Clinical trial NCT05708014: Personalized Prevention for Couples: A 16-month Digital RCT
Official title: Personalized Prevention for Couples
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hiv
HIV Infections
Sexually Transmitted Infection
Sexually Transmitted Diseases
Sexual Behavior
Risk Reduction
Keywords: Prevention
Relationship functioning
Adherence
Prevention strategies
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-02-01
Enrollment: 750
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 16-month randomized control trial with delayed, educational control condition of 8 months.
Primary purpose: PREVENTION

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HIV incidence by comparing results from test kits received at baseline to 16-months.
timeFrame: Baseline to 16-months
measure: Change in STI incidence by comparing results from test kits received at baseline to 16-months.
timeFrame: Baseline to 16-months
measure: Changes in relationship communication patterns by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
timeFrame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
measure: Changes in relationship commitment by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
timeFrame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
measure: Changes in relationship trust by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
timeFrame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
measure: Changes in relationship communal coping by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
timeFrame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
measure: Changes in relationship transformation of motivation by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
timeFrame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
measure: Changes in the creation of a detailed risk reduction plan by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
timeFrame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
measure: Changes in the creation of a detailed agreement by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
timeFrame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
measure: Changes in adherence to risk-reduction plan by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
timeFrame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
measure: Changes in adherence to agreement by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
timeFrame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
measure: Changes in the number of evidence-based prevention strategies being used over time by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
timeFrame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Jason W Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References: