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

Primary Purpose

HIV Infections, Sexually Transmitted Infections

Status
Completed
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Enhanced Partner Therapy (EPT)
Communidades Positivas (CPOS)
Standard Care
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Men Who Have Sex With Men

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad Peruana Cayetano Heredia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

4

Arm Description

Participating community will provide Comunidades Positivas plus enhanced partner therapy.

Participating community will provide enhanced partner therapy alone.

Participating community will provide Comunidades Positivas alone.

Participating community will provide standard of care.

Outcomes

Primary Outcome Measures

Cumulative incidence of STIs

Secondary Outcome Measures

Rates of unprotected intercourse with nonprimary partners

Full Information

First Posted
April 29, 2008
Last Updated
December 11, 2013
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00670163
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Infections
Keywords
Men Who Have Sex With Men

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
718 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participating community will provide Comunidades Positivas plus enhanced partner therapy.
Arm Title
2
Arm Type
Experimental
Arm Description
Participating community will provide enhanced partner therapy alone.
Arm Title
3
Arm Type
Experimental
Arm Description
Participating community will provide Comunidades Positivas alone.
Arm Title
4
Arm Type
Active Comparator
Arm Description
Participating community will provide standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Partner Therapy (EPT)
Other Intervention Name(s)
EPT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Communidades Positivas (CPOS)
Other Intervention Name(s)
CPOS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Standard care will consist of usual care for STIs.
Primary Outcome Measure Information:
Title
Cumulative incidence of STIs
Time Frame
Measured at Month 18
Secondary Outcome Measure Information:
Title
Rates of unprotected intercourse with nonprimary partners
Time Frame
Measured at Month 18

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J. Coates, PhD
Organizational Affiliation
The University of California, Los Angeles (UCLA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Peruana Cayetano Heredia
City
Lima
ZIP/Postal Code
18
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
26739719
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.
Results Reference
derived

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

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