Partner Notification Strategies for MSM in Peru

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of California, Los Angeles
Sponsor:
Collaborators:
Asociación Civil Impacta Salud y Educación, Peru
Information provided by (Responsible Party):
Jesse Clark, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01720641
First received: October 29, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

The goal of the proposed research is to assess new strategies for partner management and sexually transmitted infection (STI) control to reduce the spread of HIV-1 among men who have sex with men (MSM) in Latin America. The HIV epidemic in Peru remains concentrated within the core risk group of MSM. STI infection and re-infection are central to the continuation of the HIV epidemic among MSM in Peru. Development of improved strategies for partner notification and treatment will reduce the incidence and prevalence of STIs and ultimately reduce the incidence of HIV infection in this population. The first phase of this study used qualitative methods to explore attitudes and practices related to partner notification among MSM in Lima, Peru. Findings from the qualitative research were used to develop a quantitative survey instrument to assess partner notification decision-making processes and practices among MSM in Peru recently diagnosed with HIV or syphilis infection. Data from both quantitative and qualitative phases of the study have been used to develop a partner notification for MSM in Peru. Investigators plan to implement and assess the impact of the intervention on rates of partner notification following a diagnosis of syphilis among MSM in Lima, Peru. The investigators hypothesize that participants randomized to receive one or more partner notification tools will report a higher frequency of partner notification.


Condition Intervention
Partner Notification Following STI Diagnosis
Behavioral: Internet
Behavioral: Referral Card
Behavioral: Internet and Referral Card

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Partner Notification Strategies for STI Control in Urban Peru

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Self-Reported Partner Notification [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    Participant self-report of recent partner notification at 14-21 days of follow-up.


Secondary Outcome Measures:
  • Investigator-confirmed Partner Notification [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
    Participants who report notifying one or more of their three most recent partners will be asked for permission for the investigators to contact one or more of these partners to confirm notification outcomes. Partners who are successfully contacted and confirm prior partner notification will be defined as confirmed notifications.


Estimated Enrollment: 400
Study Start Date: August 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Standardized partner notification counseling
Experimental: Internet Notification
Standardized partner notification counseling and referral to internet-based partner referral website.
Behavioral: Internet
Referral and user instructions for Peru section of www.inspot.org partner notification website
Experimental: Referral Card
Standardized partner notification counseling and provision of 5 printed partner referral cards.
Behavioral: Referral Card
5 printed referral cards with information on syphilis signs, symptoms, diagnosis, treatment, and local resources.
Experimental: Internet and Referral Card
Standardized partner notification counseling and referral to internet-based partner referral website and provision of 5 printed partner referral cards.
Behavioral: Internet and Referral Card
5 printed referral cards with information on syphilis signs, symptoms, diagnosis, treatment, and local resources; Referral and user instructions for Peru section of www.inspot.org partner notification website.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Male or biologically male at birth
  3. Sexual contact (oral or anal intercourse) with a male or male-to-female transgender partner in the past 12 months
  4. Diagnosis with syphilis infection

Exclusion Criteria:

  1. Under 18 years of age
  2. Unable to understand informed consent procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720641

Contacts
Contact: Jesse L Clark, MD, MSc 310-601-7798 jlclark@mednet.ucla.edu
Contact: Eddy R Segura, MD, MPH 3106017798 eddysegura@gmail.com

Locations
Peru
Asociacion Civil Impacta Salud y Educacion Recruiting
Lima, Peru
Contact: Jesica Rios    562 1600      
Principal Investigator: Javier R Lama, MD, MPH         
Sponsors and Collaborators
University of California, Los Angeles
Asociación Civil Impacta Salud y Educación, Peru
Investigators
Principal Investigator: Jesse L Clark, MD, MSc University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Jesse Clark, Assistant Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01720641     History of Changes
Other Study ID Numbers: K23MH084611, IMP-478-2012, K23MH084611
Study First Received: October 29, 2012
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
MSM
Transgender Women
Partner Notification
Syphilis
Peru

ClinicalTrials.gov processed this record on July 23, 2014