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

NCT00670163 | Completed DMC

• 2 other identifiers: R01MH078752DAHBR 9A-ASGP
• Study Type: interventional
• Target: 718
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Sexually Transmitted Infections

Keywords

Men Who Have Sex With Men

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of STIs

  Measured at Month 18

Secondary Outcomes (1)

• Rates of unprotected intercourse with nonprimary partners

  Measured at Month 18

Study Arms (4)

1

EXPERIMENTAL

Participating community will provide Comunidades Positivas plus enhanced partner therapy.

Behavioral: Enhanced Partner Therapy (EPT); Behavioral: Communidades Positivas (CPOS)

2

EXPERIMENTAL

Participating community will provide enhanced partner therapy alone.

Behavioral: Enhanced Partner Therapy (EPT)

3

EXPERIMENTAL

Participating community will provide Comunidades Positivas alone.

Behavioral: Communidades Positivas (CPOS)

4

ACTIVE COMPARATOR

Participating community will provide standard of care.

Behavioral: Standard Care

Interventions

Enhanced Partner Therapy (EPT) BEHAVIORAL

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.

Also known as: EPT

1; 2

Communidades Positivas (CPOS) BEHAVIORAL

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.

Also known as: CPOS

1; 3

Standard Care BEHAVIORAL

Standard care will consist of usual care for STIs.

4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• For all participants:
• Imminent plans to move away from the study barrio for the duration of the study

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Universidad Peruana Cayetano Heredia

Lima, Lima Province, 18, Peru

Location

Related Publications (1)

• 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.

  PMID: 26739719 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases; Homosexuality

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Thomas J. Coates, PhD

  The University of California, Los Angeles (UCLA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

PE (1)