# Personalized prevention for couples

> **NIH NIH R01** · FLORIDA INTERNATIONAL UNIVERSITY · 2022 · $499,746

## Abstract

1 SUMMARY / ABSTRACT
 2
 3 Between one to two-thirds of new HIV infections among MSM are attributable to sex with main partners (i.e.,
 4 male couples).1,2 48% of HIV-positive MSM in 5 US cities who were HIV tested in CDC's NHBS project were
 5 unaware of their status,3 suggesting the potential for high levels of unknown sero-discordance among male
 6 couples. Research has also illustrated the role that relationship dynamics (e.g., HIV-specific social support,
 7 constructive communication, sexual agreements) have in shaping male couples' risk for HIV4-41; this has also
 8 been shown longitudinally, strongly suggesting that promoting positive relationship dynamics is a significant
 9 intervention point for reducing HIV transmission among male couples.42-44 There is also evidence at-risk male
10 couples can work together towards shared HIV prevention and care-related goals, including PrEP and U=U/TasP
11 that rely on adherence and resultant viral suppression, leading to increased health and reduced likelihood of
12 onward HIV transmission.45-55 Innovative and tailored solutions are needed to meet the HIV prevention and care
13 needs of at-risk male couples. Our solution is to leverage our strong findings from the preliminary work we
14 conducted in the US (R34 pilot RCT & mixed method acceptability project)59-62 to propose a highly novel, 5-year
15 project to revise and update an existing, eHealth couples-based HIV/STI prevention toolkit intervention that
16 showed promise for reducing couples' HIV risk. The intervention is theoretically grounded in Couples
17 Interdependence Theory for health behavior change.63,64 We will first apply the remaining stages of the ADAPT-
18 ITT model65 with elements of human-centered design66-69 to incorporate at-risk, sero-concordant negative and
19 sero-discordant male couples' prevention and relationship needs while also including the latest science in
20 HIV/STI prevention. We will then conduct a 16-month RCT with 300 at-risk male couples using a delayed,
21 educational control condition of 8 months. Our Specific Aims are to: 1) examine efficacy of the intervention on
22 couples' a) formation and adherence to a risk-reduction plan and agreement, b) relationship functioning, c) self-
23 reported and biomarker confirmed indicators of risk (sexual behavior and STI), and engagement in HIV
24 prevention (PrEP adherence) and care (ART adherence); 2) evaluate use of the intervention over time by using
25 three different data sources; 3) explore moderating and mediating effects on couples' outcomes a-c. Our proposal
26 has high Public Health significance given the HIV disparities and importance of attending to couples' unique
27 relationship and prevention needs. Our innovative, accessible, and tailored intervention will fill a gap in current
28 prevention services by offering couples a personalized program. We believe results from the fully powered RCT
29 will show efficacy toward improving sustained HIV prevention out...

## Key facts

- **NIH application ID:** 10442571
- **Project number:** 5R01MH126880-02
- **Recipient organization:** FLORIDA INTERNATIONAL UNIVERSITY
- **Principal Investigator:** Jason W Mitchell
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $499,746
- **Award type:** 5
- **Project period:** 2021-07-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10442571

## Citation

> US National Institutes of Health, RePORTER application 10442571, Personalized prevention for couples (5R01MH126880-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10442571. Licensed CC0.

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