participant (condom use, HIV treatment adherence), and 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.
At the end of the intervention period a focus group with program participants will be conducted to get feedback on the intervention.
To help understand how participation in the program might affect health, date of HIV diagnosis, last two CD4 counts and HIV viral loads, and prescribed HIV medications will be obtained from PLWH participant medical charts.
Participants (about 15/arm) will be asked to recruit up to 3 alters each, who know the participant's serostatus, to be interviewed to assess their HIV protective behaviors (e.g., condom use) and receipt of prevention advocacy from the intervention participant.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
99
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Kampala, Oeganda
- Infectious Diseases Institute
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Engagement HIV Prevention Advocacy
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Sexual Risk Behavior Among Alters
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
16 april 2018
Primaire voltooiing (Werkelijk)
31 juli 2019
Studie voltooiing (Werkelijk)
31 juli 2019
Studieregistratiedata
Eerst ingediend
8 februari 2018
Eerst ingediend dat voldeed aan de QC-criteria
14 februari 2018
Eerst geplaatst (Werkelijk)
19 februari 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 juni 2020
Laatste update ingediend die voldeed aan QC-criteria
27 mei 2020
Laatst geverifieerd
1 mei 2020
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- R34MH111460 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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Imaging Biometrics, LLCxCuresVerkrijgbaarGlioblastoom | Glioblastoom Multiforme | Refractair glioblastoomVerenigde Staten
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Gamaleya Research Institute of Epidemiology and...Government of the city of Moscow; CRO: Crocus Medical BVOnbekendCovid19-preventieRussische Federatie
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Gamaleya Research Institute of Epidemiology and...Russian Direct Investment Fund; CRO: iPharmaOnbekend
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Gamaleya Research Institute of Epidemiology and...Acellena Contract Drug Research and DevelopmentVoltooidPreventieve immunisatie COVID-19Russische Federatie
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Dr. Reddy's Laboratories LimitedGamaleya Research Institute of Epidemiology and Microbiology, Health Ministry... en andere medewerkersActief, niet wervend
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Gamaleya Research Institute of Epidemiology and...OnbekendCoronavirusbesmettingRussische Federatie
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Gamaleya Research Institute of Epidemiology and...Nog niet aan het wervenCOVID-19 | SARS-CoV-2 acute luchtwegaandoening