LuvHub: Personalized Prevention for Couples
Study Details
Study Description
Brief Summary
This web-based application, couples-based HIV/STI prevention intervention project will determine efficacy to reduce HIV/STI incidence via uptake of evidence-based strategies and a tailored prevention plan among male couples who are in a relationship (defined as greater than 3 months or more).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 300 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention 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). |
Behavioral: Intervention LuvHub
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.
Other Names:
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| Experimental: Waitlist Control 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). |
Behavioral: Waitlist Control LuvHub
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in HIV incidence by comparing results from test kits received at baseline to 16-months. [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.
- Change in STI incidence by comparing results from test kits received at baseline to 16-months. [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.
- Changes in relationship communication patterns by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months. [Baseline to 8-months, 8-months to 16-months, baseline to 16-months]
Participants will be asked about their mutual constructive communication patterns at all time points, using a validated theoretical measure containing 11 questions with Likert-type scale responses. Changes in mean scores (individual, couple) will be evaluated from baseline to 8-months and 8-months to 16-months.
- Changes in relationship commitment by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months. [Baseline to 8-months, 8-months to 16-months, baseline to 16-months]
Participants will be asked about their relationship commitment at all time points, using a validated theoretical measure containing 13 questions with Likert-type scale responses. Changes in mean scores (individual, couple) from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
- Changes in relationship trust by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months. [Baseline to 8-months, 8-months to 16-months, baseline to 16-months]
Participants will be asked about their relationship trust at all time points, using a validated theoretical measure containing 8 questions with Likert-type scale responses. Changes in mean scores (individual, couple) from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
- Changes in relationship communal coping by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months. [Baseline to 8-months, 8-months to 16-months, baseline to 16-months]
Participants will be asked about their relationship communal coping at all time points, using a validated theoretical measure containing 42 questions with Likert-type scale responses. Changes in mean scores (individual, couple) from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
- Changes in relationship transformation of motivation by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months. [Baseline to 8-months, 8-months to 16-months, baseline to 16-months]
Participants will be asked about their relationship transformation of motivation at all time points, using a validated theoretical measure containing 2 questions. Changes in mean scores (individual, couple) from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
- 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. [Baseline to 8-months, 8-months to 16-months, baseline to 16-months]
Participants will be asked if they created a detailed risk-reduction plan that contains evidence-based strategies with their partner at all time points, using a dichotomous measure containing yes/no responses. Changes in responses (individual, couple) from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
- 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. [Baseline to 8-months, 8-months to 16-months, baseline to 16-months]
Participants will be asked if they created a detailed agreement with their partner at all time points, using a dichotomous measure containing yes/no responses. Changes in responses (individual, couple) from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
- 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. [Baseline to 8-months, 8-months to 16-months, baseline to 16-months]
Participants will be asked whether they had adhered to their risk reduction plan at all time points. Changes to categorical responses (yes/no) at individual and couple levels from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
- Changes in adherence to agreement by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months. [Baseline to 8-months, 8-months to 16-months, baseline to 16-months]
Participants will be asked whether they had adhered to their agreement at all time points. Changes to categorical responses (yes/no) at individual and couple levels from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
- 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. [Baseline to 8-months, 8-months to 16-months, baseline to 16-months]
Participants will be asked to select which evidence-based HIV/STI prevention strategies they are currently using at all time points. Changes to categorical responses (yes/no) at individual and couple levels from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
Eligibility Criteria
Criteria
Inclusion Criteria:
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assigned male at birth and currently identify as male (cis-gender) or gender queer;
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has had condomless anal sex (CAS) within the prior 3 months;
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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.";
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be in a relationship with current partner for at least 3 months;
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be at least 18 years of age;
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not have any history of intimate partner violence since relationship began;
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self-report not feeling coerced by partner to take part in the study activities,
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has own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer);
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lives in the U.S. and plans to live in the U.S. for the next 16 months;
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida International University | Miami | Florida | United States | 33199 |
| 2 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- Florida International University
- University of Michigan
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Jason W Mitchell, PhD, Florida International University
- Principal Investigator: Rob Stephenson, PhD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5R01MH126880-02