Clinical trial NCT01790360: Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using MSM
Official title: Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using Men Who Have Sex With Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Sexual Behavior
Keywords: MSM
HIV
Substance Abuse
Sexual Behavior
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-02-13
Enrollment: 1930
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study will seek and recruit substance-using Black Men who have Sex with Men (MSM) in New York City for Human Immunodeficiency Virus (HIV) testing and will link and retain those who are HIV infected in HIV primary care. The STAR study has two primary objectives: to evaluate the feasibility and effectiveness of Respondent Driven Sampling (RDS) in the substance using Black MSM population for identifying individuals who are HIV infected and not in care; and to assess the relative effectiveness of patient navigation and financial incentives in linkage and retention to HIV care.

Detailed description: The HIV epidemic in the United States most severely affects men who have sex with men (MSM): 61% of all new infections occur in this population. Black MSM bear a disproportionate burden, with prevalence of 28%, in contrast to 19% in MSM overall. Black MSM undergo HIV testing less frequently than other MSM; are less likely to be aware that they are HIV infected; are more likely to experience delays in entry into HIV care; and are less likely to be prescribed antiretroviral therapy (ART) when eligible. These disparities are pronounced in substance-using MSM, as substance users are at elevated risk of late diagnosis and delayed engagement in HIV care. The combination of pervasive stigma associated with MSM behavior and high rates of substance use hinders effective prevention efforts in this population, even as the prevalence of infection in Black MSM in some US cities approaches 50%. Reducing HIV-related disparities in MSM and among Black Americans are National HIV/AIDS Strategy priorities and are essential to the effort to control and prevent HIV/AIDS in the US.

Eligibility criteria: Inclusion Criteria:

* Self-identify as Black, African American, Caribbean Black, or multi-ethnic Black
* Identify as male
* Greater than 18 years old
* Have had sex with a man during the preceding 12 months
* Have ever used illicit drugs or alcohol to intoxication

Exclusion Criteria:

\*Participation in other study assessing linkage and retention in HIV care

Primary outcomes:
measure: Retention Rate (Linkage to Care)
timeFrame: Up to 3 months from HIV diagnosis
Secondary outcomes:
measure: Dollars per patient linked and retained in care
timeFrame: Up to 9 months
measure: Proportion of substance-using Black MSM who are recruited
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Harlem Prevention Center
state: New York
Study officials:
affiliation: Columbia University
name: Wafaa M El-Sadr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franks J, Mannheimer SB, Hirsch-Moverman Y, Hayes-Larson E, Colson PW, Ortega H, El-Sadr WM. Multiple strategies to identify HIV-positive black men who have sex with men and transgender women in New York City: a cross-sectional analysis of recruitment results. J Int AIDS Soc. 2018 Mar;21(3):e25091. doi: 10.1002/jia2.25091.