HIV/AIDSMP3NCT01904877
Multi-component HIV Intervention Packages for Chinese Men Who Have Sex With Men -Test, Link and Care (TLC)
An observational study of HIV/AIDS, run by Vanderbilt University Medical Center.
Trial summary
1. The number of MSM who are tested for HIV in the 4 study clinics over 12 months will increase compared with historical data from the same 4 clinics over the past 12 months prior to the intervention. 2. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Enhancing HIV testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,760 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jun 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: subjects selected are living or working in Beijing China
Who may be able to join
None listed.
Who cannot join
- Having previously been found to be HIV positive based on self-reporting during eligibility screening;
- Serious psychological disturbance or cognitive impairment interfering with the participant's ability to comply with the study visit schedule and procedures, as judged by the local study clinician;
- Any other medical or psychiatric condition that, in the opinion of the investigator, would make participation in the study unsafe, or otherwise interfere substantially with the study objectives or interpretation.
About this study
Official title: Multi-component HIV Intervention Packages for Chinese Men Who Have Sex With Men -Test, Link and Care (TLC) Version 1.0 Dated 10/15/12
- The number of MSM who are tested for HIV in the 4 study clinics over 12 months will increase compared with historical data from the same 4 clinics over the past 12 months prior to the intervention.
- Persons diagnosed with HIV over the duration of 12 months will have higher CD4 counts at diagnosis than persons diagnosed with HIV over the past 12 months prior to the intervention
- Conditions
- HIV/AIDS
- Being tested
- Enhancing HIV testing
- Keywords
- HIV testing, linkage, care
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhancing HIV testingBehavioural
Also called Phase I
SMS-I intervention by cell phones, web advertisement, community outreach, and peer referral strategies to recruit MSM in Beijing City for receiving HIV testing
| Study group | Role | What they receive |
|---|---|---|
| HIV testing | Enhancing HIV testing: By partnering with the local CDC and the gay community, we will use SMS-I intervention by cell phones, web advertisement, community outreach, and peer referral strategies to recruit MSM in Beijing City for receiving HIV testing. Receives: Behavioral: Enhancing HIV testing | |
| Phase II: 367 HIV positive MSM | * Linking to care: * Providing enhanced HIV care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Primary) phase I: The number of MSM who are tested for HIV in 4 study clinics over 12 months will increase significantly compared with historical data from the same 4 clinics over the past 12 months prior to the intervention
The effect of intervention on the monthly number of MSM who receive HIV testing prior to and after intervention at 4 clinics will be evaluated using a generalized estimating equation (GEE) model with robust variance estimates to account for correlation in outcomes within a clinic
Measured: 12 months
Phase II: A higher proportion of participants in the intervention arm will obtain their CD4 results and ART eligibility assessment in a CDC clinic within 1 month of being diagnosed with HIV than in the comparison arm experienced a local standard of care.
The proportion of participants randomized to the intervention arm who obtain their CD4 count results within 1 month of randomization will be compared to the same proportion in the comparison arm using logistic regression. The primary analysis will adjust for the following baseline covariates: clinic, CD4 count, ART eligibility, self-reported drug abuse, self-reported alcohol abuse, and age.
Measured: 1 month
Secondary outcomes (2)
Phase I: Persons diagnosed with HIV over the duration of 12 months will have higher CD4 counts at diagnosis than persons diagnosed with HIV over the past 12 months prior to the intervention.
We will compare the distribution of CD4 counts immediately after HIV diagnosis for all MSM diagnosed with HIV at one of the 4 clinics for the 12 months during the intervention period versus the 12 months prior to the intervention using a Wilcoxon rank sum test
Measured: 12 month
Phase II:A higher proportion of ART eligible participants in the intervention arm will receive their first HIV medical care within 3 months of diagnosis than in the comparison arm.
A logistic regression analysis will be performed to assess the association between intervention and timely receipt of first HIV medical care among those who are ART eligible (CD4<350). The analysis will adjust for the following baseline covariates: clinic, CD4 count, self-reported drug abuse, self-reported alcohol abuse, and age.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 3,760 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for AIDS/STD Control and Prevention, China CDC
- Responsible party
- Sponsor
- Investigators
- Sten H Vermund, MD,PhD, Study chair, Vanderbilt Institue for Global HealthHan-Zhu Qian, MD,PhD, Study director, Vanderbilt Institue for Global HealthYiming Shao, MD,PhD, Study director, Division of Immunology and Microbiology NCAIDS, China CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904877
- Sponsor's protocol ID
- 11914
- Acronym
- MP3
- Status last verified
- Apr 2017
- First submitted
- 17 Jul 2013
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu Y, Vermund SH, Ruan Y, Liu H, Rivet Amico K, Simoni JM, Shepherd BE, Shao Y, Qian HZ. Peer counselling versus standard-of-care on reducing high-risk behaviours among newly diagnosed HIV-positive men who have sex with men in Beijing, China: a randomized intervention study. J Int AIDS Soc. 2018 Feb;21(2):e25079. doi: 10.1002/jia2.25079.
