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

HIV Clinical Trial

Official title:

Implementation of a Sexual Health Intervention for YMSM in Two Vietnamese Cities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122094
• Other study ID #: R01DA033673
• Status: Completed
• Phase: N/A
• First received: April 17, 2014
• Last updated: September 26, 2016
• Start date: May 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2015
• Source: National Development and Research Institutes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardVietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1166
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 29 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chlamydia
• Gonorrhea
• Hepatitis C
• HIV
• Syphilis

Intervention

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

Locations

Country	Name	City	State
Vietnam	Hanoi Medical University	Hanoi
Vietnam	Center for Applied Research on Men and Health (CARMAH)	Ho Chi Minh City

Sponsors (4)

Lead Sponsor	Collaborator
National Development and Research Institutes, Inc.	Hanoi Medical University, National Institute on Drug Abuse (NIDA), University of Puerto Rico

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 hours	No
Primary	Return for test results	Participants in the clinic-based Sexual Health Promotion intervention will return for their test results	two weeks	No
Primary	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	two years	No