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

HIV Infections Clinical Trial

Official title:

NIMH Collaborative HIV/STD Prevention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710060
• Other study ID #: U10MH061537
• Secondary ID: U10MH061537U10MH
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2008
• Last updated: November 1, 2013
• Start date: September 2002
• Est. completion date: August 2007

Study information

• Verified date: July 2008
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentChina: Ethics CommitteeChina: Ministry of HealthIndia: Institutional Review BoardPeru: Ethics CommitteeRussia: Ethics CommitteeZimbabwe: Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18147
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Diseases

Intervention

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

Locations

Country	Name	City	State
China	Fujian Institute of Health Education	Fuzhou
India	YRG Centre for AIDS Research and Education (YRGCARE)	Chennai
Peru	Universidad Peruana Cayetano Heredia	Lima
Russian Federation	Biomedical Center	St. Petersburg
Zimbabwe	Zimbabwe Community Health Intervention Research (ZiCHIRe) - University of Zimbabwe	Harare

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

China,  India,  Peru,  Russian Federation,  Zimbabwe, 

References & Publications (10)

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. — View 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:S37-48. — View Citation

NIMH Collaborative HIV/STD Prevention Trial Group. Ethical issues in the NIMH Collaborative HIV/STD Prevention Trial. AIDS. 2007 Apr;21 Suppl 2:S69-80. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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:S49-58. — View 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:S99-102. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of unprotected sexual acts with nonspousal partners		Measured at baseline and Years 1 and 2	No
Primary	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	No
Secondary	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	No

External Links

•   Click here for more information on this study at the NIMH Collaborative HIV/STD Prevention Trial Web site