Clinical trial NCT00670163: Effectiveness of Community-Level Behavioral and Biomedical Interventions for Reducing HIV/STIs in Men in Peru
Official title: Comunidades Positivas and Enhanced Partner Therapy in Peru
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Infections
Keywords: Men Who Have Sex With Men
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-05-01
Enrollment: 718
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of STIs
timeFrame: Measured at Month 18
Secondary outcomes:
measure: Rates of unprotected intercourse with nonprimary partners
timeFrame: Measured at Month 18
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Universidad Peruana Cayetano Heredia
Study officials:
affiliation: The University of California, Los Angeles (UCLA)
name: Thomas J. Coates, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leon SR, Segura ER, Konda KA, Flores JA, Silva-Santisteban A, Galea JT, Coates TJ, Klausner JD, Caceres CF. High prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae infections in anal and pharyngeal sites among a community-based sample of men who have sex with men and transgender women in Lima, Peru. BMJ Open. 2016 Jan 6;6(1):e008245. doi: 10.1136/bmjopen-2015-008245.