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.
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?

This trial explores whether incorporating HIV and STI testing and pre-exposure prophylaxis (PrEP) guidance into routine primary care increases service usage. It compares regular care to a new approach, Integrated Health Services (IHS), where testing and PrEP discussions occur automatically unless a patient opts out. The study examines how this change affects testing rates, PrEP guidance, and the satisfaction and comfort of patients and clinic staff. Adults aged 18 to 45 who receive care at specific health centers in Mississippi and speak English are suitable candidates for this trial. As an unphased trial, this study offers an opportunity to contribute to innovative healthcare improvements that could benefit many.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on integrating HIV and STI testing into primary care, so it's unlikely that your current medications would be affected.

What prior data suggests that this integrated model is safe for increasing HIV and STI testing and PrEP navigation?

Research has shown that integrating HIV and STI (sexually transmitted infections) services with regular healthcare is generally safe and well-received. Studies have found that this combined approach, which includes regular HIV/STI testing and advice on PrEP (pre-exposure prophylaxis), can increase the use of these health services without causing major issues for patients.

For instance, one study found that adding HIV prevention services to regular healthcare led more healthcare providers to offer PrEP. This suggests that the combined approach can be implemented without significant problems. Although specific details on side effects are not provided, the increased use of services indicates that both patients and healthcare providers find this approach acceptable.

In this trial, there have been no reports of serious safety concerns with these combined health services. Therefore, participants can feel confident about the safety of the approach under study.12345

Why are researchers excited about this trial?

Researchers are excited about the Integrated Health Services (IHS) model for HIV care because it offers a streamlined and standardized approach that current treatment methods lack. Unlike standard care, which relies on provider discretion, IHS incorporates routine opt-out HIV/STI screenings and uses electronic health record (EHR) prompts to ensure consistent care. Additionally, it features standardized PrEP navigation workflows, making preventive measures more accessible and efficient. This integrated method has the potential to improve patient outcomes by reducing missed opportunities for testing and treatment, thus enhancing overall healthcare delivery for individuals at risk of or living with HIV.

What evidence suggests that the Integrated Health Services model is effective for increasing HIV and STI testing and PrEP navigation?

This trial will compare Integrated HIV/STI and PrEP Care with Standard Care. Research has shown that combining health services, such as regular HIV and STI testing with guidance on using PrEP (a medication to prevent HIV), can greatly improve health outcomes. One study found that when these services are combined, the chance of contracting HIV drops significantly, with rates as low as 0.13 cases per 100 people each year. Additionally, offering these combined services in clinics helps reach individuals who might not otherwise get tested or use PrEP. For instance, up to 75% of primary care patients in the U.S. don't get tested for HIV each year, but integrating these services can help close this gap. Overall, providing HIV and STI care along with PrEP advice in primary care settings can make these important health services more effective and widely used.36789

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?

This trial is for adults ages 18 to 45 who get primary care at certain health centers in Canton or Yazoo City, Mississippi, and can read English. Clinic staff involved in patient care may also participate if they work at these sites.

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)

Trial Overview

The study tests whether making HIV/STI testing and PrEP guidance a routine part of primary care increases use of these services compared to usual care. Patients are surveyed about their experience; staff may be interviewed about clinic workflows.

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+

Citations

Effectiveness of PrEP (Pre-Exposure Prophylaxis) Integrated ...

Results: Integrated PrEP services demonstrated high HIV prevention effectiveness, with incidence rates ranging from 0.13 to 0.24 per 100 person- ...

Impact of providing pre-exposure prophylaxis for HIV at clinics ...

Pre-exposure prophylaxis (PrEP) greatly reduces the risk of HIV acquisition, but its optimal delivery strategy remains uncertain.

160 effectiveness of prep in the prevention of stis: a meta- ...

Two studies reported a significant association between PrEP use and increased risk behaviors, such as reduced consistent condom use (OR: 2.1; 95% CI: 1.5–2.9).

Integrated HIV Prevention and Care Plan Guidance, including ...

Improve health outcomes along the HIV care continuum by using data to prioritize people and communities who have been disproportionately ...

A Systematic Review and Meta-Analysis of Real-World Studies

This systematic literature review provides a comprehensive review of HIV-1 epidemiology, PrEP effectiveness, and PrEP use data across key ...

Association of an HIV-Prediction Model with Uptake of ... - PMC

This study's aim was to evaluate the effectiveness of an HIV prediction model in clinical workflows. Outcomes included preexposure prophylaxis (PrEP) ...

Advancing functional and systemic integration of HIV ...

This Series paper examines how the principal functions of HIV prevention—risk-based prioritisation, demand generation, quality service provision ...

WHO releases new module of the PrEP implementation ...

The module provides a framework and practical guidance for decision-makers, programme and facility managers, and health care workers for the ...

Successful Integration of HIV PrEP in Primary Care and ... - PMC

Among 104 providers, the number prescribing PrEP increased from 12 (11.5%) to 51 (49%) and the number of individual patients on PrEP increased ...