Menu
Recruiting NCT06162897

Case Management Dyad

No phase Interventional HIV Pre-exposure Prophylaxis Case Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dyadic Case Management.
Who it may be relevant to
Registry conditions: HIV, Pre-exposure Prophylaxis, Case Management. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Implementation of a Triadic Network Case Management Intervention for Along the Status Neutral HIV Care Continuum

Overview

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

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 men who have sex with men (MSM) or same-sex attraction, gender-diverse persons, and 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.

Interventions

  • 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.

Primary outcome measures

  • Financial wellbeing [Time frame: 18 months]
  • Food Security [Time frame: 18 months]
Secondary outcome measures (2)
  • PrEP Persistence [Time frame: 18 months]
  • Viral Suppression [Time frame: 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Chicago — Chicago

Publications

  • 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. PMID 27516600
  • 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. PMID 28402827
  • 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. PMID 25096896
  • 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: PMID 30768776
  • 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. PMID 31768689
  • 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. PMID 29079949

Identifiers

NCT: NCT06162897 · IRB23-0938 · 5R01MH131476-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