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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
RTI International
ClinicalTrials.gov Identifier:
NCT00710060
First received: June 30, 2008
Last updated: November 1, 2013
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
HIV Infections
Sexually Transmitted Diseases
Behavioral: Community Popular Opinion Leader (C-POL)
Behavioral: HIV/STD educational materials
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: NIMH Collaborative HIV/STD Prevention Trial

Resource links provided by NLM:


Further study details as provided by RTI International:

Primary Outcome Measures:
  • Frequency of unprotected sexual acts with nonspousal partners [ Time Frame: Measured at baseline and Years 1 and 2 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Measured at baseline and Years 1 and 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]

Enrollment: 18147
Study Start Date: September 2002
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participating communities will receive the Community Popular Opinion Leader intervention and HIV/STD educational materials.
Behavioral: Community Popular Opinion Leader (C-POL)
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.
Other Names:
  • Popular Opinion Leader (POL)
  • Diffusion of Innovations
Behavioral: HIV/STD educational materials
Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.
Active Comparator: 2
Participating communities will receive HIV/STD educational materials only.
Behavioral: HIV/STD educational materials
Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710060

Locations
China
Fujian Institute of Health Education
Fuzhou, China, 350003
India
YRG Centre for AIDS Research and Education (YRGCARE)
Chennai, India, 600 113
Peru
Universidad Peruana Cayetano Heredia
Lima, Peru
Russian Federation
Biomedical Center
St. Petersburg, Russian Federation, 197110
Zimbabwe
Zimbabwe Community Health Intervention Research (ZiCHIRe) - University of Zimbabwe
Harare, Zimbabwe
Sponsors and Collaborators
RTI International
Investigators
Principal Investigator: Carlos F. Caceres, PhD Cayetano Heredia University, Lima, Peru
Principal Investigator: David D. Celentano, ScD The Johns Hopkins University, Baltimore, Maryland (India)
Principal Investigator: Thomas J. Coates, PhD University of California at Los Angeles, Los Angeles, California (Peru)
Principal Investigator: Tyler D. Hartwell, PhD RTI International, Research Triangle Park, North Carolina (DCC)
Principal Investigator: Danuta Kasprzyk, PhD Battelle Center for Public Health Research and Evaluation, Seattle, Washington (Zimbabwe)
Principal Investigator: Jeffrey A. Kelly, PhD Medical College of Wisconsin, Milwaukee, Wisconsin (Russia)
Principal Investigator: Andrei P. Kozlov, PhD Biomedical Center, St. Petersburg State University, St. Petersburg, Russia
Principal Investigator: Willo Pequegnat, PhD National Institute of Mental Health, Bethesda, Maryland
Principal Investigator: Mary Jane Rotheram-Borus, PhD University of California at Los Angeles, Los Angeles, California (China)
Principal Investigator: Suniti Solomon, MD YRG Centre for AIDS Research and Education, Chennai, India
Principal Investigator: Godfrey B. Woelk, PhD University of Zimbabwe Medical School, Harare, Zimbabwe
Principal Investigator: Zunyou Wu, MD, PhD Chinese Center for Disease Control and Prevention, Beijing, P.R. China
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Willo Pequegnat, PhD/Principal Investigator, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00710060     History of Changes
Other Study ID Numbers: U10 MH61537, U10MH061537, U10MH061499, U10MH061513, U10MH061536, U10MH061543, U10MH061544, DAHBR 9A-ASGT
Study First Received: June 30, 2008
Last Updated: November 1, 2013
Health Authority: United States: Federal Government
China: Ethics Committee
China: Ministry of Health
India: Institutional Review Board
Peru: Ethics Committee
Russia: Ethics Committee
Zimbabwe: Medical Research Council

Keywords provided by RTI International:
HIV
Popular Opinion Leader
POL
Behavioral Intervention
STD
STI
Community
Prevention
International
Global

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 20, 2014