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Integrated Health Services for HIV

(IHS Trial)

JA
ES
Overseen ByEdna S Lampkin, Pharm D.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: My Brother's Keeper, Inc.
Disqualifiers: Critically ill, psychiatrically unstable, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn whether integrating routine, opt-out HIV and STI testing and pre-exposure prophylaxis (PrEP) navigation into primary care increases use of these services among adults ages 18 to 45 receiving care at Federally Qualified Health Centers in Mississippi. The main questions it aims to answer are:

1. Does the integrated model increase HIV and STI testing compared with standard care?

2. Does the integrated model increase PrEP navigation activity for eligible patients?

3. How do patients and clinic staff experience the integrated model in terms of satisfaction, comfort discussing sexual health, and feasibility in daily workflows?

Researchers will compare a standard-care period to a period when the integrated model is in place to see if the integrated model improves service use and patient experience.

Participants will:

1. Receive usual primary care, with HIV/STI testing and PrEP discussions offered as a routine, opt-out part of care during the integrated period

2. Be invited, if eligible, to complete a brief survey about their clinic experience

3. For staff, be invited to take part in a short survey or interview about clinic workflows and the integrated model

Who Is on the Research Team?

JA

June A Gipson, PhD

Principal Investigator

My Brother's Keeper, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 45 years old.
Receiving primary care services at participating Federally Qualified Health Center (FQHC) clinics in Canton or Yazoo City, Mississippi
Able to understand and read English (for participation in surveys and interviews)
See 1 more

Exclusion Criteria

For staff key informants: unable or unwilling to provide informed consent for interviews or surveys
Unable to understand English for consent and survey/interview procedures
I am younger than 18 or older than 45 years old.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard Care

Usual care delivered before implementation of the Integrated Health Services (IHS) model. HIV/STI testing and PrEP navigation occur at provider discretion without standardized workflows or EHR prompts.

12 months

Integrated Care

Care delivered using the Integrated Health Services (IHS) model, incorporating routine opt-out HIV/STI screening, standing orders, EHR prompts, and standardized PrEP navigation workflows.

12 months

Follow-up

Participants are monitored for changes in HIV/STI test uptake and PrEP navigation activity, as well as patient satisfaction and staff feasibility ratings.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Integrated Health Services (IHS)

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Integrated HIV/STI and PrEP CareExperimental Treatment1 Intervention
Group II: Standard CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

My Brother's Keeper, Inc.

Lead Sponsor

University of Mississippi Medical Center

Collaborator

Trials
185
Recruited
200,000+

University of Southern Mississippi

Collaborator

Trials
16
Recruited
3,200+

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