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

2013년 11월 1일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

18147

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • St. Petersburg, 러시아 연방, 197110
        • Biomedical Center
      • Chennai, 인도, 600 113
        • YRG Centre for AIDS Research and Education (YRGCARE)
      • Fuzhou, 중국, 350003
        • Fujian Institute of Health Education
      • Harare, 짐바브웨
        • Zimbabwe Community Health Intervention Research (ZiCHIRe) - University of Zimbabwe
      • Lima, 페루
        • Universidad Peruana Cayetano Heredia

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른 이름들:
  • Popular Opinion Leader (POL)
  • Diffusion of Innovations
Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.
활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Frequency of unprotected sexual acts with nonspousal partners
기간: 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
기간: Measured at baseline and Years 1 and 2
Measured at baseline and Years 1 and 2

2차 결과 측정

결과 측정
기간
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
기간: Measured at Year 2
Measured at Year 2

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2002년 9월 1일

기본 완료 (실제)

2007년 8월 1일

연구 완료 (실제)

2007년 8월 1일

연구 등록 날짜

최초 제출

2008년 6월 30일

QC 기준을 충족하는 최초 제출

2008년 6월 30일

처음 게시됨 (추정)

2008년 7월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 11월 1일

마지막으로 확인됨

2008년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • U10MH061537 (미국 NIH 보조금/계약)
  • DAHBR 9A-ASGT
  • U10MH061499 (미국 NIH 보조금/계약)
  • U10MH061513 (미국 NIH 보조금/계약)
  • U10MH061536 (미국 NIH 보조금/계약)
  • U10MH061543 (미국 NIH 보조금/계약)
  • U10MH061544 (미국 NIH 보조금/계약)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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