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

November 1, 2013 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18147

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of unprotected sexual acts with nonspousal partners
Time Frame: 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
Time Frame: Measured at baseline and Years 1 and 2
Measured at baseline and Years 1 and 2

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Measured at Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI International

Collaborators

National Institute of Mental Health (NIMH)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

June 30, 2008

First Submitted That Met QC Criteria

June 30, 2008

First Posted (Estimate)

July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

November 3, 2013

Last Update Submitted That Met QC Criteria

November 1, 2013

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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