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| Name | Class |
|---|---|
| National Center for AIDS/STD Control and Prevention, China CDC | OTHER_GOV |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Phase II: 367 HIV positive MSM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| (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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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);
Besides these criteria, additional criteria for the HIV Linkage and Care pilot Research Clinical Trial are:
Exclusion Criteria:
Having previously been found to be HIV positive based on self-reporting during eligibility screening;
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subjects selected are living or working in Beijing China
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29430845 | Derived | 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. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017321 | Clinical Trials, Phase I as Topic |
| ID | Term |
|---|---|
| D002986 | Clinical Trials as Topic |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
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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).
|
| 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. | 12 months |
| 36 months |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |