Case Management Dyad

HIV Clinical Trial

— CM2  

Official title:

Implementation of a Triadic Network Case Management Intervention for Younger Black Sexual Minority Men

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162897
• Other study ID #: IRB23-0938
• Secondary ID: 5R01MH131476-02
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: November 2023
• Source: University of Chicago
• Contact: Rebecca Eavou
• Phone: 773-834-233
• Email: reavou[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of this study is to test whether dyadic and focused case management will (1) improve financial wellbeing, (2) improve access to food, (3) increase linkage and retention rates for individuals living with HIV or those taking PrEP (PrEP persistence), and (4) increase the proportion of individuals living with HIV who are virally suppressed (viral suppression) when compared to routine Ryan White Non-Medical Case Management.

Description:

The purpose of this research is to test the impact of dyadic, focused case management on financial well-being, access to food, linkage to and retention in care outcomes for individuals living with or vulnerable to HIV. The study population is Black men who have sex with men (MSM) or same-sex attraction, Black gender-diverse persons, and Black cis-gender women living with or at increased vulnerability to HIV.

The study team will be testing the hypotheses that dyadic case management that is focused on financial wellness, will have better outcomes for folks living with or vulnerable to HIV. Analyses will be used to assess the efficacy of the intervention as an emerging practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Black/ African American cis-gender men who have had attraction or sexual activity with a male partner in the past 12 months

• Black/ African American cis-gender women who are living with HIV or vulnerable to HIV (prescribed PrEP or previous sexually transmitted infection (STI) diagnosis)

• Black/African American gender-diverse persons

• Gap in HIV or PrEP care access in the past 24 months, defined as a gap greater than 6 months or detectable viral load at least one time in the past 24 months

• Self-reported financial or food insecurity

Exclusion Criteria:

• Cis-gender men without attraction or sexual activity with a male partner in the past 12 months

• Cis-gender women who are not living with or vulnerable to HIV (prescribed PrEP or previous STI diagnosis)

• non-Black/African American persons

Related Conditions & MeSH terms

• Case Management
• HIV
• Pre-exposure Prophylaxis

Intervention

Behavioral:
• Dyadic Case Management
Subjects enrolled in the intervention arm will be offered focused case management centered around goal setting and future orientation. Subjects will be assigned two case managers to support their goals.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bailey ZD, Krieger N, Agenor M, Graves J, Linos N, Bassett MT. Structural racism and health inequities in the USA: evidence and interventions. Lancet. 2017 Apr 8;389(10077):1453-1463. doi: 10.1016/S0140-6736(17)30569-X. — View Citation

Bouris A, Jaffe K, Eavou R, Liao C, Kuhns L, Voisin D, Schneider JA. Project nGage: Results of a Randomized Controlled Trial of a Dyadic Network Support Intervention to Retain Young Black Men Who Have Sex With Men in HIV Care. AIDS Behav. 2017 Dec;21(12):3618-3629. doi: 10.1007/s10461-017-1954-8. — View Citation

Evans WN, Sullivan JX, Wallskog M. The impact of homelessness prevention programs on homelessness. Science. 2016 Aug 12;353(6300):694-9. doi: 10.1126/science.aag0833. Epub 2016 Aug 11. — View Citation

Lopez JD, Shacham E, Brown T. The Impact of Clinic Policy Attendance and the Ryan White HIV/AIDS Medical Case Management Program on HIV Clinical Outcomes: A Retrospective Longitudinal Study. AIDS Behav. 2020 Apr;24(4):1161-1169. doi: 10.1007/s10461-019-02738-8. — View Citation

Singer AW, Weiser SD, McCoy SI. Does Food Insecurity Undermine Adherence to Antiretroviral Therapy? A Systematic Review. AIDS Behav. 2015 Aug;19(8):1510-26. doi: 10.1007/s10461-014-0873-1. — View Citation

Wheeler DP, Fields SD, Beauchamp G, Chen YQ, Emel LM, Hightow-Weidman L, Hucks-Ortiz C, Kuo I, Lucas J, Magnus M, Mayer KH, Nelson LE, Hendrix CW, Piwowar-Manning E, Shoptaw S, Watkins P, Watson CC, Wilton L. Pre-exposure prophylaxis initiation and adherence among Black men who have sex with men (MSM) in three US cities: results from the HPTN 073 study. J Int AIDS Soc. 2019 Feb;22(2):e25223. doi: 10.1002/jia2.25223. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Financial wellbeing	Proportion of subjects who report improved financial wellbeing (e.g. consistent income, ability to pay bills).	18 months
Primary	Food Security	Proportion of individuals who report improved access to food (e.g. fewer gaps in access to food, reduced concern about access to food).	18 months
Secondary	PrEP Persistence	Proportion of individuals who have engaged in PrEP care regularly (beyond 6 months).	18 months
Secondary	Viral Suppression	Proportion of individuals who have a viral load below 200 copies/mL	18 months

External Links

•   This is the link to the project this study is based on.