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.
Darrell P Wheeler, Sheldon D Fields, Geetha Beauchamp...
https://pubmed.ncbi.nlm.nih.gov/30768776/Actively Recruiting
Led by University of Chicago · Updated on 2026-07-21
180
Participants Needed
1
Research Sites
39 weeks
Total Duration
This research aims to evaluate the impact of dyadic, focused case management on improving financial wellbeing, access to food, and HIV care outcomes for people living with or vulnerable to HIV. The study includes men who have sex with men, gender-diverse persons, and cis-gender women at increased risk or living with HIV. Researchers will compare this approach to routine Ryan White Non-Medical Case Management to see if it leads to better care retention and viral suppression. Participants will be randomly assigned to one of two groups. One group receives the usual Ryan White Non-Medical Case Management, which is client-initiated and focused on needs. The other group receives dyadic case management, where two case managers work together with the participant focusing on goal setting, future planning, and financial stability using techniques like Appreciative Inquiry. Throughout the 18-month study period, participants will be monitored for changes in financial wellbeing and food security as primary outcomes. Secondary outcomes include persistence with PrEP treatment and rates of viral suppression among those living with HIV. Researchers will track these measures to assess how the interventions affect participants health and wellbeing over time.
CONDITIONS
Case Management Dyad
R
Rebecca Eavou
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University of Chicago
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Dyadic Case Management (Intervention Arm) | Treatment as Usual |
|---|---|---|
| What it is | A structured case management intervention delivered by two assigned case managers, focusing on goal setting and future orientation for participants with gaps in HIV or pre-exposure prophylaxis (PrEP) care and social needs. | Standard care for adults with a gap in HIV or PrEP care and financial or food insecurity, without any additional trial-provided case management. |
| Role in the trial | Participants randomized to receive the dyadic case management program. | Participants randomized to continue usual care without the case management intervention. |
| Primary use or purpose | Intended to improve financial wellbeing, food security, and HIV or PrEP care engagement in adults facing access barriers. | Represents current standard care practices for adults with gaps in HIV or PrEP care, financial or food insecurity, without added programmatic case management. |
| How it is given or performed | Participants are assigned two case managers who work together with them on goal setting and addressing financial, food, and healthcare needs through coordinated planning and ongoing support. | Participants continue with their existing access to care, which may include clinic visits, case manager contact if available, and standard community or clinic-based support. |
| Evidence status | Effectiveness of the two-case manager, dyadic approach is under investigation in this trial; no published results are available yet for this specific structure. | Medical case management, particularly through programs such as the Ryan White HIV/AIDS Program, has been associated with improvements in engagement, viral suppression, and retention in HIV care, though outcomes may vary by population and program details. |
| Important limitations | As the intervention is still under study, its effectiveness for financial, food, and care outcomes in this specific population is not yet known. Results may not be generalizable beyond the study setting without additional external evidence. | Standard care, even when including routine case management, may not fully address complex social barriers or engagement gaps in all populations, such as those experiencing food or financial insecurity. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 18 months
Participants receive either standard Ryan White Non-Medical Case Management or dyadic case management with two case managers focused on financial wellness and goal setting.
Regular contact with case managers as needed
Duration - 18 months
Researchers monitor financial wellbeing, food security, PrEP persistence, and viral suppression over the 18-month period.
Periodic assessments throughout study duration
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Darrell P Wheeler, Sheldon D Fields, Geetha Beauchamp...
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https://pubmed.ncbi.nlm.nih.gov/25096896/Julia D López, Enbal Shacham, Tawnya Brown
https://pubmed.ncbi.nlm.nih.gov/31768689/Alida Bouris, Kaitlyn Jaffe, Rebecca Eavou...
https://pubmed.ncbi.nlm.nih.gov/29079949/William N Evans, James X Sullivan, Melanie Wallskog
https://pubmed.ncbi.nlm.nih.gov/27516600/University of Chicago
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborating Sponsor