Intervention Strategies for HIV Prevention

Recruiting 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

424 Participants Needed

Trial Summary

What is the purpose of this trial?

During this 5-year study, stepped-care adaptive interventions will be deployed in three rural syringe service programs in a Sequential Multiple Assignment Randomized Trial (SMART) design to test the optimal intervention pathways for HIV PrEP uptake, defined as PrEP initiation (measured by dispensed prescription for oral PrEP) and persistence in PrEP care (measured by refill verification and biomarker confirmation). The study will be accomplished through three Specific Aims. AIM 1: Compare the relative effectiveness of adaptive interventions (AIs) that begin with Peer-led SBCM-PrEP versus those that begin with CDC-PrEP education plus text messaging (TM) on patient-level PrEP care outcomes (initiation and persistence) at 1-, 3- and 6-months; AIM 2: Estimate and rank the effectiveness of four embedded AIs on PrEP care outcomes at 3- and 6-months: (1) CDC-PrEP education, continue TM for responders, add Mobile Outreach for non-responders (NR); (2) CDC-PrEP education, continue TM for responders, add Peer transitional SBCM for NR; (3) Peer-led SBCM-PrEP, continue TM for responders, add Mobile Outreach for NR; (4) Peer-led SBCM-PrEP, continue TM for responders, add Peer transitional SBCM for NR. AIM 3: Across interventions, examine the effects of age, baseline injection frequency, perceived HIV risk, PrEP interest, SSP utilization patterns, and other factors, in predicting PrEP care outcomes at 1-, 3- and 6-months to inform optimally-tailored intervention strategy recommendations.

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.

What data supports the effectiveness of the treatment CDC-PrEP + Text Messaging, Mobile Outreach, SBCM-PrEP + Text Messaging, T-SBCM for HIV prevention?

Research shows that using text messaging can help people stick to their HIV prevention medication (PrEP) by reminding them to take it, which is crucial for its effectiveness. A study found that a mobile health intervention using text messages significantly reduced missed doses of PrEP, suggesting that this approach can support better adherence to the treatment. ^{1 2 3 4 5}

Is the intervention strategy for HIV prevention using text messaging and PrEP safe for humans?

The studies reviewed did not specifically address safety concerns related to the intervention strategy using text messaging and PrEP, but they did not report any adverse safety issues either. Concerns about side effects were mentioned as a reason for discontinuing PrEP, but no specific safety data was provided. ^{1 3 6 7 8}

What makes the CDC-PrEP + Text Messaging, Mobile Outreach, SBCM-PrEP + Text Messaging, T-SBCM treatment unique for HIV prevention?

This treatment is unique because it combines pre-exposure prophylaxis (PrEP) with text messaging and mobile outreach to enhance adherence and engagement, particularly among groups less likely to use PrEP. The use of technology like text messaging aims to improve communication and support, making it easier for patients to stay on track with their prevention plan. ^{1 3 6 9 10}

Research Team

Hillary L Surratt, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Texting Lost-to-follow-up PrEP Patients from a San Francisco Sexual Health Clinic. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

HIV PrEP Clinician Communication Preferences Among Black Sexual Minority Men. [2022]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The effect of an HIV preexposure prophylaxis panel management strategy to increase preexposure prophylaxis prescriptions. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A Mobile Health Strategy to Support Adherence to Antiretroviral Preexposure Prophylaxis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Context Matters: PrEP Adherence is Associated With Sexual Behavior Among HIV Serodiscordant Couples in East Africa. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Pilot Randomized Controlled Trial of Game Plan for PrEP: A Brief, Web and Text Message Intervention to Help Sexual Minority Men Adhere to PrEP and Reduce Their Alcohol Use. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Short Message Service (SMS) Surveys Assessing Pre-exposure Prophylaxis (PrEP) Adherence and Sexual Behavior are Highly Acceptable Among HIV-Uninfected Members of Serodiscordant Couples in East Africa: A Mixed Methods Study. [2023]

9. China pubmed.ncbi.nlm.nih.gov

Video selection and assessment for an app-based HIV prevention messaging intervention: formative research. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Refining a Multicomponent Intervention to Increase Perceived HIV Risk and PrEP Initiation: Focus Group Study Among Black Sexual Minority Men. [2022]