Clinical trial NCT01904877: Multi-component HIV Intervention Packages for Chinese Men Who Have Sex With Men -Test, Link and Care (TLC)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Keywords: HIV testing
linkage
care
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for AIDS/STD Control and Prevention, China CDC
First posted: 2013-07-22
Enrollment: 3760
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects selected are living or working in Beijing China

Brief 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. 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


Eligibility 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.

Primary outcomes:
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
timeFrame: 12 months
measure: 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.
timeFrame: 1 month
Secondary outcomes:
measure: 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.
timeFrame: 12 month
measure: 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.
timeFrame: 12 months
Other outcomes:
measure: 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.
timeFrame: 36 months
Locations:
Study officials:
affiliation: Vanderbilt Institue for Global Health
name: Sten H Vermund, MD,PhD
role: STUDY_CHAIR
affiliation: Vanderbilt Institue for Global Health
name: Han-Zhu Qian, MD,PhD
role: STUDY_DIRECTOR
affiliation: Division of Immunology and Microbiology NCAIDS, China CDC
name: Yiming Shao, MD,PhD
role: STUDY_DIRECTOR
References:
citation: 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.