JMIR Publications

ABSTRACT

Background:

HIV disproportionately affects sexual minority men (SMM; e.g., gay, bisexual, and other men who have sex with men) in Lima, Peru and epidemiological data estimates 32% to 39% of new HIV infections occur among adult, cisgender SMM within primary partnerships (i.e., male couples). Most HIV prevention-care research in Lima, Peru has focused on SMM as individuals, and not couples. 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 intervention (DHI) for adult, cisgender sexual minority male couples in Lima, Peru. P3 is designed to facilitate couples with skill-building, communication, decision-making, and working together to form and adhere to a detailed prevention-care plan that aligns with their explicit sexual agreement. P3 is theoretically informed, self-guided, directed, sequential, and fully automated.

Objective:

This pilot randomized controlled trial (RCT) aims to examine the preliminary effects of P3 on couples’ formation and adherence to a detailed prevention-care plan containing evidence-based strategies (e.g., routine testing, PrEP, ART/U=U) that also aligns with their explicit sexual agreement over time. In addition, feasibility for enrollment and retention, and couples’ acceptability of P3 will also be assessed.

Methods:

The research implements a prospective, 6-month pilot RCT with a 3-month delayed control condition. 60 eligible, consented, and enrolled SMM couples will be randomized to one of two conditions post baseline. Couples randomized to the unmatched, delayed control condition will receive access to the P3 intervention use during the last 3 months of the trial after the 3-month assessment. Couples randomized to the immediate intervention condition will immediately receive access to P3 for use for 6 months. Study assessments will occur at baseline and months 3 and 6.

Results:

The 6-month pilot RCT is ongoing. Recruitment, enrollment, and data collection began in January 2023 and commenced in April 2024. A total of 74 adult, cisgender SMM couples met all inclusion criteria, provided consent, and were enrolled in the pilot RCT. Retention was 92% at month 6 (N=68/74 couples). Data are currently being analyzed to address the three Specific Aims regarding feasibility, acceptability, and preliminary efficacy.

Conclusions:

Findings from this research will reveal whether couples deemed P3 to be acceptable as a couples-based, digital HIV serostatus neutral intervention. Findings will also highlight the preliminary efficacy that the intervention had on couples managing their vulnerability to HIV and other STIs over time via alignment of their prevention-care plan and sexual agreement. Future directions of P3, pending findings from the pilot trial, will continue to focus on addressing the existing gap in prevention-care services for couples in the local context. Clinical Trial: The pilot RCT has been registered on ClinicalTrials.gov [NCT05873855].