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

Not Applicable

Completed

• Conditions: Substance Abuse; Sexual Behavior
• Interventions: Behavioral: Patient Navigation (PN) Intervention; Behavioral: Financial Incentives (FI) Intervention

• Registration Number: NCT01790360
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Primary Completion: 2016-09
• Study Completion: 2021-11-17
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1930

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Navigation (PN)	Patient Navigation (PN) Intervention	Behavioral Intervention: 'Patient Navigation (PN) Intervention' participants will receive support from navigators in choosing a provider and remembering to attend appointments
Financial Incentives (FI)	Financial Incentives (FI) Intervention	Behavioral Intervention: 'Financial Incentives (FI) Intervention' participants will receive gift cards and money for attending clinic visits

Primary Outcome Measures

Name	Time	Method
Retention Rate (Linkage to Care)	Up to 3 months from HIV diagnosis	Linkage to care will be defined as the attendance of at least one scheduled HIV primary care visit within three months of receiving a confirmed HIV diagnosis. Retention in care will be defined as three visits within nine months of HIV diagnosis.

Secondary Outcome Measures

Name	Time	Method
Dollars per patient linked and retained in care	Up to 9 months	We will calculate dollars per patient linked and retained in care to measure cost-effectiveness of the two linkage/retention interventions: costs administering the incentives for the financial incentives arm and staffing costs for the peer navigation arm. All such values will then be adjusted by the opportunity cost of each participant's time. In addition, we will include fixed costs (eg, pamphlets and teaching materials to train the navigators) and the cost of space required to host the navigators.
Proportion of substance-using Black MSM who are recruited	Up to 3 years	Effectiveness of Respondent-Driven Sampling (RDS) for seeking and recruiting substance-using Black MSM: the characteristics of RDS will be estimated using conventional proportion calculations, with confidence intervals.

Trial Locations

Locations (1)

Harlem Prevention Center; 🇺🇸 New York, New York, United States