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

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ClinicalTrials.gov Identifier: NCT02122094
Recruitment Status : Completed
First Posted : April 24, 2014
Last Update Posted : September 28, 2016
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.

Tracking Information
First Submitted Date  ICMJE April 17, 2014
First Posted Date  ICMJE April 24, 2014
Last Update Posted Date September 28, 2016
Study Start Date  ICMJE May 2013
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02122094 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities
Official Title  ICMJE Implementation of a Sexual Health Intervention for YMSM in Two Vietnamese Cities
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV
  • Chlamydia
  • Gonorrhea
  • Syphilis
  • Hepatitis C
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Behavioral: Sexual Health Promotion Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2016)
1166
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2014)
1500
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 16 Years to 29 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02122094
Other Study ID Numbers  ICMJE R01DA033673( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Development and Research Institutes, Inc.
Study Sponsor  ICMJE National Development and Research Institutes, Inc.
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Hanoi Medical University
  • University of Puerto Rico
Investigators  ICMJE Not Provided
PRS Account National Development and Research Institutes, Inc.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP