Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men )(MSM) in Two Vietnamese Cities

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Development and Research Institutes, Inc.
Sponsor:
Collaborators:
Hanoi Medical University
University of Puerto Rico
Information provided by (Responsible Party):
National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier:
NCT02122094
First received: April 17, 2014
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

This study seeks to implement a sexual health promotion intervention for male sex workers in Hanoi and Ho Chi Minh City, Vietnam. The study hypothesis is that this intervention will increase testing, treatment and vaccination for sexually transmitted infections, including intentions of participants to engage in these services beyond the conclusion of the intervention. At the community level, the study hypothesis is that male sex workers will be more aware of sexual health care and more likely to access these services in the future.


Condition Intervention
HIV
Chlamydia
Gonorrhea
Syphilis
HCV
Behavioral: Sexual Health Promotion Intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implementation of a Sexual Health Intervention for YMSM in Two Vietnamese Cities

Resource links provided by NLM:


Further study details as provided by National Development and Research Institutes, Inc.:

Primary Outcome Measures:
  • Acceptance of testing [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Participants in the clinic-based Sexual Health Promotion intervention will accept offer of testing for chlamydia, gonorrhea, syphilis, HIV, HBV and Hepatitis C Virus.

  • Return for test results [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    Participants in the clinic-based Sexual Health Promotion intervention will return for their test results

  • Intention to access health services [ Time Frame: two years ] [ Designated as safety issue: No ]
    Participants who receive the community-based Sexual Health Promotion intervention will report intent to access health services for Sexually Transmitted Infection testing, treatment and vaccination


Estimated Enrollment: 1500
Study Start Date: May 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sexual Health Promotion Intervention
The SHP Intervention consists of seven core and five optional modules covering topics related to sexual health. It is delivered in both community (outreach) settings and i clinic-based settings.
Behavioral: Sexual Health Promotion Intervention
The seven core modules are 1) the Importance of Sexual Health, 2) Sexual Diversity, 3) HIV and other STIs, 4) Behavioral Risk and Risk Reduction, 5) Alcohol and Drugs, 6) Stigma and 7) Health Seeking Practices. The five optional modules are 1) HIV Treatment and Adherence, 2) Stress Reduction, 3) HIV Status Disclosure, 4) MSM/Gay Disclosure, and 5) Other Sexual Health Concerns

  Eligibility

Ages Eligible for Study:   16 Years to 29 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Born biologically male; age 16-29; exchanged sex for money or other material goods with another man in the past 90 days

Exclusion Criteria:

  • inability to provide informed consent
  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: NCT02122094

Contacts
Contact: Lloyd A Goldsamt, Ph.D. 212-845-4468 Goldsamt@ndri.org

Locations
Vietnam
Hanoi Medical University Recruiting
Hanoi, Vietnam
Contact: Le M Giang, MD, Ph.D.    +844 35 74 15 96    leminhgiang@hmu.edu.vn   
Principal Investigator: Le M Giang, MD, Ph.D.         
Center for Applied Research on Men and Health (CARMAH) Recruiting
Ho Chi Minh City, Vietnam
Contact: Bao Le, MSW    +848 094 488 4999    baolecarmah@gmail.com   
Principal Investigator: Le M Giang, MD, Ph.D.         
Sponsors and Collaborators
National Development and Research Institutes, Inc.
Hanoi Medical University
University of Puerto Rico
  More Information

No publications provided

Responsible Party: National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier: NCT02122094     History of Changes
Other Study ID Numbers: R01DA033673
Study First Received: April 17, 2014
Last Updated: April 22, 2014
Health Authority: United States: National Institutes of Health
Vietnam: Ministry of Health

ClinicalTrials.gov processed this record on October 23, 2014