What side effects are associated with this type of intervention?

The most common treatments for HIV Pre-Exposure Prophylaxis (PrEP), such as tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC), are generally well-tolerated but can have side effects. These may include gastrointestinal issues like nausea and diarrhea, headaches, and fatigue. Some patients may experience mild decreases in bone mineral density and kidney function, which are typically reversible upon discontinuation of the medication. It is important for patients to discuss these potential side effects with their healthcare provider to ensure appropriate monitoring and management.

What prior FDA approvals exist?

The FDA has approved several antiretroviral medications for HIV Pre-Exposure Prophylaxis (PrEP). The most notable approvals include Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide). These medications are taken once daily and have been shown to be highly effective in reducing the risk of HIV infection in high-risk populations. Both drugs work by inhibiting the reverse transcriptase enzyme, which is crucial for HIV replication. These treatments are similar to those being studied in trials for PrEP interventions.

What other types of research exist?

Promising novel alternatives to HIV PrEP for 2024 include the use of tenofovir alafenamide, which has shown high antiviral efficacy and improved renal and bone safety compared to tenofovir disoproxil fumarate. Additionally, drugs like nevirapine, etravirine, and rilpivirine have been identified as potentially more potent in preventing HIV infection than existing PrEP regimens. These alternatives are currently being evaluated for their safety profiles and efficacy in human trials.

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Behavioral Intervention

Multilevel HIV Prevention Strategy for Increasing PrEP Uptake (STARR-NC Trial)

N/A

Recruiting

Led By Sarah Rutstein, MD, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new way to help people in rural and peri-urban North Carolina start using HIV prevention medication (PrEP). It includes personal help from a navigator, online educational resources, and telehealth services. The goal is to make it easier for people at STI clinics to get and use PrEP.

Who is the study for?

This trial is for individuals assigned male at birth, aged 18-39, who have had sexual activity with a male in the past year and are not currently using PrEP. They must speak English, have daily smartphone access, and have tested HIV-negative within the last 90 days.

What is being tested?

The study tests a strategy to increase PrEP use among participants. It includes randomized trials of PrEP Navigation Services, two versions of HealthMpowerment Digital Health Intervention (basic and enhanced), and Telehealth referrals over three years in rural North Carolina STI clinics.

What are the potential side effects?

While specific side effects are not listed for this intervention strategy as it focuses on service delivery methods rather than medication directly, typical PrEP medications can cause nausea, headache, stomach pain or weight loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Proportion of participants reporting PrEP initiation by 3 months

Secondary study objectives

Average number of condomless anal sex acts protected by PrEP among persons initiating event-driven oral PrEP in the 30 days prior to the 3-month visit.

Average number of condomless anal sex acts protected by PrEP among persons initiating event-driven oral PrEP in the 30 days prior to the 6-month visit.

Average number of consecutive months PrEP used over first 3 months

+18 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: STARR NC Intervention ConditionExperimental Treatment3 Interventions

Intervention arm will receive a multilevel intervention with three components: a PrEP Navigator to facilitate linkage to PrEP services and completion of applications for health insurance/drug assistance; a Digital Health Intervention (DHI) platform (HealthMpowerment); and referral to Telehealth PrEP services as an option for linking to PrEP care. The Intervention Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center; Interactive skill-building health activities; social support newsfeed/group chat; Ask the Expert anonymous health question and answer; Medication Tracker; Health Behavior Tracker; Gamification features for participant engagement. Intervention Arm participants will complete baseline and quarterly follow-up assessments. Intervention Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.

Group II: STARR NC Standard-of-Care Control ConditionActive Control1 Intervention

Standard-of-Care Control arm will receive the standard PrEP referral services available at the STI clinic setting where they were recruited. They will also receive study staff guided support to install the control arm version of the HealthMPowerment DHI platform. The Control Arm version of the DHI includes: Study Timeline and Calendar, publicly-available PrEP locator feature, Dried Blood Spot self-collection kit ordering, Educational Health Resource Center. Control Arm participants will complete baseline and quarterly follow-up assessments. Control Arm participants will complete two Dried Blood Spot self-collection kits at 3 and 6 months.

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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 PrEP, such as tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC), work by inhibiting the reverse transcriptase enzyme, which is essential for HIV replication. By blocking this enzyme, these medications prevent the virus from multiplying and establishing an infection in the body. This mechanism is crucial for PrEP patients as it significantly reduces the risk of contracting HIV when taken consistently, providing a proactive measure to maintain their health and prevent the spread of the virus.