What side effects are associated with this type of intervention?

Common treatments for HIV infection, such as antiretroviral therapy (ART), often include drugs like zidovudine, stavudine, lamivudine, and nevirapine. Known side effects of these medications can include gastrointestinal issues (nausea, diarrhea), fatigue, headache, and more severe effects like liver toxicity, lipodystrophy, and neuropathy. The CHW intervention with M-Health component aims to improve adherence by providing continuous support and education, which can help manage these side effects more effectively.

What prior FDA approvals exist?

The FDA has approved numerous antiretroviral drugs for the treatment of HIV infection, including nucleoside reverse transcriptase inhibitors (NRTIs) like zidovudine and lamivudine, non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as efavirenz, protease inhibitors (PIs) like ritonavir, and integrase strand transfer inhibitors (INSTIs) such as dolutegravir. These drugs are often used in combination to form highly active antiretroviral therapy (HAART) regimens. Treatments similar to the CHW intervention with an M-Health component focus on improving adherence to these ART regimens through continuous support and education, leveraging mobile health technologies to provide reminders, counseling, and real-time monitoring of medication adherence.

What other types of research exist?

Promising novel alternatives to CHW interventions with an M-Health component for HIV patients include: 1) Mobile phone-based case management interventions, which have shown feasibility and acceptability in retaining mothers and infants in postpartum HIV care. 2) Assertive community treatment models, which integrate primary care and mental health services to provide comprehensive support. 3) Internet-based interventions, including apps and social network-based programs, which have demonstrated effectiveness in other health domains like smoking cessation and could be adapted for HIV care.

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Behavioral Intervention

INSTACARE for HIV Infection (INSTACARE Trial)

N/A

Recruiting

Led By Sonjia Kenya, EdD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if community health workers using mobile phones can help Black people with poorly controlled HIV manage their condition better.

Who is the study for?

This trial is for Black individuals aged 18 or older with poorly controlled HIV, who are patients at the University of Miami/Jackson Memorial Health System's adult HIV clinic. They must speak English and be identified by their clinician as having uncontrolled viral suppression.

What is being tested?

The study is testing INSTACARE, which involves a Community Health Worker (CHW) using mobile telehealth to help participants achieve long-term control of their HIV infection.

What are the potential side effects?

Since this trial focuses on navigation services rather than medication, it does not have typical drug side effects. However, there may be indirect effects related to privacy concerns or stress from technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Communication Preferences

Number of CHW contacts

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: INSTACARE armExperimental Treatment1 Intervention

Participants in this arm will receive the INSTACARE intervention for three months.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for HIV infection involve antiretroviral therapy (ART), which includes a combination of drugs from various classes such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. These drugs work by inhibiting different stages of the HIV life cycle, thereby reducing the viral load in the body. This is crucial for HIV patients as it helps maintain viral suppression, prevents the progression to AIDS, and reduces the risk of transmission. The Community Health Worker (CHW) intervention with an M-Health component enhances adherence to ART by providing continuous support and education, which is essential for the long-term effectiveness of the treatment.

Effect of female sex work-targeted community-based interventions along the HIV treatment cascade in sub-Saharan Africa: a systematic review protocol.Optimal time for initiation of antiretroviral therapy in asymptomatic, HIV-infected, treatment-naive adults.