HIVNCT02069652
Prevention of Transmission of Sexually Transmitted Diseases in the Youth Through Effective Intervention,
A study testing Lifestyle Counseling in people with HIV, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 30 years, men only
- Conditions the study is for
- HIV
- What is being tested?
- Lifestyle Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 2013to Dec 2014
- Phase
- Expanded access
- 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 15 to 30 years
- Men only
- Child, Adult
Who may be able to join
- Homosexual or bisexual and MSM who have sex.
- Age over 15 years old to 30 years old.
Who cannot join
- Women and heterosexual.
- AIDS was received within three months of screening those.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV
- Being tested
- Lifestyle Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle CounselingBehavioural
Lifestyle Counseling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2014 (estimated)
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.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jih-jin Tsai, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069652
- Sponsor's protocol ID
- KMUHIRB-20130061
- Status last verified
- Mar 2016
- First submitted
- 27 Jan 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chung-Ho Memorial Hospital Kaohsiung Medical University
- ClinicalTrials.gov ID
- NCT02069652
- Acronym / sponsor ID
- KMUHIRB-20130061
- Conditions
- HIV
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 24 Feb 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.
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.
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 design
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Male only
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Homosexual or bisexual and MSM who have sex.
- Age over 15 years old to 30 years old.
Key exclusion criteria (2 listed)
- Women and heterosexual.
- AIDS was received within three months of screening those.
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 |
|---|---|---|
| Lifestyle CounselingLifestyle Counseling | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 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.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Counseling in people with HIV, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 29 Mar 2016.