Personalized Prevention for Couples: A 16-month Digital RCT

Florida International University778 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

778

Interventions

Intervention LuvHubBEHAVIORAL

From day 1 to day 487 (i.e., entire 16-month duration, post baseline) of the trial, participants randomized to the intervention arm will have access to use the five modules as directed. The LuvHub intervention includes modules focused on topics of: HIV/STI prevention, sexual agreements, communication/decision-making skills, strengthening relationships and creating goals, and physical activity.

Waitlist Control LuvHubBEHAVIORAL

From day 243 to day 487 (i.e., starting after 8-month assessment) of the trial, participants randomized to the waitlist control condition will have access to use the five modules as directed. The LuvHub intervention includes modules focused on topics of: HIV/STI prevention, sexual agreements, communication/decision-making skills, strengthening relationships and creating goals, and physical activity.

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in HIV incidence by comparing results from test kits received at baseline to 16-months.

Participants will be asked to provide sample to test for HIV at baseline and 16-months, using at-home self-collection test kits. Count: New HIV and STI diagnosis via biomedical testing at follow-up occurring 16 months after baseline randomization.

Time frame: Baseline to 16-months

Change in STI incidence by comparing results from test kits received at baseline to 16-months.

Participants will be asked to provide samples to test for STIs at baseline and 16-months, using at-home self-collection test kits. Count: New HIV and STI diagnosis via biomedical testing at follow-up occurring 16 months after baseline randomization.

Time frame: Baseline to 16-months

Changes in relationship communication patterns by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.

Participants will be asked 11 questions with Likert-type scale responses (range 1-9) at all time points: 3 items for mutual constructive communication (MCC): higher scores represent greater MCC. 8 items for avoidance and withdrawal patterns (AW): higher scores represent greater AW. Changes in mean scores of MCC and AW (individual, couple), respectively, will be evaluated from baseline to 8-months, 8-months to 16-months, and baseline to 16-months. Heavey CL, Brandon ML, Zumtobel DC, et al. The Communication Patterns Questionnaire: The reliability and validity of a constructive communication subscale. J Marriage Fam. 1996;58(3):796-800. No PMID. Futris TG, Campbell K, Nielsen RB, Burwell SR. The Communication Patterns Questionnaire-Short Form: A Review and Assessment. Fam J. 2010;18(3):275-87. No PMID.