NCT00710060

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,147

participants targeted

Target at P75+ for phase_3 hiv-infections

Timeline
Completed

Started Sep 2002

Typical duration for phase_3 hiv-infections

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
Last Updated

November 4, 2013

Status Verified

July 1, 2008

Enrollment Period

4.9 years

First QC Date

June 30, 2008

Last Update Submit

November 1, 2013

Conditions

HIV InfectionsSexually Transmitted Diseases

Keywords

HIVPopular Opinion LeaderPOLBehavioral InterventionSTDSTICommunityPreventionInternationalGlobal

Outcome Measures

Primary Outcomes (2)

  • Frequency of unprotected sexual acts with nonspousal partners

    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

    Measured at baseline and Years 1 and 2

Secondary Outcomes (1)

  • 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

    Measured at Year 2

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Community Popular Opinion Leader (C-POL)Behavioral: HIV/STD educational materials

2

ACTIVE COMPARATOR

Participating communities will receive HIV/STD educational materials only.

Behavioral: HIV/STD educational materials

Interventions

Community Popular Opinion Leader (C-POL)BEHAVIORAL

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.

Also known as: Popular Opinion Leader (POL), Diffusion of Innovations
1
HIV/STD educational materialsBEHAVIORAL

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

12

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Either lives, works, or socializes in the selected venues
  • Plans to remain in the venue for at least 1 year after study entry

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fujian Institute of Health Education

Fuzhou, 350003, China

Location

YRG Centre for AIDS Research and Education (YRGCARE)

Chennai, 600 113, India

Location

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Biomedical Center

Saint Petersburg, 197110, Russia

Location

Zimbabwe Community Health Intervention Research (ZiCHIRe) - University of Zimbabwe

Harare, Zimbabwe

Location

Related Publications (11)

  • NIMH Collaborative HIV/STD Prevention Trial Group. Methodological overview of a five-country community-level HIV/sexually transmitted disease prevention trial. AIDS. 2007 Apr;21 Suppl 2:S3-18. doi: 10.1097/01.aids.0000266453.18644.27.

    PMID: 17413262BACKGROUND

  • NIMH Collaborative HIV/STD Prevention Trial Group. Selection of populations represented in the NIMH Collaborative HIV/STD Prevention Trial. AIDS. 2007 Apr;21 Suppl 2:S19-28. doi: 10.1097/01.aids.0000266454.26268.90.

    PMID: 17413260BACKGROUND

  • NIMH Collaborative HIV/STD Prevention Trial Group. Challenges and processes of selecting outcome measures for the NIMH Collaborative HIV/STD Prevention Trial. AIDS. 2007 Apr;21 Suppl 2:S29-36. doi: 10.1097/01.aids.0000266455.03397.08.

    PMID: 17413261BACKGROUND

  • NIMH Collaborative HIV/STD Prevention Trial Group. Design and integration of ethnography within an international behavior change HIV/sexually transmitted disease prevention trial. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S37-48. doi: 10.1097/01.aids.0000266456.03397.d3.

    PMID: 17413263BACKGROUND

  • NIMH Collaborative HIV/STD Prevention Trial Group. The feasibility of audio computer-assisted self-interviewing in international settings. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S49-58. doi: 10.1097/01.aids.0000266457.11020.f0.

    PMID: 17413264BACKGROUND

  • NIMH Collaborative HIV/STD Prevention Trial Group. The community popular opinion leader HIV prevention programme: conceptual basis and intervention procedures. AIDS. 2007 Apr;21 Suppl 2:S59-68. doi: 10.1097/01.aids.0000266458.49138.fa.

    PMID: 17413265BACKGROUND

  • NIMH Collaborative HIV/STD Prevention Trial Group. Ethical issues in the NIMH Collaborative HIV/STD Prevention Trial. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S69-80. doi: 10.1097/01.aids.0000266459.49138.b3.

    PMID: 17413266BACKGROUND

  • NIMH Collaborative HIV/STD Prevention Trial Group. Sexually transmitted disease and HIV prevalence and risk factors in concentrated and generalized HIV epidemic settings. AIDS. 2007 Apr;21 Suppl 2:S81-90. doi: 10.1097/01.aids.0000266460.56762.84.

    PMID: 17413267BACKGROUND

  • NIMH Collaborative HIV/STD Prevention Trial Group. Formative study conducted in five countries to adapt the community popular opinion leader intervention. AIDS. 2007 Apr;21 Suppl 2:S91-8. doi: 10.1097/01.aids.0000266461.33891.d0.

    PMID: 17413268BACKGROUND

  • NIMH Collaborative HIV/STD Prevention Trial. Role of the data safety and monitoring board in an international trial. AIDS. 2007 Apr;21 Suppl 2(Suppl 2):S99-102. doi: 10.1097/01.aids.0000266462.33891.0b.

    PMID: 17413269BACKGROUND

  • Rotheram-Borus MJ, Wu Z, Liang LJ, Li L, Detels R, Guan J, Yin Y, Swendeman D; NIMH Collaborative HIV/STD Prevention Trial Group. Reductions in sexually transmitted infections associated with popular opinion leaders in China in a randomised controlled trial. Sex Transm Infect. 2011 Jun;87(4):337-43. doi: 10.1136/sti.2010.046243. Epub 2011 Jan 29.

    PMID: 21278400DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2008

First Posted

July 3, 2008

Study Start

September 1, 2002

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

November 4, 2013

Record last verified: 2008-07

Locations

CN(1)ZI(1)PE(1)RU(1)IN(1)