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

1 november 2013 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

18147

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Chennai, Indien, 600 113
        • YRG Centre for AIDS Research and Education (YRGCARE)
      • Fuzhou, Kina, 350003
        • Fujian Institute of Health Education
      • Lima, Peru
        • Universidad Peruana Cayetano Heredia
      • St. Petersburg, Ryska Federationen, 197110
        • Biomedical Center
      • Harare, Zimbabwe
        • Zimbabwe Community Health Intervention Research (ZiCHIRe) - University of Zimbabwe

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 49 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Andra namn:
  • Popular Opinion Leader (POL)
  • Diffusion of Innovations
Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.
Aktiv komparator: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Frequency of unprotected sexual acts with nonspousal partners
Tidsram: 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
Tidsram: Measured at baseline and Years 1 and 2
Measured at baseline and Years 1 and 2

Sekundära resultatmått

Resultatmått
Tidsram
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
Tidsram: Measured at Year 2
Measured at Year 2

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2002

Primärt slutförande (Faktisk)

1 augusti 2007

Avslutad studie (Faktisk)

1 augusti 2007

Studieregistreringsdatum

Först inskickad

30 juni 2008

Först inskickad som uppfyllde QC-kriterierna

30 juni 2008

Första postat (Uppskatta)

3 juli 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

3 november 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 november 2013

Senast verifierad

1 juli 2008

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • U10MH061537 (U.S.S. NIH-anslag/kontrakt)
  • DAHBR 9A-ASGT
  • U10MH061499 (U.S.S. NIH-anslag/kontrakt)
  • U10MH061513 (U.S.S. NIH-anslag/kontrakt)
  • U10MH061536 (U.S.S. NIH-anslag/kontrakt)
  • U10MH061543 (U.S.S. NIH-anslag/kontrakt)
  • U10MH061544 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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