Web-based HIV Prevention Toolkit for HIV

Overseen By Jason W Mitchell, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Florida International University

Disqualifiers: Intimate partner violence, others

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

Compensation: Varies

Number of Visits: 6

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This digital couples-based HIV/STI prevention intervention project will determine preliminary efficacy to improve uptake of evidence-based strategies and a tailored prevention plan among cisgender male couples who are in a relationship (defined as greater than 3 months or more).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Para ti, para mi, para nosotros (P3) for HIV prevention?

The Positive Health Check (PHC) study showed that a web-based intervention can effectively engage patients in HIV care by providing tailored health messages, with 70.1% of participants completing the intervention and 77.7% selecting behavioral tips to practice. This suggests that web-based tools like P3 could be promising for HIV prevention. ^{1 2 3 4 5}

What makes the P3 treatment unique for HIV prevention?

The P3 treatment is unique because it is a web-based HIV prevention toolkit specifically designed for young Latinas, offering a bilingual and culturally sensitive approach to HIV prevention through technology, which is not commonly found in other treatments. ^{6 7 8 9 10}

Research Team

Jason W Mitchell, PhD

Principal Investigator

Florida International University

Eligibility Criteria

This trial is for cisgender male couples in Lima, Peru who have been in a relationship for over 3 months and are at least 18 years old. They must have had anal sex recently, not experienced partner violence, be willing to test for HIV/STIs, and own a web-connected device.

Inclusion Criteria

Having their own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer)

Having had anal sex with each other in the past 3 months

Living in the Lima metro area and planning to live there for the next 6 months

Exclusion Criteria

Does not meet one or more of the inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm have access to the P3 web app intervention and all of its contents for 6 months

6 months

Post-baseline assessments at 3 months and 6 months

Waitlist Control

Participants in the waitlist control condition have access to the P3 web app for post-baseline assessment of 3 months, then full access from 3 to 6 months

6 months

Post-baseline assessments at 3 months and 6 months

Follow-up

Participants are monitored for changes in adherence, communication, and HIV/STI incidence

6 months

Treatment Details

Interventions

• Para ti, para mi, para nosotros (P3)
• Waitlist Control Para ti, para mi, para nosotros (P3)

Trial Overview The study tests 'Para ti, para mi, para nosotros (P3),' a digital HIV/STI prevention toolkit designed for male couples. It aims to see if the program increases use of proven prevention strategies compared to those on a waitlist.

Participant Groups

Group I: Waitlist Control Experimental Treatment 1 Intervention

From baseline to 3-months, participants in the waitlist control condition will have access to the P3 web app for post-baseline assessment of 3 months and the resources section. From 3 months to 6 months, participants randomized to the waitlist control arm will then have access to the P3 web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessment that will occur at 6 months.

Group II: Intervention Experimental Treatment 1 Intervention

From baseline to 6 months, participants randomized to the intervention arm will have access to the P3 web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessments that will occur at 3 months and 6 months.

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Universidad Peruana Cayetano Heredia

Collaborator

Trials

80

Recruited

62,300+

Findings from Research

In a one-month pilot study involving 97 patients with HIV, the Positive Health Check (PHC) web-based intervention was well-received, with 70.1% of users completing it in an average of 15 minutes.

The intervention effectively engaged patients, with 77.7% selecting behavioral tips and 48.2% making commitments to discuss health questions with their providers, indicating its potential to support HIV care and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Health Check intervention tool usage during a feasibility pilot in HIV primary care clinics. Galindo, CA., Freeman, A., Abdallah, I., et al.[2023]

The C-SAFE program, a computer-delivered sexual health promotion initiative for Latinas, did not show significant changes in sexual behaviors or attitudes after six months, but it did lead to improved mental health days reported by participants.

Participants in the C-SAFE program expressed higher satisfaction with the information presentation and reported a greater likelihood of learning new information compared to the control group, indicating potential benefits in educational engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

C-SAFE: A Computer-Delivered Sexual Health Promotion Program for Latinas. Klein, CH., Kuhn, T., Altamirano, M., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Positive Health Check intervention tool usage during a feasibility pilot in HIV primary care clinics. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Implementation of a couple-based HIV prevention program: a cluster randomized trial comparing manual versus Web-based approaches. [2021]

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

Computerized counseling reduces HIV-1 viral load and sexual transmission risk: findings from a randomized controlled trial. [2022]

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

Utility and Impact of the Implementation of Same-Day, Self-administered Electronic Patient-Reported Outcomes Assessments in Routine HIV Care in two North American Clinics. [2022]

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

Tailored health communication: crafting the patient message for HIV TIPS. [2018]

6. Singapore pubmed.ncbi.nlm.nih.gov

A Pilot, Web-Based HIV/STI Prevention Intervention Targeting At-Risk Mexican American Adolescents: Feasibility, Acceptability, and Lessons Learned. [2020]

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

Patient and staff perspectives on the use of a computer counseling tool for HIV and sexually transmitted infection risk reduction. [2019]

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

C-SAFE: A Computer-Delivered Sexual Health Promotion Program for Latinas. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Getting the right message: a content analysis and application of the health literacy INDEX tool to online HIV resources in Australia. [2021]

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

Assessment of Technology Use and Technology Preferences for HIV Prevention Among Hispanic Women. [2021]