Effectiveness of Community-Level Behavioral and Biomedical Interventions for Reducing HIV/STIs in Men in Peru

Not Applicable

Completed

• Conditions: Sexually Transmitted Infections; HIV Infections
• Interventions: Behavioral: Enhanced Partner Therapy (EPT); Behavioral: Standard Care; Behavioral: Communidades Positivas (CPOS)

• Registration Number: NCT00670163
• Lead Sponsor: University of California, Los Angeles

Brief Summary

This study will evaluate the effectiveness of community-level behavioral and biomedical interventions, each alone and combined, in reducing sexual risk behavior and HIV/sexually transmitted infections in Peruvian men who have sex with men.

Detailed Description

Sexually transmitted infections (STIs), including HIV, are among the most significant public health concerns worldwide. Although common across all groups of people, STIs have had a considerable impact among men who have sex with men (MSM). Particularly, in Peru, which accounts for about 6% of the estimated HIV infections in Latin America, HIV and STIs are highly concentrated in the MSM population.

Both behavioral and biomedical interventions are needed to provide education about the health risks associated with unprotected sex and to help those with STIs seek treatment. Communidades Positivas (CPOS) (Spanish for "Positive Communities") is a behavioral intervention designed to reduce the frequency of sexual activity with nonprimary partners. Enhanced partner therapy (EPT) is a biomedical intervention designed to provide treatment to partners who may become or already are infected with an STI and to thereby reduce the rate of reinfections. When implemented individually or together at a community level, these interventions may be effective in preventing HIV/STI transmission in MSM. This study will evaluate the effectiveness of community-level CPOS and EPT, each alone and combined, in reducing sexual risk behavior and HIV/STIs in Peruvian MSM.

Participation in this study will last 18 months. A total of 24 communities will be assigned randomly to 1 of 4 different treatment groups:

* Communities in Group 1 will provide CPOS plus EPT to MSM.

* Communities in Group 2 will provide CPOS alone to MSM.

* Communities in Group 3 will provide EPT alone to MSM.

* Communities in Group 4 will provide standard care to MSM.

Within each community, a select number of MSM will be evaluated at various points during the study. The initial evaluation visit will occur prior to any treatment and will include an interview, counseling, and HIV/STI testing. The interview will involve questions about health and community, including topics such as sexual activities, views on health problems, use of alcohol and drugs, use of health care services, and attitudes about people with HIV or AIDS. Counselors will then provide information about contracting and preventing HIV/STIs and will ask questions about STI symptoms. Finally, HIV/STI testing will be conducted and throat and anal swabs will be collected. Two weeks after the initial evaluation, MSM will receive their test results, and if positive for HIV or any STIs, they will receive appropriate referrals, services, and treatments. They will also receive the specific treatment to which their community was assigned and will be asked additional questions concerning the treatment of their partners, if applicable. The remaining evaluations, which will repeat assessments from the initial evaluation, will occur at months 9 and 18.

Standard care will include the care that has been established by the Peruvian national guidelines for managing HIV and STIs. In EPT, MSM will be encouraged to pass along to their recent partners packets that contain informational brochures, reference cards, prophylactic medications, and condoms. In CPOS, MSM who are recognized by their peers as leaders will be trained to implement a community center that provides information, support, and empowerment to MSM, their friends, and their partners.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-04-29
• Study First Posted: 2008-05-01
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 718

Inclusion Criteria

For MSM evaluation group:

• Anatomically male at birth (by self-report)
• Lives in study barrio OR works in study barrio OR socializes in study barrio (present at least 3 times per week)
• Anal or oral sexual intercourse with another male in the 12 months before study entry
• Stated preference for sexual relations with males

For CPOS group:

• Self-identifies as a man who has sex with men

Exclusion Criteria

For all participants:

• Imminent plans to move away from the study barrio for the duration of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Communidades Positivas (CPOS)	Participating community will provide Comunidades Positivas plus enhanced partner therapy.
2	Enhanced Partner Therapy (EPT)	Participating community will provide enhanced partner therapy alone.
3	Communidades Positivas (CPOS)	Participating community will provide Comunidades Positivas alone.
1	Enhanced Partner Therapy (EPT)	Participating community will provide Comunidades Positivas plus enhanced partner therapy.
4	Standard Care	Participating community will provide standard of care.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of STIs	Measured at Month 18

Secondary Outcome Measures

Name	Time	Method
Rates of unprotected intercourse with nonprimary partners	Measured at Month 18

Trial Locations

Locations (1)

Universidad Peruana Cayetano Heredia; 🇵🇪 Lima, Peru