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

Sponsor

National Development and Research Institutes, Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT02122094

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), Hanoi Medical University (Other), University of Puerto Rico (Other)

1,166

Enrollment

Locations

Arm

Duration (Months)

583

Patients Per Site

14.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Chlamydia Gonorrhea Syphilis Hepatitis C	Behavioral: Sexual Health Promotion Intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1166 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Acceptance of testing [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 [two weeks]
Participants in the clinic-based Sexual Health Promotion intervention will return for their test results
Intention to access health services [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 29 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Hanoi Medical University	Hanoi		Vietnam
2	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Development and Research Institutes, Inc.

ClinicalTrials.gov Identifier:

NCT02122094

Other Study ID Numbers:

R01DA033673

First Posted:

Apr 24, 2014

Last Update Posted:

Sep 28, 2016

Last Verified:

Oct 1, 2015

Additional relevant MeSH terms:

Hepatitis C

Gonorrhea

Syphilis

Study Results

No Results Posted as of Sep 28, 2016