Intervention Strategies for HIV Prevention

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hilary L Surratt, PhD

Disqualifiers: HIV positive, Severe renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best methods to encourage and maintain the use of HIV prevention medication, known as PrEP (pre-exposure prophylaxis), among people who use injection drugs. Researchers will compare strategies such as education sessions, text messaging, and peer support to determine which combination most effectively aids in starting and adhering to PrEP. The study seeks participants who have used injection drugs in the past month and have recently used syringe service programs. As an unphased trial, it offers a unique opportunity to contribute to innovative strategies that could significantly enhance public health.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this trial are generally safe for people. The CDC-PrEP + Text Messaging approach uses PrEP (pre-exposure prophylaxis), a medication widely used to prevent HIV, which remains safe when taken as directed. Studies indicate that text messages can help people remember to take their medication on time, which is important for PrEP to work effectively.

Research has shown that the SBCM-PrEP + Text Messaging method improves access to PrEP services. This method also uses text messages to remind people to take their medication, helping them stick to their schedule without any major safety concerns reported.

Mobile Outreach programs have shown promise in making HIV prevention services more accessible, especially for those who might not visit traditional healthcare settings. Studies have not found any significant safety issues with these programs.

Lastly, T-SBCM (Transitional Strengths-Based Case Management) uses peer support to encourage people to stay on PrEP. Research suggests that support from peers can be helpful, with no reports of serious side effects.

Overall, these strategies are well-tolerated and aim to increase the use and consistent use of PrEP, which is crucial for preventing HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative strategies for HIV prevention that combine pre-exposure prophylaxis (PrEP) with supportive services like text messaging, peer support, and mobile outreach. Unlike standard PrEP delivery, which typically involves just medication and basic counseling, these methods aim to enhance adherence and engagement through personalized support. The addition of text messaging and peer-led case management can help address barriers to PrEP uptake and continuity by providing reminders, encouragement, and transitional support. By testing these comprehensive approaches, researchers hope to find more effective ways to prevent HIV, especially in underserved communities.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research shows that PrEP (Pre-exposure Prophylaxis) can greatly lower the chance of acquiring HIV. Studies have found that taking PrEP daily reduces the risk of contracting HIV from sex by 99% and from injection drug use by at least 74%. In this trial, participants may receive CDC-PrEP with Text Messaging, which uses digital tools to help individuals remember to take PrEP regularly, a crucial factor for its effectiveness. Another arm of the trial involves the Strengths-Based Case Management (SBCM) method paired with PrEP and Text Messaging, which has effectively encouraged more individuals to start and continue taking PrEP. Additionally, some participants will engage with mobile outreach programs, which can increase awareness about HIV prevention, making individuals more likely to take protective steps. Overall, these strategies offer effective ways to support individuals in staying on PrEP and reducing their risk of HIV. ^{6 7 8 9 10}

Who Is on the Research Team?

Hillary L Surratt, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for rural individuals who inject drugs and have used a syringe service program in the past month. They must be willing to participate in multiple sessions, not currently on PrEP, without severe kidney issues or chronic hepatitis B, and not HIV positive.

Inclusion Criteria

Self-report of at least one occasion of injection drug use in the past month

Use of the SSP in the past 30 days

Expressed willingness to participate in a multi-session intervention and follow-up

Exclusion Criteria

Being HIV positive

I am currently receiving PrEP treatment.

I have severe kidney problems or chronic hepatitis B.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Intervention

Participants receive either CDC-PrEP education with text messaging or Strengths-based Case Management with text messaging

1 month

1-2 sessions

Adaptive Intervention

Non-responders receive additional support through either Peer Transitional SBCM or Mobile Outreach

1 month

Up to 2 sessions

Follow-up

Participants are monitored for PrEP initiation, persistence, and adherence

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CDC-PrEP + Text Messaging
• Mobile Outreach
• SBCM-PrEP + Text Messaging
• T-SBCM

Trial Overview The study tests different strategies to increase uptake and continued use of HIV prevention medication (PrEP). It compares peer-led support versus CDC-PrEP education with text reminders, adding mobile outreach or peer support if initial methods don't work.

How Is the Trial Designed?

Group I: Strengths Based Case Management - PrEP + Text Messaging + Peer Transitional SBCM (T-SBCM) Experimental Treatment 2 Interventions

SBCM-PrEP + Text Messaging no response by end of month 1, and randomized to rup to 2 sessions of post-linkage transitional SBCM delivered by a peer support specialist

Group II: Strengths Based Case Management - PrEP + Text Messaging + Mobile outreach Experimental Treatment 2 Interventions

SBCM-PrEP + Text Messaging no response by end of month 1, and randomized to up to 2 sessions of post-linkage field session visits delivered by a peer support specialist

Group III: Strengths Based Case Management - PrEP + Text Messaging Experimental Treatment 1 Intervention

Two session Strengths-based Case Management intervention delivered by a peer support specialist to individual clients in the syringe service program

Group IV: CDC-PrEP + Text Messaging + Peer Transitional SBCM (T-SBCM) Experimental Treatment 2 Interventions

CDC-PrEP + Text Messaging; no response by end of month 1, and randomized to rup to 2 sessions of post-linkage transitional SBCM delivered by a peer support specialist

Group V: CDC-PrEP + Text Messaging + Mobile outreach Experimental Treatment 2 Interventions

CDC-PrEP + Text Messaging no response by end of month 1, and randomized to up to 2 sessions of post-linkage field session visits delivered by a peer support specialist

Group VI: CDC-PrEP + Text Messaging Active Control 1 Intervention

1 session PrEP education following CDC guidelines delivered to individual clients in the syringe service program

Who Is Running the Clinical Trial?

