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Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations

1 novembre 2013 mis à jour par: RTI International

NIMH Collaborative HIV/STD Prevention Trial

This study will evaluate the effectiveness of a community-level HIV prevention program in promoting safer sexual behaviors and reducing the transmission of HIV/sexually transmitted diseases among at-risk populations in China, India, Peru, Russia, and Zimbabwe.

Aperçu de l'étude

Description détaillée

The HIV/AIDS epidemic remains largely out of control in many areas of the world, with an estimated 2.5 million new HIV infections worldwide in 2007. Developing countries with few economic resources and world regions undergoing difficult social transitions have been particularly impacted by large increases in HIV and sexually transmitted disease (STD) infections. To date, effective individual prevention approaches have not been rapid enough to avert the epidemic in these areas and may be too resource intensive to maintain. Behavioral HIV prevention interventions on the community level seek to reduce the prevalence of high-risk sexual behaviors by reaching large numbers of vulnerable people in a cost-effective and feasible manner, even in areas with limited resources. The Community Popular Opinion Leader (C-POL) program is an HIV prevention intervention that recruits and trains trusted opinion leaders in the community to promote safe sex behaviors through risk-reduction conversations with peers. Implementing the C-POL program in world regions facing significant HIV/AIDS epidemics may be the most effective means of encouraging behavior change among members of at-risk populations and strengthening social norms to maintain these changes. This study will evaluate the effectiveness of the C-POL program in promoting safer sexual behaviors and reducing the transmission of HIV/STDs among at-risk populations in China, India, Peru, Russia, and Zimbabwe.

Participation in this study will last 2 years. Initially, an ethnographic study will be conducted to determine the HIV/STD knowledge, attitudes, and behaviors among the population living in the target communities. Information collected via observation, focus groups, and interviews will be used to determine the social risk groups operating within the community and to identify and recruit the opinion leaders who are influential in these groups. Also, an epidemiological study will be conducted to collect information on sexual behaviors and HIV/STD rates.

A cohort of members from participating communities will first undergo baseline assessments that will include a survey about general health and knowledge of HIV/STDs and a biological sampling for HIV/STD testing. Participating communities will then be assigned randomly to receive the C-POL intervention and HIV/STD educational materials or HIV/STD educational materials alone. In communities receiving the C-POL intervention, the previously recruited opinion leaders will be taught skills for sharing HIV risk-reduction messages in daily conversation with peers. This training will occur over four to five weekly sessions. At least 15% of the community population will be trained as opinion leaders. After the initial training, opinion leaders will attend six to nine booster sessions over the next 2 years to reinforce and support continued conversation efforts. Communities assigned to receive the HIV/STD educational materials will receive informational materials on HIV/STDs to provide to community members and will provide treatment or treatment referral for people with nonviral STDs.

All participants in the baseline cohort will be asked to repeat the baseline testing 1 and 2 years later. Participants who are not able to visit a clinic for testing will be contacted by phone to complete the baseline survey. After the 2-year assessments, the C-POL intervention will be conducted in the communities that received educational materials only.

Type d'étude

Interventionnel

Inscription (Réel)

18147

Phase

  • Phase 3

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

      • Fuzhou, Chine, 350003
        • Fujian Institute of Health Education
      • St. Petersburg, Fédération Russe, 197110
        • Biomedical Center
      • Chennai, Inde, 600 113
        • YRG Centre for AIDS Research and Education (YRGCARE)
      • Lima, Pérou
        • Universidad Peruana Cayetano Heredia
      • Harare, Zimbabwe
        • Zimbabwe Community Health Intervention Research (ZiCHIRe) - University of Zimbabwe

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 à 49 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Either lives, works, or socializes in the selected venues
  • Plans to remain in the venue for at least 1 year after study entry

Exclusion Criteria:

  • Permanent disability that hinders participation (e.g. deaf, mental retardation)
  • Reports no sex in the 6 months before study entry (China, Peru)
  • No STDs present at study entry (China)
  • Enrolled in final year of school at time of recruitment (Russia)
  • Has lived in venue for less than 2 years (Zimbabwe)
  • Lives in venue for less than 9 months out of a year (Zimbabwe)

