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

NCT01904877 | Completed

• 1 other identifier: 11914
• Study Type: observational
• Target: 3,760
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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

Conditions

HIV/AIDS

Keywords

HIV testing; linkage; care

Outcome Measures

Primary Outcomes (2)

• (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

  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.

  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.

  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.

  12 months

Other Outcomes (1)

• 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.

  36 months

Study Arms (2)

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

Phase II: 367 HIV positive MSM

* Linking to care: * Providing enhanced HIV care.

Interventions

Enhancing HIV testing 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

Also known as: Phase I

HIV testing

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

subjects selected are living or working in Beijing China

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Center for AIDS/STD Control and Prevention, China CDC: collaborator

Related Publications (1)

• 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.

  PMID: 29430845 DERIVED

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).

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Clinical Trials, Phase I as Topic

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sten H Vermund, MD,PhD

  Vanderbilt Institue for Global Health

  STUDY CHAIR

• Han-Zhu Qian, MD,PhD

  Vanderbilt Institue for Global Health

  STUDY DIRECTOR

• Yiming Shao, MD,PhD

  Division of Immunology and Microbiology NCAIDS, China CDC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 22, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2016
• Last Updated: April 5, 2017

Record last verified: 2017-04