HIVNCT02122094
Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities
A study testing Sexual Health Promotion Intervention in people with HIV and Chlamydia, run by National Development and Research Institutes, Inc. at 2 sites in Vietnam.
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… Read more about this study
- Who is it for?
- Ages 16 to 29 years, men onlyHealthy volunteers can take part
- What is being tested?
- Sexual Health Promotion Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,166 participants
- Where
- 2 sitesVietnam
- Study dates
- May 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Born biologically male; age 16-29; exchanged sex for money or other material goods with another man in the past 90 days
Who cannot join
- inability to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Hanoi Medical University
Hanoi, Hanoi
Center for Applied Research on Men and Health (CARMAH)
Ho Chi Minh City, Ho Chi Minh CIty
About this study
Official title: Implementation of a Sexual Health Intervention for YMSM in Two Vietnamese Cities
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.
Read the 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.
- Conditions
- HIV, Chlamydia, Gonorrhea, Syphilis, Hepatitis C
- Being tested
- Sexual Health Promotion Intervention
- Medical subject headings
- Chlamydia Infections, Gonorrhea, Syphilis, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual Health Promotion InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Sexual Health Promotion Intervention | Experimental | 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. Receives: Behavioral: Sexual Health Promotion Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Return for test results
Participants in the clinic-based Sexual Health Promotion intervention will return for their test results
Measured: two weeks
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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startMay 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,166 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Hanoi Medical University, University of Puerto Rico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122094
- Sponsor's protocol ID
- R01DA033673
- Status last verified
- Oct 2015
- First submitted
- 17 Apr 2014
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Sexual Health Intervention for YMSM in Two Vietnamese Cities
- ClinicalTrials.gov ID
- NCT02122094
- Acronym / sponsor ID
- R01DA033673
- Conditions
- HIV, Chlamydia, Gonorrhea, Syphilis, Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,166 participants (actual)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Hanoi Medical University, University of Puerto Rico
- Study start
- May 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sexual Health Promotion Intervention | Experimental | Behavioral: Sexual Health Promotion InterventionThe 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. |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Born biologically male; age 16-29; exchanged sex for money or other material goods with another man in the past 90 days
Key exclusion criteria (1 listed)
- inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual Health Promotion InterventionThe 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 | Behavioural | Sexual Health Promotion Intervention |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual Health Promotion Intervention in people with HIV and Chlamydia, run by National Development and Research Institutes, Inc. at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of testing (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.