Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 7:58 AM
Study NCT ID:
NCT00710060
Status:
COMPLETED
Last Update Posted:
2013-11-04
First Post:
2008-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-01', 'studyFirstSubmitDate': '2008-06-30', 'studyFirstSubmitQcDate': '2008-06-30', 'lastUpdatePostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of unprotected sexual acts with nonspousal partners', 'timeFrame': 'Measured at baseline and Years 1 and 2'}, {'measure': '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', 'timeFrame': 'Measured at baseline and Years 1 and 2'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'Measured at Year 2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Popular Opinion Leader', 'POL', 'Behavioral Intervention', 'STD', 'STI', 'Community', 'Prevention', 'International', 'Global'], 'conditions': ['HIV Infections', 'Sexually Transmitted Diseases']}, 'referencesModule': {'references': [{'pmid': '17413262', 'type': 'BACKGROUND', 'citation': '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': '17413260', 'type': 'BACKGROUND', 'citation': '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': '17413261', 'type': 'BACKGROUND', 'citation': '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': '17413263', 'type': 'BACKGROUND', 'citation': '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': '17413264', 'type': 'BACKGROUND', 'citation': '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': '17413265', 'type': 'BACKGROUND', 'citation': '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': '17413266', 'type': 'BACKGROUND', 'citation': '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': '17413267', 'type': 'BACKGROUND', 'citation': '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': '17413268', 'type': 'BACKGROUND', 'citation': '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': '17413269', 'type': 'BACKGROUND', 'citation': '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': '21278400', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.rti.org/u10', 'label': 'Click here for more information on this study at the NIMH Collaborative HIV/STD Prevention Trial Web site'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nParticipation 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.\n\nA 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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either lives, works, or socializes in the selected venues\n* Plans to remain in the venue for at least 1 year after study entry\n\nExclusion Criteria:\n\n* Permanent disability that hinders participation (e.g. deaf, mental retardation)\n* Reports no sex in the 6 months before study entry (China, Peru)\n* No STDs present at study entry (China)\n* Enrolled in final year of school at time of recruitment (Russia)\n* Has lived in venue for less than 2 years (Zimbabwe)\n* Lives in venue for less than 9 months out of a year (Zimbabwe)'}, 'identificationModule': {'nctId': 'NCT00710060', 'briefTitle': 'Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations', 'organization': {'class': 'OTHER', 'fullName': 'RTI International'}, 'officialTitle': 'NIMH Collaborative HIV/STD Prevention Trial', 'orgStudyIdInfo': {'id': 'U10MH061537', 'link': 'https://reporter.nih.gov/quickSearch/U10MH061537', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U10MH061537', 'link': 'https://reporter.nih.gov/quickSearch/U10MH061537', 'type': 'NIH'}, {'id': 'U10MH061499', 'link': 'https://reporter.nih.gov/quickSearch/U10MH061499', 'type': 'NIH'}, {'id': 'U10MH061513', 'link': 'https://reporter.nih.gov/quickSearch/U10MH061513', 'type': 'NIH'}, {'id': 'U10MH061536', 'link': 'https://reporter.nih.gov/quickSearch/U10MH061536', 'type': 'NIH'}, {'id': 'U10MH061543', 'link': 'https://reporter.nih.gov/quickSearch/U10MH061543', 'type': 'NIH'}, {'id': 'U10MH061544', 'link': 'https://reporter.nih.gov/quickSearch/U10MH061544', 'type': 'NIH'}, {'id': 'DAHBR 9A-ASGT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participating communities will receive the Community Popular Opinion Leader intervention and HIV/STD educational materials.', 'interventionNames': ['Behavioral: Community Popular Opinion Leader (C-POL)', 'Behavioral: HIV/STD educational materials']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participating communities will receive HIV/STD educational materials only.', 'interventionNames': ['Behavioral: HIV/STD educational materials']}], 'interventions': [{'name': 'Community Popular Opinion Leader (C-POL)', 'type': 'BEHAVIORAL', 'otherNames': ['Popular Opinion Leader (POL)', 'Diffusion of Innovations'], '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.', 'armGroupLabels': ['1']}, {'name': 'HIV/STD educational materials', 'type': 'BEHAVIORAL', 'description': 'Communities will receive HIV/STD educational materials and treatment referral information to distribute to community members.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350003', 'city': 'Fuzhou', 'country': 'China', 'facility': 'Fujian Institute of Health Education', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '600 113', 'city': 'Chennai', 'country': 'India', 'facility': 'YRG Centre for AIDS Research and Education (YRGCARE)', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Universidad Peruana Cayetano Heredia', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '197110', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Biomedical Center', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'Zimbabwe Community Health Intervention Research (ZiCHIRe) - University of Zimbabwe', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Carlos F. Caceres, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cayetano Heredia University, Lima, Peru'}, {'name': 'David D. Celentano, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Johns Hopkins University, Baltimore, Maryland (India)'}, {'name': 'Thomas J. Coates, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California at Los Angeles, Los Angeles, California (Peru)'}, {'name': 'Tyler D. Hartwell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RTI International, Research Triangle Park, North Carolina (DCC)'}, {'name': 'Danuta Kasprzyk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Battelle Center for Public Health Research and Evaluation, Seattle, Washington (Zimbabwe)'}, {'name': 'Jeffrey A. Kelly, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin (Russia)'}, {'name': 'Andrei P. Kozlov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biomedical Center, St. Petersburg State University, St. Petersburg, Russia'}, {'name': 'Willo Pequegnat, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Mental Health, Bethesda, Maryland'}, {'name': 'Mary Jane Rotheram-Borus, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California at Los Angeles, Los Angeles, California (China)'}, {'name': 'Suniti Solomon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'YRG Centre for AIDS Research and Education, Chennai, India'}, {'name': 'Godfrey B. Woelk, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zimbabwe Medical School, Harare, Zimbabwe'}, {'name': 'Zunyou Wu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, P.R. China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RTI International', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Willo Pequegnat, PhD/Principal Investigator', 'oldOrganization': 'National Institute of Mental Health (NIMH)'}}}}