Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Multi-component HIV Intervention Packages for Chinese Men Who Have Sex With Men —Test, Link and Care (TLC) (MP3)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Center for AIDS/STD Control and Prevention, China CDC
Information provided by (Responsible Party):
Sten Vermund, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01904877
First received: July 17, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose
  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. 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

Condition Intervention
HIV/AIDS
Behavioral: Enhancing HIV testing

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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: 36 months ] [ Designated as safety issue: No ]
    To evaluate the efficacy of interactive SMS-II with peer education/counseling intervention for reducing risky sexual behaviors among HIV-infected Chinese MSM over the first year of HIV-care


Biospecimen Retention:   Samples With DNA

HIV RNA will be extracted from plasma and the HIV PR and RT genes will be amplified by a one-step RT-PCR using TaKaRa One Step RNA PCR Kit . The quality of sequences will be evaluated using Sequence Scanner v1.0, and the sequences will be cleaned and assembled by Sequencher (Gene Codes Corporation, Ann Arbor, MI,USA).


Estimated Enrollment: 6000
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: Enhancing HIV testing
SMS-I intervention by cell phones, web advertisement, community outreach, and peer referral strategies to recruit MSM in Beijing City for receiving HIV testing
Other Name: Phase I
Phase II: 312 HIV positive MSM
  • Linking to care:
  • Providing enhanced HIV care.
Behavioral: Enhancing HIV testing
SMS-I intervention by cell phones, web advertisement, community outreach, and peer referral strategies to recruit MSM in Beijing City for receiving HIV testing
Other Name: Phase I

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

subjects selected are living or working in Beijing China

Criteria

Inclusion Criteria:• Men who had sex with another man in the last 12 months based on self-reporting (sex can be defined as oral, anal, or mutual masturbation)(including transgendered women)(including transgendered women);

  • Aged 18 years or older;
  • Living and/or working in the defined districts of municipal Beijing;
  • Able and willing to adequately grant informed consent. For the purposes of this activity participants must consent to questionnaire surveys, receipt of phone messages, and serological testing;
  • Having not previously participated in HIV testing in this study.

Besides these criteria, additional criteria for the HIV Linkage and Care pilot Research Clinical Trial are:

  • Men who are being identified as HIV positive during the testing campaign in Phase I of the study;
  • No plan to leave Beijing in the next 12 months.
  • Willing to comply with study procedures.
  • Having a cell phone and willing to receive study related SMS texts

Exclusion Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904877

Sponsors and Collaborators
Vanderbilt University
National Center for AIDS/STD Control and Prevention, China CDC
Investigators
Study Chair: Sten H Vermund, MD,PhD Vanderbilt Institue for Global Health
Study Director: Han-Zhu Qian, MD,PhD Vanderbilt Institue for Global Health
Study Director: Yiming Shao, MD,PhD Division of Immunology and Microbiology NCAIDS, China CDC
  More Information

No publications provided

Responsible Party: Sten Vermund, MD, PhD, Vanderbilt Institute for Global Health (VIGH), Vanderbilt University, Nashville, TN, USA, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01904877     History of Changes
Other Study ID Numbers: 11914
Study First Received: July 17, 2013
Last Updated: July 17, 2013
Health Authority: United States: Institutional Review Board
China: Ethics Committee

Keywords provided by Vanderbilt University:
HIV testing
linkage
care

Additional relevant MeSH terms:
HIV Antibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014