Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using MSM (STAR)
Primary Purpose
Substance Abuse, Sexual Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation (PN) Intervention
Financial Incentives (FI) Intervention
Sponsored by
About this trial
This is an interventional screening trial for Substance Abuse focused on measuring MSM, HIV, Substance Abuse, Sexual Behavior
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
Sites / Locations
- Harlem Prevention Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Patient Navigation (PN)
Financial Incentives (FI)
Arm Description
Behavioral Intervention: 'Patient Navigation (PN) Intervention' participants will receive support from navigators in choosing a provider and remembering to attend appointments
Behavioral Intervention: 'Financial Incentives (FI) Intervention' participants will receive gift cards and money for attending clinic visits
Outcomes
Primary Outcome Measures
Retention Rate (Linkage to Care)
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
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
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.
Full Information
NCT ID
NCT01790360
First Posted
January 7, 2013
Last Updated
April 4, 2022
Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01790360
Brief Title
Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using MSM
Acronym
STAR
Official Title
Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using Men Who Have Sex With Men.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Sexual Behavior
Keywords
MSM, HIV, Substance Abuse, Sexual Behavior
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1930 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Navigation (PN)
Arm Type
Active Comparator
Arm Description
Behavioral Intervention: 'Patient Navigation (PN) Intervention' participants will receive support from navigators in choosing a provider and remembering to attend appointments
Arm Title
Financial Incentives (FI)
Arm Type
Experimental
Arm Description
Behavioral Intervention: 'Financial Incentives (FI) Intervention' participants will receive gift cards and money for attending clinic visits
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation (PN) Intervention
Other Intervention Name(s)
PN Intervention, PN
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Financial Incentives (FI) Intervention
Other Intervention Name(s)
FI Intervention, FI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention Rate (Linkage to Care)
Description
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.
Time Frame
Up to 3 months from HIV diagnosis
Secondary Outcome Measure Information:
Title
Dollars per patient linked and retained in care
Description
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.
Time Frame
Up to 9 months
Title
Proportion of substance-using Black MSM who are recruited
Description
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.
Time Frame
Up to 3 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wafaa M El-Sadr, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harlem Prevention Center
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29537178
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.
Results Reference
derived
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Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using MSM
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