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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool called "Para ti, para mi, para nosotros (P3)," designed to help male couples prevent HIV and other sexually transmitted infections (STIs). The goal is to assess how effectively this tool encourages couples to adopt proven prevention strategies and create a personalized prevention plan. Participants will either use the tool for six months or join a waitlist to use it later. It suits cisgender male couples who have been in a committed relationship for over three months, live in the Lima metro area, and are open to undergoing HIV and STI testing. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance prevention strategies for male couples.

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 prior data suggests that this web-based HIV prevention toolkit is safe?

Research shows that Para ti, para mi, para nosotros (P3), a digital tool designed to help male couples prevent HIV, is safe to use. An earlier study tested this tool's effectiveness in helping couples follow their prevention plans. The study found no major safety issues. Participants expressed satisfaction with the process and encountered no serious problems, indicating that P3 is user-friendly. The goal is to enhance HIV prevention for couples, and the safety results so far are encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the P3 web-based HIV prevention toolkit because it offers a new, accessible way to support HIV prevention efforts. Unlike traditional methods that often require in-person visits or ongoing medication, P3 provides a flexible, digital platform that users can access anytime. This toolkit includes interactive modules and resources designed to engage users in meaningful prevention strategies. The convenience and privacy of a web app make it an appealing option for those who may face barriers to accessing traditional HIV prevention services.

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

Research has shown that the Para ti, para mi, para nosotros (P3) web app is a promising tool for preventing HIV among cisgender male couples. In earlier studies, 90% of couples found the app very helpful, particularly the activity that aids in making agreements. This indicates that couples are comfortable using the app. In this trial, participants in the intervention arm will access the P3 web app and all its contents for six months. Meanwhile, those in the waitlist control arm will initially have limited access, gaining full access after three months. Another study, the Positive Health Check, demonstrated that the app helps people use proven prevention methods. These findings suggest that P3 could effectively assist couples in creating and following a personalized HIV prevention plan. ^{1 2 3 6 7}

Who Is on the Research Team?

Jason W Mitchell, PhD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11502978/

Assessing a Couples-Based, Digital HIV Serostatus ... To help address this critical gap in prevention care, we developed Para Ti, Para Mí, Para Nosotros (P3): a couples-based, digital HIV serostatus ...

2. researchgate.net researchgate.net/publication/384812456_Assessing_a_Couples-Based_Digital_HIV_Serostatus-Neutral_Intervention_Para_Ti_Para_Mi_Para_Nosotros_for_Adult_Cisgender_Sexual_Minority_Male_Couples_in_Lima_Peru_Protocol_for_a_6-Month_Pilot_Randomize

Protocol for a 6-Month Pilot Randomized Controlled Trial Assessing a Couples-Based, Digital HIV Serostatus-Neutral Intervention (Para Ti, Para Mí, Para Nosotros) for Adult Cisgender Sexual Minority ...

3. withpower.com withpower.com/trial/web-based-hiv-prevention-toolkit-for-hiv-ab0d4

Web-based HIV Prevention Toolkit for HIV 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 ...

4. discovery.fiu.edu discovery.fiu.edu/display/person-mitchell-jason

Mitchell, Jason Dr. Mitchell has over 12 years of experience in designing, implementing and evaluating HIV/STI prevention projects with sexual minority male couples and men ...

5. researchgate.net researchgate.net/publication/347779250_Acceptability_of_an_eHealth_HIV_Prevention_Toolkit_among_Male_Couples_in_Lima_Peru

Acceptability of an eHealth HIV Prevention Toolkit among ... Methods: Via individual-level interviews, 90% of couples reported high acceptability of the intervention, and liked the agreement builder activity the most.

6. reporter.nih.gov reporter.nih.gov/project-details/8302236

Project Details - NIH RePORTER The overall objective is to improve the efficacy of STTR strategies by specifically intervening to reduce the impact of HIV transmission risk behaviors among ...

7. researchgate.net researchgate.net/figure/Individual-Satisfaction-with-the-Baseline-HIV-Counseling-and-Testing-Session-by-Study_tbl3_256331396

Individual Satisfaction with the Baseline HIV Counseling ... To help address this critical gap in prevention care, we developed Para Ti, Para Mí, Para Nosotros (P3): a couples-based, digital HIV serostatus-neutral ...