**Background:** Latino men who have sex with men (LMSM) continue to experience disproportionate HIV burden, with new HIV cases among gay and bisexual Latino men increasing from 6,800 in 2010 to 7,900 in 2019, while rates declined among Black and White gay/bisexual men over the same period. Social and structural conditions—including discrimination, structural stigma, machismo norms, immigration-related stress, and family estrangement—drive HIV risk among LMSM. Evidence from White male couples demonstrates that HIV infection often occurs within primary relationships, and MSM are more likely to engage in condomless anal intercourse with primary partners than outside partners. Despite the promise of couples-based HIV prevention interventions, none have been developed specifically for Latino male couples. This study describes the development and pilot testing of Connecting Latinos en Parejas (CLP), a culturally tailored couples-based biobehavioral HIV prevention intervention.
**Methods:** The CLP intervention was adapted from Connect n' Unite, a couples-based intervention for Black male couples, through a five-step process involving community stakeholders, capturing lived experiences of Latino gay couples, identifying intervention priorities, integrating social cognitive theory into an ecological framework, and adapting materials. The final CLP intervention consists of four sessions covering: (1) personal, cultural, and contextual factors influencing risk (e.g., machismo, substance use, immigration status); (2) communication skills using the GIVE framework and goal setting for sexual health plans; (3) relationship strengthening, identifying triggers for risky sex, and developing action plans; and (4) social support networks and sustaining prevention goals. The Wellness Promotion (WP) attention control condition comprised four sessions on nutrition, fitness, health literacy, and stress management. The pilot RCT enrolled 23 couples (46 individuals) with 1:1 randomization to CLP or WP. Inclusion criteria: age ≥18, residing in Philadelphia Metropolitan Area, Latino-identifying or having a Latino main partner, in a primary relationship ≥3 months, at least one partner reporting three acts of unprotected anal sex, and English/Spanish fluency. Exclusion criteria: severe intimate partner violence in the past year or cognitive/language impairment preventing informed consent. Assessments occurred at baseline, 3 months, and 6 months via REDCap, measuring demographics, sexual behaviors, relationship functioning (Keown-Belous scale), psychological symptoms (Brief Symptom Inventory-18), substance use, and quality of life. Feasibility metrics included recruitment time, retention rates, and intervention completion. Acceptability was assessed through qualitative exit interviews guided by Sekhon's Theoretical Framework of Acceptability.
**Key Results:** At baseline, participants' mean age was 32 (range 20–57), 83% (n=38) were US-born, 22% (n=10) had high school diploma/GED or lower education, 50% (n=23) had yearly income <$30K, and 15% (n=7) experienced homelessness in the past 90 days. Over one-fifth (22%, n=10) were living with HIV; among HIV-negative participants (n=35), only 14% (n=5) had taken PrEP in the prior 90 days. Feasibility metrics were satisfactory: recruitment achieved 23 couples in 6 months (target: 20 couples in 6 months); overall retention at 6-month follow-up was 80.4% (90.0% for CLP, 73.1% for control); and 100% of couples in both arms completed all four sessions (target: ≥75%). Qualitative exit interviews indicated high acceptability across all domains (affective attitude, burden, intervention coherence, ethicality, opportunity costs, perceived effectiveness, self-efficacy). No adverse events were documented. Although not powered for efficacy, there was a significant increase in relationship functioning among couples in the intervention group relative to controls. Trends in the expected directions were observed for stimulant use, psychological symptoms, quality of life, and proportion of protected sex acts (overall and by main vs. outside partners).
**Clinical Implications:** This pilot study demonstrates that CLP is feasible and acceptable for Latino male couples, a population disproportionately affected by HIV yet underserved by existing couples-based interventions. The 100% intervention completion rate and high retention in the CLP arm (90.0%) suggest strong engagement. The significant improvement in relationship functioning—a hypothesized mechanism of action—supports the theoretical framework. Findings highlight the need for remote/video delivery formats to address scheduling challenges, inclusion of biomarkers for adherence, and updating curricula to incorporate long-acting injectable PrEP/ART and on-demand dosing. The study also underscores the importance of community stakeholder engagement. A fully powered efficacy trial is needed to rigorously evaluate CLP's impact on HIV-protected anal sex acts and other outcomes. If efficacious, CLP could fill critical gaps in HIV prevention for Latino male couples, particularly in the 17 non-EHE priority jurisdictions with high Latino HIV burden.