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

NCT01790360 | Completed

• 2 other identifiers: AAAI15851R01DA032100-01
• Study Type: interventional
• Target: 1,930
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Abuse; Sexual Behavior

Keywords

MSM; HIV; Substance Abuse; Sexual Behavior

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 months from HIV diagnosis

Secondary Outcomes (2)

• Dollars per patient linked and retained in care

  Up to 9 months

• Proportion of substance-using Black MSM who are recruited

  Up to 3 years

Study Arms (2)

Patient Navigation (PN)

ACTIVE COMPARATOR

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

Behavioral: Patient Navigation (PN) Intervention

Financial Incentives (FI)

EXPERIMENTAL

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

Behavioral: Financial Incentives (FI) Intervention

Interventions

Patient Navigation (PN) Intervention BEHAVIORAL

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.

Also known as: PN Intervention, PN

Patient Navigation (PN)

Financial Incentives (FI) Intervention BEHAVIORAL

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.

Also known as: FI Intervention, FI

Financial Incentives (FI)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Harlem Prevention Center

New York, New York, 10027, United States

Location

Related Publications (1)

• 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.

  PMID: 29537178 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Sexual Behavior

Interventions

Patient Navigation; Methods

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Investigative Techniques

Study Officials

• Wafaa M El-Sadr, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: February 13, 2013
• Study Start: July 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: November 17, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

US (1)