Personalized Prevention for Couples: A 16-month Digital RCT (LuvHub)

Florida International University (FIU)

Status: Completed

Conditions: Sexually Transmitted Diseases; Sexually Transmitted Infection; Sexual Behavior; Risk Reduction; HIV Infections; Hiv

Treatments: Behavioral: Intervention LuvHub; Behavioral: Waitlist Control LuvHub

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05708014

5R01MH126880-04 (U.S. NIH Grant/Contract)

5R01MH126880-02

Details and patient eligibility

About

This couples-based, digital health intervention project is serostatus neutral and seeks to determine efficacy for: a) use and adherence to evidence-based HIV/STI prevention-care strategies; b) creation and adherence to a tailored prevention-care plan; c) creation and adherence to a tailored sexual agreement; and d) improvements in other relationship dynamics among male couples who are in a relationship (defined as greater than 3 months or more).

Full description

The project draws on our strong findings from the preliminary work we conducted in the US (R34 pilot randomized control trial & mixed method acceptability project). The 5-year project will revise and update an existing digital health couples-based HIV/STI prevention toolkit intervention that showed promise for reducing couples' HIV risk. The intervention is theoretically grounded in Couples Interdependence Theory for health behavior change. The project is a 16-month randomized control trial with 375 at-risk male couples using a delayed, educational control condition of 8 months. Our Specific Aims are to: 1) examine efficacy of the intervention on couples' a) formation and adherence to a risk-reduction plan and agreement, b) relationship functioning, c) self-reported and biomarker-confirmed indicators of risk (sexual behavior and STI), and engagement in HIV prevention (PrEP adherence) and care (ART adherence); 2) evaluate use of the intervention over time by using three different data sources; 3) explore moderating and mediating effects on couples' outcomes a-c. The project has high Public Health significance given the HIV disparities and the importance of attending to couples' unique relationship and prevention needs.

Enrollment: 778 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. assigned male at birth and currently identify as male (cis-gender) or gender queer;
2. has had condomless anal sex (CAS) within the prior 3 months;
3. both partners endorse being in a relationship with one another, defined as "someone you feel emotionally or romantically committed to above all others, and may be referred to as partner, husband, boyfriend etc.";
4. be in a relationship with current partner for at least 3 months;
5. be at least 18 years of age;
6. not have any history of intimate partner violence since relationship began;
7. self-report not feeling coerced by partner to take part in the study activities,
8. has own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer);
9. lives in the U.S. and plans to live in the U.S. for the next 16 months;
10. willing to complete the activities required to obtain and mail back their biomedical data (i.e., self-administer a rapid HIV test (if applicable), willing to use swabs to self-collect their own specimens for STI testing, willing to provide dried blood spot for ART adherence (if applicable), willing to provide dried blood spot for PrEP adherence (if applicable).

Exclusion criteria

• Does not meet one or more of the inclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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778 participants in 2 patient groups

Intervention

Experimental group

Description:

From baseline to 16-months, participants randomized to the intervention arm will have access to the LuvHub web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessments that will occur every 4 months (4, 8, 12, \& 16-months).

Treatment:

Behavioral: Intervention LuvHub

Waitlist Control

Experimental group

Description:

From baseline to 8-months, participants in the waitlist control condition will have access to the LuvHub web app for post-baseline assessments of 4 and 8 months, and the resources section. From 8-months to 16-months, participants randomized to the waitlist control arm will then have access to the LuvHub web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessments that will occur every 4 months (12 \& 16-months).

Treatment:

Behavioral: Waitlist Control LuvHub