Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities
Primary Purpose
HIV, Chlamydia, Gonorrhea
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Sexual Health Promotion Intervention
Sponsored by
About this trial
This is an interventional treatment trial for HIV
Eligibility 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
Sites / Locations
- Hanoi Medical University
- Center for Applied Research on Men and Health (CARMAH)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sexual Health Promotion Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Acceptance of testing
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
Participants in the clinic-based Sexual Health Promotion intervention will return for their test results
Intention to access health services
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02122094
First Posted
April 17, 2014
Last Updated
September 26, 2016
Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), Hanoi Medical University, University of Puerto Rico
1. Study Identification
Unique Protocol Identification Number
NCT02122094
Brief Title
Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities
Official Title
Implementation of a Sexual Health Intervention for YMSM in Two Vietnamese Cities
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Development and Research Institutes, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), Hanoi Medical University, University of Puerto Rico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Chlamydia, Gonorrhea, Syphilis, Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sexual Health Promotion Intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Sexual Health Promotion Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Acceptance of testing
Description
Participants in the clinic-based Sexual Health Promotion intervention will accept offer of testing for chlamydia, gonorrhea, syphilis, HIV, HBV and Hepatitis C Virus.
Time Frame
2 hours
Title
Return for test results
Description
Participants in the clinic-based Sexual Health Promotion intervention will return for their test results
Time Frame
two weeks
Title
Intention to access health services
Description
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
Time Frame
two years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Hanoi Medical University
City
Hanoi
Country
Vietnam
Facility Name
Center for Applied Research on Men and Health (CARMAH)
City
Ho Chi Minh City
Country
Vietnam
12. IPD Sharing Statement
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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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