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Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

27 mai 2020 mis à jour par: 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:

  1. 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.
  2. 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.
  3. 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).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

99

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Kampala, Ouganda
        • Infectious Diseases Institute

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Engagement HIV Prevention Advocacy
Délai: Past 3 months, measured at baseline and 5 and 8 months post-baseline
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).
Past 3 months, measured at baseline and 5 and 8 months post-baseline

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Sexual Risk Behavior Among Alters
Délai: Measured at baseline and 5 and 8 months post-baseline
Increased percentage of self-reported condom use with main partner in past 3 months
Measured at baseline and 5 and 8 months post-baseline
Change in HIV Treatment Adherence
Délai: Measured at baseline and 5 and 8 months post-baseline
Increased antiretroviral treatment adherence (self-reported % doses taken in past month)
Measured at baseline and 5 and 8 months post-baseline
Change in Internalized HIV Stigma
Délai: Measured at baseline and 5 and 8 months post-baseline
Decreased rates of internalized HIV-related stigma on Internalized AIDS Stigma Scale (range=1-5, higher values = high stigma)
Measured at baseline and 5 and 8 months post-baseline
Number of Participants Who Have Reported Their HIV Status to Their Main Partner
Délai: Measured at baseline and 5 and 8 months post-baseline
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).
Measured at baseline and 5 and 8 months post-baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

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Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 avril 2018

Achèvement primaire (Réel)

31 juillet 2019

Achèvement de l'étude (Réel)

31 juillet 2019

Dates d'inscription aux études

Première soumission

8 février 2018

Première soumission répondant aux critères de contrôle qualité

14 février 2018

Première publication (Réel)

19 février 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 juin 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 mai 2020

Dernière vérification

1 mai 2020

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • R34MH111460 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur VIH

Essais cliniques sur Game Changers

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