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Completed

NCT Number: NCT01790360

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Harlem Prevention Center

New York, 10027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PN Intervention, 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.

Other names: FI Intervention, FI

Primary outcomes

  1. Retention Rate (Linkage to Care)

    Time frame: 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 outcomes

  1. Dollars per patient linked and retained in care

    Time frame: 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.

  2. Proportion of substance-using Black MSM who are recruited

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using Men Who Have Sex With Men.

Acronym: STAR

Important dates

Study start
2011
Primary completion
2016
Study completion
2021
First posted
Feb 13, 2013
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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