Clinical trial NCT00710060: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Sexually Transmitted Diseases
Keywords: HIV
Popular Opinion Leader
POL
Behavioral Intervention
STD
STI
Community
Prevention
International
Global
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-07-03
Enrollment: 18147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

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