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: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 1
Participating communities will receive the Community Popular Opinion Leader intervention and HIV/STD educational materials.
The C-POL intervention will teach identified opinion leaders to share personalized HIV prevention messages in conversations with peers in an effort to change community norms. Opinion leaders will be taught skills for sharing HIV risk-reduction messages during four to five weekly training sessions. At least 15% of the community population will be trained as opinion leaders. After the initial training, opinion leaders will attend six to nine booster sessions over the next 2 years to reinforce and support continued conversation efforts.
Autres noms:
  • Popular Opinion Leader (POL)
  • Diffusion of Innovations
Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.
Comparateur actif: 2
Participating communities will receive HIV/STD educational materials only.
Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Frequency of unprotected sexual acts with nonspousal partners
Délai: Measured at baseline and Years 1 and 2
Measured at baseline and Years 1 and 2
Overall observed incidence of sexually transmitted diseases (STDs) (e.g., chlamydia, gonorrhea, syphilis, trichomonas, HIV, or herpes simplex virus-2), as detected by biological specimens
Délai: Measured at baseline and Years 1 and 2
Measured at baseline and Years 1 and 2

Mesures de résultats secondaires

Mesure des résultats
Délai
Increased exposure to HIV prevention messages, more STD treatment seeking, lower stigma regarding HIV and STDs, and lower substance abuse associated with sexual behavior in intervention group as compared to control group
Délai: Measured at Year 2
Measured at Year 2

Collaborateurs et enquêteurs

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

Parrainer

Les enquêteurs

  • Chercheur principal: Carlos F. Caceres, PhD, Cayetano Heredia University, Lima, Peru
  • Chercheur principal: David D. Celentano, ScD, The Johns Hopkins University, Baltimore, Maryland (India)
  • Chercheur principal: Thomas J. Coates, PhD, University of California at Los Angeles, Los Angeles, California (Peru)
  • Chercheur principal: Tyler D. Hartwell, PhD, RTI International, Research Triangle Park, North Carolina (DCC)
  • Chercheur principal: Danuta Kasprzyk, PhD, Battelle Center for Public Health Research and Evaluation, Seattle, Washington (Zimbabwe)
  • Chercheur principal: Jeffrey A. Kelly, PhD, Medical College of Wisconsin, Milwaukee, Wisconsin (Russia)
  • Chercheur principal: Andrei P. Kozlov, PhD, Biomedical Center, St. Petersburg State University, St. Petersburg, Russia
  • Chercheur principal: Willo Pequegnat, PhD, National Institute of Mental Health, Bethesda, Maryland
  • Chercheur principal: Mary Jane Rotheram-Borus, PhD, University of California at Los Angeles, Los Angeles, California (China)
  • Chercheur principal: Suniti Solomon, MD, YRG Centre for AIDS Research and Education, Chennai, India
  • Chercheur principal: Godfrey B. Woelk, PhD, University of Zimbabwe Medical School, Harare, Zimbabwe
  • Chercheur principal: Zunyou Wu, MD, PhD, Chinese Center for Disease Control and Prevention, Beijing, P.R. China

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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

1 septembre 2002

Achèvement primaire (Réel)

1 août 2007

Achèvement de l'étude (Réel)

1 août 2007

Dates d'inscription aux études

Première soumission

30 juin 2008

Première soumission répondant aux critères de contrôle qualité

30 juin 2008

Première publication (Estimation)

3 juillet 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

3 novembre 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 novembre 2013

Dernière vérification

1 juillet 2008

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • U10MH061537 (Subvention/contrat des NIH des États-Unis)
  • DAHBR 9A-ASGT
  • U10MH061499 (Subvention/contrat des NIH des États-Unis)
  • U10MH061513 (Subvention/contrat des NIH des États-Unis)
  • U10MH061536 (Subvention/contrat des NIH des États-Unis)
  • U10MH061543 (Subvention/contrat des NIH des États-Unis)
  • U10MH061544 (Subvention/contrat des NIH des États-Unis)

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 .

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