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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wafaa Mahmoud El-Sadr, Columbia University
ClinicalTrials.gov Identifier:
NCT01790360
First received: January 7, 2013
Last updated: February 11, 2013
Last verified: February 2013

January 7, 2013
February 11, 2013
July 2011
April 2015   (final data collection date for primary outcome measure)
Retention Rates (Linkage to Care) [ Time Frame: Up to 3 months from HIV diagnosis ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01790360 on ClinicalTrials.gov Archive Site
  • Dollars per patient linked and retained in care [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
STAR - Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using MSM
Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using Men Who Have Sex With Men.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • Substance Abuse
  • Sexual Behavior
  • Behavioral: Patient Navigation (PN) Intervention
    Patient Navigation is defined as an individual relationship between a navigator and participant to promote retention in the continuum of HIV care . For this study, three experienced navigators will be hired. Their primary role will be to ensure that participants are linked to an HIV primary care provider, that they attend at least one scheduled visit within three months of receiving a confirmed HIV diagnosis, and that they are retained in care (as defined by attending three HIV visits within nine months of diagnosis). To promote linkage to HIV care, navigators will help participants identify material and other barriers to accessing care and will work with participants to overcome those barriers.
    Other Name: PN
  • Behavioral: Financial Incentives (FI) Intervention
    After confirmation that they have completed their first HIV primary care visit, Financial Incentive participants will receive a gift card. Additionally, the coordinator will flip a coin and give participants a bonus gift card if the coin flip comes up heads. Participants who attend the second HIV primary care visit will receive a gift card. Patients who attend a third HIV primary care visit will receive a gift card. Study staff will be responsible for confirming participants' attendance at appointments.
    Other Name: FI
  • Experimental: Financial Incentives
    Financial incentives participants will receive money for attending clinic visits.
    Intervention: Behavioral: Financial Incentives (FI) Intervention
  • Active Comparator: Patient Navigation
    Patient navigation participants will receive support from navigators in choosing a provider and remembering to attend appointments.
    Intervention: Behavioral: Patient Navigation (PN) Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
April 2015
April 2015   (final data collection date for primary outcome measure)

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

Male
18 Years and older
Yes
United States
 
NCT01790360
AAAI1585, 1R01DA032100-01
No
Wafaa Mahmoud El-Sadr, Columbia University
Columbia University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Wafaa M El-Sadr, MD Columbia University
Columbia University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP