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

NCT ID: NCT01904877

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-06-30

Brief Summary

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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

Detailed Description

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Conditions

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HIV/AIDS

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Enhancing HIV testing

Intervention Type BEHAVIORAL

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.

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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Phase I

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for AIDS/STD Control and Prevention, China CDC

OTHER_GOV

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sten H Vermund, MD,PhD

Role: STUDY_CHAIR

Vanderbilt Institue for Global Health

Han-Zhu Qian, MD,PhD

Role: STUDY_DIRECTOR

Vanderbilt Institue for Global Health

Yiming Shao, MD,PhD

Role: STUDY_DIRECTOR

Division of Immunology and Microbiology NCAIDS, China CDC

References

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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.

Reference Type DERIVED
PMID: 29430845 (View on PubMed)

Other Identifiers

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11914

Identifier Type: -

Identifier Source: org_study_id

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