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

Primary Purpose

HIV Infections, Sexually Transmitted Diseases

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Community Popular Opinion Leader (C-POL)

HIV/STD educational materials

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, Popular Opinion Leader, POL, Behavioral Intervention, STD, STI, Community, Prevention, International, Global

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Fujian Institute of Health Education
YRG Centre for AIDS Research and Education (YRGCARE)
Universidad Peruana Cayetano Heredia
Biomedical Center
Zimbabwe Community Health Intervention Research (ZiCHIRe) - University of Zimbabwe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Participating communities will receive the Community Popular Opinion Leader intervention and HIV/STD educational materials.

Participating communities will receive HIV/STD educational materials only.

Outcomes

Primary Outcome Measures

Frequency of unprotected sexual acts with nonspousal partners

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

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

Full Information

NCT ID

NCT00710060

First Posted

June 30, 2008

Last Updated

November 1, 2013

Sponsor

RTI International

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00710060

Brief Title

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

Official Title

NIMH Collaborative HIV/STD Prevention Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

September 2002 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

RTI International

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Sexually Transmitted Diseases

Keywords

HIV, Popular Opinion Leader, POL, Behavioral Intervention, STD, STI, Community, Prevention, International, Global

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

18147 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Participating communities will receive the Community Popular Opinion Leader intervention and HIV/STD educational materials.

Arm Title

Arm Type

Active Comparator

Arm Description

Participating communities will receive HIV/STD educational materials only.

Intervention Type

Behavioral

Intervention Name(s)

Community Popular Opinion Leader (C-POL)

Other Intervention Name(s)

Popular Opinion Leader (POL), Diffusion of Innovations

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

HIV/STD educational materials

Intervention Description

Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.

Primary Outcome Measure Information:

Title

Frequency of unprotected sexual acts with nonspousal partners

Time Frame

Measured at baseline and Years 1 and 2

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

Measured at Year 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials: