Substance AbuseSTARNCT01790360
Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using MSM
A study testing Patient Navigation (PN) Intervention and Financial Incentives (FI) Intervention in people with Substance Abuse and Sexual Behavior, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Sexual Behavior
- What is being tested?
- Patient Navigation (PN) Intervention and Financial Incentives (FI) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,930 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to 17 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participation in other study assessing linkage and retention in HIV care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using Men Who Have Sex With Men.
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.
Read the 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
- Substance Abuse, Sexual Behavior
- Being tested
- Patient Navigation (PN) Intervention, Financial Incentives (FI) Intervention
- Keywords
- MSM, HIV, Substance Abuse, Sexual Behavior
- Medical subject headings
- Substance-Related Disorders, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigation (PN) InterventionBehavioural
Also called PN Intervention, PN
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.
Financial Incentives (FI) InterventionBehavioural
Also called FI Intervention, FI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Financial Incentives (FI) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months from HIV diagnosis
Secondary outcomes (2)
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.
Measured: Up to 9 months
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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJul 2011
- Primary completionSep 2016
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,930 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Wafaa M El-Sadr, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790360
- Sponsor's protocol ID
- AAAI1585
- Other IDs
- 1R01DA032100-01
- Acronym
- STAR
- Status last verified
- Apr 2022
- First submitted
- 7 Jan 2013
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29537178
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using Men Who Have Sex With Men.
- ClinicalTrials.gov ID
- NCT01790360
- Acronym / sponsor ID
- STAR / AAAI1585
- Conditions
- Substance Abuse, Sexual Behavior
- Keywords
- MSM, HIV, Substance Abuse, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,930 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2011 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation (PN) | Active comparator | Behavioral: Patient Navigation (PN) InterventionBehavioral Intervention: 'Patient Navigation (PN) Intervention' participants will receive support from navigators in choosing a provider and remembering to attend appointments |
| Financial Incentives (FI) | Experimental | Behavioral: Financial Incentives (FI) InterventionBehavioral Intervention: 'Financial Incentives (FI) Intervention' participants will receive gift cards and money for attending clinic visits |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in other study assessing linkage and retention in HIV care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Navigation (PN) InterventionAlso: PN Intervention, PNPatient 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. | Behavioural | Patient Navigation (PN) |
| Financial Incentives (FI) InterventionAlso: FI Intervention, FIAfter 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. | Behavioural | Financial Incentives (FI) |
Primary outcome
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.
2 secondary outcomes
Dollars per patient linked and retained in care
Time frame: Up to 9 months
Proportion of substance-using Black MSM who are recruited
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 29537178Franks 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaa M El-Sadr, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation (PN) Intervention and Financial Incentives (FI) Intervention in people with Substance Abuse and Sexual Behavior, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (Linkage to Care) (time frame: Up to 3 months from HIV diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01790360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.