Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using MSM (STAR)

Columbia University

Status: Completed

Conditions: Sexual Behavior; Substance Abuse

Treatments: Behavioral: Patient Navigation (PN) Intervention; Behavioral: Financial Incentives (FI) Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01790360

AAAI1585

1R01DA032100-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,930 patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,930 participants in 2 patient groups

Patient Navigation (PN)

Active Comparator group

Description:

Behavioral Intervention: 'Patient Navigation (PN) Intervention' participants will receive support from navigators in choosing a provider and remembering to attend appointments

Treatment:

Behavioral: Patient Navigation (PN) Intervention

Financial Incentives (FI)

Experimental group

Description:

Behavioral Intervention: 'Financial Incentives (FI) Intervention' participants will receive gift cards and money for attending clinic visits

Treatment:

Behavioral: Financial Incentives (FI) Intervention