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
  Purpose

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.


Condition Intervention
Substance Abuse
Sexual Behavior
Behavioral: Patient Navigation (PN) Intervention
Behavioral: Financial Incentives (FI) Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using Men Who Have Sex With Men.

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Financial Incentives
Financial incentives participants will receive money for attending clinic visits.
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
Active Comparator: Patient Navigation
Patient navigation participants will receive support from navigators in choosing a provider and remembering to attend appointments.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790360

Locations
United States, New York
Harlem Prevention Center Recruiting
New York, New York, United States, 10027
Contact: Julie Franks, PhD    646-448-0944    jf642@columbia.edu   
Contact: Avelino Loquere, RN    646-448-0941    al2061@columbia.edu   
Principal Investigator: Wafaa M El-Sadr, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Wafaa M El-Sadr, MD Columbia University
  More Information

No publications provided

Responsible Party: Wafaa Mahmoud El-Sadr, Professor of Epidemiology and Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01790360     History of Changes
Other Study ID Numbers: AAAI1585, 1R01DA032100-01
Study First Received: January 7, 2013
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
MSM
HIV
Substance Abuse
Sexual Behavior

ClinicalTrials.gov processed this record on October 20, 2014