Trials / Completed
CompletedNCT01790360
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,930 (actual)
- Sponsor
- Columbia University · Academic / Other
- Sex
- Male
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2016-09-01
- Completion
- 2021-11-17
- First posted
- 2013-02-13
- Last updated
- 2022-04-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01790360. Inclusion in this directory is not an endorsement.