PubMed 29430845
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-component HIV Intervention Packages for Chinese Men Who Have Sex With Men -Test, Link and Care (TLC) Version 1.0 Dated 10/15/12
- ClinicalTrials.gov ID
- NCT01904877
- Acronym / sponsor ID
- MP3 / 11914
- Conditions
- HIV/AIDS
- Keywords
- HIV testing, linkage, care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,760 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Center for AIDS/STD Control and Prevention, China CDC
- Study start
- Mar 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Jul 2013 (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 number of MSM who are tested for HIV in the 4 study clinics over 12 months will increase compared with historical data from the same 4 clinics over the past 12 months prior to the intervention.
- Persons diagnosed with HIV over the duration of 12 months will have higher CD4 counts at diagnosis than persons diagnosed with HIV over the past 12 months prior to the intervention
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV testing | – | Behavioral: Enhancing HIV testingEnhancing HIV testing: By partnering with the local CDC and the gay community, we will use SMS-I intervention by cell phones, web advertisement, community outreach, and peer referral strategies to recruit MSM in Beijing City for receiving HIV testing. |
| Phase II: 367 HIV positive MSM | – | –* Linking to care: * Providing enhanced HIV care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subjects selected are living or working in Beijing China
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Having previously been found to be HIV positive based on self-reporting during eligibility screening;
- Serious psychological disturbance or cognitive impairment interfering with the participant's ability to comply with the study visit schedule and procedures, as judged by the local study clinician;
- Any other medical or psychiatric condition that, in the opinion of the investigator, would make participation in the study unsafe, or otherwise interfere substantially with the study objectives or interpretation.
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 |
|---|---|---|
| Enhancing HIV testingAlso: Phase ISMS-I intervention by cell phones, web advertisement, community outreach, and peer referral strategies to recruit MSM in Beijing City for receiving HIV testing | Behavioural | HIV testing |
Primary outcome
(Primary) phase I: The number of MSM who are tested for HIV in 4 study clinics over 12 months will increase significantly compared with historical data from the same 4 clinics over the past 12 months prior to the intervention
Time frame: 12 months
The effect of intervention on the monthly number of MSM who receive HIV testing prior to and after intervention at 4 clinics will be evaluated using a generalized estimating equation (GEE) model with robust variance estimates to account for correlation in outcomes within a clinic
Phase II: A higher proportion of participants in the intervention arm will obtain their CD4 results and ART eligibility assessment in a CDC clinic within 1 month of being diagnosed with HIV than in the comparison arm experienced a local standard of care.
Time frame: 1 month
The proportion of participants randomized to the intervention arm who obtain their CD4 count results within 1 month of randomization will be compared to the same proportion in the comparison arm using logistic regression. The primary analysis will adjust for the following baseline covariates: clinic, CD4 count, ART eligibility, self-reported drug abuse, self-reported alcohol abuse, and age.
2 secondary outcomes
Phase I: Persons diagnosed with HIV over the duration of 12 months will have higher CD4 counts at diagnosis than persons diagnosed with HIV over the past 12 months prior to the intervention.
Time frame: 12 month
Phase II:A higher proportion of ART eligible participants in the intervention arm will receive their first HIV medical care within 3 months of diagnosis than in the comparison arm.
Time frame: 12 months
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 5 Apr 2017.
- Derived from this study: PubMed 29430845Liu Y, Vermund SH, Ruan Y, Liu H, Rivet Amico K, Simoni JM, Shepherd BE, Shao Y, Qian HZ. Peer counselling versus standard-of-care on reducing high-risk behaviours among newly diagnosed HIV-positive men who have sex with men in Beijing, China: a randomized intervention study. J Int AIDS Soc. 2018 Feb;21(2):e25079. doi: 10.1002/jia2.25079.
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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.
Sten H Vermund, MD,PhD study chair
Vanderbilt Institue for Global Health
Han-Zhu Qian, MD,PhD study director
Vanderbilt Institue for Global Health
Yiming Shao, MD,PhD study director
Division of Immunology and Microbiology NCAIDS, China CDC
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Vanderbilt University Medical Center.
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 0 inclusion and 3 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 5 Apr 2017. 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?
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?
(Primary) phase I: The number of MSM who are tested for HIV in 4 study clinics over 12 months will increase significantly compared with historical data from the same 4 clinics over the past 12 months prior to the intervention (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01904877, which also lists 1 linked publication.
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 5 Apr 2017.