This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
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: September 26, 2016
Last verified: October 2015
  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 Hepatitis C 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 ]
    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 ]
    Participants in the clinic-based Sexual Health Promotion intervention will return for their test results

  • Intention to access health services [ Time Frame: two years ]
    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


Enrollment: 1166
Study Start Date: May 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (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

Detailed Description:
The intervention is administered in community and clinic settings. The full intervention consists of seven core modules: Sexual Health, Sexual Diversity, HIV/STI Transmission, Behavioral Risk and Risk Reduction, Alcohol and Drugs, Stigma, and HIV/STI and Health Seeking Practices. In the community, outreach is conducted by Health Educators to deliver the intervention modules that young men express and interest in, as well as to provide risk reduction materials including condoms and lubricant. Study interviewers conduct a cross-sectional interview of young male sex workers in community venues (the interviewers and health educators are never present in a venue at the same time), and a random sample of interviewees are invited to a local clinic, where they receive a more detailed interview, the full intervention (delivered one on one by a Health Educator and including all seven modules), a clinical exam, testing for HIV and other STIs (HBV, HCV, gonorrhea, syphilis, chlamydia), onsite treatment, vaccination and referral, and a post-intevention assessment.
  Eligibility

Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes 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

Locations
Vietnam
Hanoi Medical University
Hanoi, Vietnam
Center for Applied Research on Men and Health (CARMAH)
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
National Development and Research Institutes, Inc.
National Institute on Drug Abuse (NIDA)
Hanoi Medical University
University of Puerto Rico
  More Information

Responsible Party: National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier: NCT02122094     History of Changes
Other Study ID Numbers: R01DA033673 ( US NIH Grant/Contract Award Number )
Study First Received: April 17, 2014
Last Updated: September 26, 2016

Additional relevant MeSH terms:
Hepatitis C
Gonorrhea
Syphilis
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Treponemal Infections
Spirochaetales Infections

ClinicalTrials.gov processed this record on June 23, 2017