Case Management Dyad

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV, Pre-exposure Prophylaxis, Case Management

Intervention / Treatment
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* Behavioral: Dyadic Case Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual<br>Participants will be offered the current standard of care, Ryan White Non-Medical Case Management. Case management services are need focused and contact is client initiated. | |
| Experimental: Intervention<br>Participants will receive dyadic case management, specifically they will have two case managers assigned to their case. Case management services will be goal focused and will utilize components from Appreciative Inquiry to orient work to future planning, goals, and financial stability. | Behavioral: Dyadic Case Management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Financial wellbeing | Proportion of subjects who report improved financial wellbeing (e.g. consistent income, ability to pay bills). | 18 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Persistence | Proportion of individuals who have engaged in PrEP care regularly (beyond 6 months). | 18 months | 
| Viral Suppression | Proportion of individuals who have a viral load below 200 copies/mL | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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linkage to care, viral suppression, case management, retention in care, financial wellbeing, food security