Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using MSM (STAR)
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|ClinicalTrials.gov Identifier: NCT01790360|
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : April 6, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Substance Abuse Sexual Behavior||Behavioral: Patient Navigation (PN) Intervention Behavioral: Financial Incentives (FI) Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1930 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using Men Who Have Sex With Men.|
|Actual Study Start Date :||July 2011|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||November 17, 2021|
Active Comparator: Patient Navigation (PN)
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
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.
Experimental: Financial Incentives (FI)
Behavioral Intervention: 'Financial Incentives (FI) Intervention' participants will receive gift cards and money for attending clinic visits
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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- 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
*Participation in other study assessing linkage and retention in HIV care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790360
|United States, New York|
|Harlem Prevention Center|
|New York, New York, United States, 10027|
|Principal Investigator:||Wafaa M El-Sadr, MD||Columbia University|
|Responsible Party:||Columbia University|
|Other Study ID Numbers:||
1R01DA032100-01 ( U.S. NIH Grant/Contract )
|First Posted:||February 13, 2013 Key Record Dates|
|Last Update Posted:||April 6, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|