Effectiveness of Community-Level Behavioral and Biomedical Interventions for Reducing HIV/STIs in Men in Peru
Condition: HIV Infections; Sexually Transmitted Infections
MeSH terms: Infections; Communicable Diseases; Sexually Transmitted Diseases
Study type: Interventional

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.
    

Intervention name(s): Enhanced Partner Therapy (EPT); Communidades Positivas (CPOS); Standard Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): EPT, a biomedical intervention, is designed to reduce the rate of sexually transmitted infection (STI) reinfection and, therefore, incident STIs. Men who have sex with men (MSM) with incident STIs will be given partner treatment packets that contain informational brochures, reference cards, prophylactic medications, and condoms for their sexual partners.; The behavioral intervention, CPOS, is based on a combination of social-action theory and diffusion of innovation and is designed to reduce the frequency of unprotected sex with nonprimary partners. 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 partners. CPOS will include a training program of at least 14 sessions. During these sessions, MSM leaders will be provided with information about HIV/STIs and their prevention and ways to strengthen leadership skills. The 2-hour group sessions will occur two times a week for 7 weeks. While the training sessions are underway, MSM leaders will be asked to work with community leaders to form a community center from which they will carry out HIV/STI prevention and promotion of sexual health activities for 18 months.; Standard care will consist of usual care for STIs.
Other intervention name(s): EPT; CPOS
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Men Who Have Sex With Men