HIV Infections Clinical Trial
Official title:
Comunidades Positivas and Enhanced Partner Therapy in Peru
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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