Hilary L Surratt, PhD

Lead Sponsor

Trials

4

Recruited

680+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study involving 373 HIV-uninfected partners from serodiscordant couples, SMS surveys revealed that PrEP adherence was high, averaging 92% when participants reported sexual activity, indicating effective monitoring of adherence in real-time.

The findings suggest that while high PrEP adherence is beneficial, it is also associated with increased risk for HIV acquisition during periods of sexual activity, highlighting the importance of ongoing risk assessment in PrEP programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Context Matters: PrEP Adherence is Associated With Sexual Behavior Among HIV Serodiscordant Couples in East Africa. Haberer, JE., Ngure, K., Muwonge, T., et al.[2022]

The Connect4Care (C4C) text messaging intervention did not significantly improve virologic suppression rates among HIV patients after 12 months, with 48.8% in the intervention group compared to 45.8% in the control group.

However, newly diagnosed patients showed higher suppression rates (78.3% vs 45.3%), and the study suggests that patient engagement through responses to text messages may be an important factor in achieving better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net Human Immunodeficiency Virus Clinic: The Connect4Care Trial. Christopoulos, KA., Riley, ED., Carrico, AW., et al.[2022]

The M-Cubed intervention, designed for gay, bisexual, and other men who have sex with men (GBMSM), utilizes mobile technology to deliver tailored HIV prevention messages and link users to healthcare resources, aiming to reduce new HIV infections.

Interviews with 26 GBMSM revealed key themes regarding video message acceptability and comprehension, leading to the selection of 12 effective videos for a randomized controlled trial, highlighting the need for diverse content in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video selection and assessment for an app-based HIV prevention messaging intervention: formative research. Downing, MJ., Wiatrek, SE., Zahn, RJ., et al.[2023]

The PrEP-OI study demonstrated that a panel management intervention, which included PrEP coordinators and a web-based tool, significantly increased the number of PrEP prescriptions from 1.85 to 2.44 per month across 10 primary care clinics in San Francisco.

The intervention also improved PrEP-related discussions, HIV risk assessments, and risk reduction counseling during clinic visits, indicating enhanced overall care for patients at risk of HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an HIV preexposure prophylaxis panel management strategy to increase preexposure prophylaxis prescriptions. Saberi, P., Stoner, MCD., Ming, K., et al.[2023]

Citations

1. stacks.cdc.gov stacks.cdc.gov/view/cdc/159326

Digital HIV Pre-exposure Prophylaxis Interventions All studies showed improved adherence in the intervention arms compared with comparison groups or pre-intervention data. One study also reported improvement in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11260538/

Digital HIV Pre-exposure Prophylaxis Interventions - PMC When taken daily as prescribed, PrEP reduces the risk of getting HIV from sex by 99% and from injection drug use by at least 74%. There is a strong connection ...

3. hiv.gov hiv.gov/blog/digital-health-interventions-increase-adherence-to-hiv-prep

Digital Health Interventions Increase Adherence to HIV PrEP When taken daily as prescribed, PrEP reduces the risk of getting HIV from sex by 99% and from injection drug use by at least 74%.3 Helping ...

4. stacks.cdc.gov stacks.cdc.gov/view/cdc/61244/cdc_61244_DS1.pdf

Quantitative assessment of brief messages about HIV pre- ... This study developed and tested PrEP efficacy messages in a large sample of black and Hispanic/Latino MSM, populations that could greatly ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0376871621007249

Promising outcomes from a cognitive behavioral therapy ... Those who received TXT-CBT reduced HIV-risk behaviors and increased their self-efficacy related to medication adherence. •. TXT-CBT is a potentially scalable ...

6. cdc.gov cdc.gov/stophivtogether/partnerships/toolkit/prepared.html

PrEPared Let's Stop HIV Together Social Media Toolkit #PrEP is highly effective at preventing HIV regardless of your relationship status, and it can be available to you at low or no cost. Get # ...

7. cdc.gov cdc.gov/stophivtogether/partnerships/toolkit/talk-hiv.html

TalkHIV Let's Stop HIV Together Social Media Toolkit This edition of our Let's Stop HIV Together social media toolkit contains ready-to-go messages for posting on Instagram, Facebook, and X (formerly Twitter).

8. cdc.gov cdc.gov/hiv/prevention/prep.html

Preventing HIV with PrEP For receptive vaginal sex and injection drug use, PrEP pills reach maximum protection at about 21 days of daily use. No data are available for ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11239277/

Improving HIV Pre-exposure Prophylaxis Uptake with ... Our review suggests that by using aspects of AI and automation appropriately and wisely, these technologies may accelerate PrEP use and reduce HIV infection.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT06096519

NCT06096519 | Effectiveness and Implementation of Text ... This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-18 ...