Prevention of Transmission of Sexually Transmitted Diseases in the Youth Through Effective Intervention,

March 26, 2016 updated by: Jih-jin Tsai, Kaohsiung Medical University Chung-Ho Memorial Hospital

Chung-Ho Memorial Hospital Kaohsiung Medical University

The data of Taiwan CDC showed the total HIV victims amounted up to 22,020 from 1984 to 2011. Under risk factor analysis, it indicated the increasing victims among MSM (men having sex with men, including homosexuals & bisexuals) cohorts, from 64% of them in 2009 to 72% in 2011. For age stratification of patients, the youth (from 15 to 24 years old) comprised of 18.5% (4078). Among them, 40% are students. MSM are still the main population (over 80%) from 2009 to 2011. Therefore it is crucial to target the young MSM.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purpose: Under the hospital based, and in conjuction with the community, we try to target the young HIV MSM victims and develop the partnership networking to seek for the potential high risk couples to enroll into our intervention.

Materials & Methods: At hospital, though HIV clinic has case manager, however the limitation of space and privacy, we just focus on the HIV patient itself and have limited time to educate patients' sex partners. Therefore, we aimed at enrolling more of the intimate partners thru young HIV MSM victims thru hospital base. We will provide the saliva OraQuick rapid test service to the partners, thus set up the relationship with the study subjects, and then communicate with them and educate them with knowledge of sexual transmitted diseases and sex health. We plan to enroll 200 study subjects till the end of this year. Our co-PI, Prof. Y.M. Chen will also perform HIV gene clustering analysis thru high throughput ultra-deep pyrosequencing among young MSM HIV victims. The other co-PI Prof. P.I. Chou will train the research assistant adopting MSM HIV victim partner follow-up model to approach the study subjects with structured questionnaires. Prof. Chou also collected the study subjects in the northern Taiwan with her own project, thus we can compare and analyze the difference from the locality (North area v.s. South area).

Anticipated work: We aim at enrolling 300 young HIV MSM partners to this OraQuick rapid test, setting up the follow-up model and providing the intervention education of safe sex thru individual case management, group meeting, leader-finding plan and interactive MSM web networking to achieve the preventione of sexual disease transmission in the youth.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Homosexual or bisexual and MSM who have sex.
  2. Age over 15 years old to 30 years old.

Exclusion Criteria:

  1. Women and heterosexual.
  2. AIDS was received within three months of screening those.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMUHIRB-20130061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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