- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05708014
Personalized Prevention for Couples: A 16-month Digital RCT (LuvHub)
Personalized Prevention for Couples
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jason W Mitchell, PhD
- Phone Number: (305) 348-7789
- Email: jamitche@fiu.edu
Study Locations
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Florida
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Miami, Florida, United States, 33199
- Florida International University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- assigned male at birth and currently identify as male (cis-gender) or gender queer;
- has had condomless anal sex (CAS) within the prior 3 months;
- 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.";
- be in a relationship with current partner for at least 3 months;
- be at least 18 years of age;
- not have any history of intimate partner violence since relationship began;
- self-report not feeling coerced by partner to take part in the study activities,
- has own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer);
- lives in the U.S. and plans to live in the U.S. for the next 16 months;
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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).
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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). |
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HIV incidence by comparing results from test kits received at baseline to 16-months.
Time Frame: 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. |
Baseline to 16-months
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Change in STI incidence by comparing results from test kits received at baseline to 16-months.
Time Frame: 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. |
Baseline to 16-months
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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.
Time Frame: 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. |
Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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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.
Time Frame: 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. |
Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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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.
Time Frame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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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. |
Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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Changes in adherence to agreement by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
Time Frame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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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. |
Baseline to 8-months, 8-months to 16-months, 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.
Time Frame: 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. |
Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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Changes in relationship communication patterns by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
Time Frame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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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. |
Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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Changes in relationship commitment by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
Time Frame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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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 (range 1-5). Higher scores represent greater commitment to the relationship. Changes in mean scores (individual, couple) from baseline to 8-months, 8-months to 16-months, and baseline to 16-months. Rusbult CE, Martz JM, Agnew CA. The investment model scale: Measuring commitment level, satisfaction level, quality of alternatives, and investment size. Pers Relatsh. 1998;5(4):357-391. No PMID. Rodrigues D, Lopes D. The Investment Model Scale (IMS): further studies on construct validation and development of a shorter version (IMS-S). J Gen Psychol. 2013;140(1):16-28. PMID: 24837343. |
Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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Changes in relationship trust by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
Time Frame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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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 (range: 0-6). Higher scores represent greater trust toward the partner in the relationship. Changes in mean scores (individual, couple) from baseline to 8-months, 8-months to 16-months, and baseline to 16-months. Larzelere RE, Huston TL. The Dyadic Trust Scale: Toward understanding interpersonal trust in close relationships. J Marriage Fam. 1980;42(3):595-604. No PMID. |
Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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Changes in relationship communal coping by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
Time Frame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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Participants will be asked 42 items (range 1-5): outcome efficacy to reduce HIV threat subscale of joint effort (7 items), communication (7 items), and planning and decision-making (7 items); couple efficacy reduce HIV threat subscale of joint effort (7 items), communication (7 items), and planning and decision-making (7 items). Higher scores represent greater attitudes to achieve outcomes or couple's confidence that together they can engage in communal coping efforts. Changes in mean scores (individual, couple) from baseline to 8-months, 8-months to 16-months, and baseline to 16-months. Salazar LF, Stephenson RB, Sullivan PS, et al. Development and validation of HIV-related dyadic measures for men who have sex with men. J Sex Res. 2013;50(2):164-177. PMID: 22206480. |
Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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Changes in relationship transformation of motivation by comparing responses from baseline to 8-months, 8-months to 16-months, and baseline to 16-months.
Time Frame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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Participants will be asked about their relationship transformation of motivation (ToM) at all time points, using 2 questions (range 1-5). ToM measures (1) cognitive and (2) emotional response to the health threat. Higher scores represent greater cognitive response and emotional response, respectively. Changes in mean scores (individual, couple) from baseline to 8-months, 8-months to 16-months, and baseline to 16-months. Salazar LF, Stephenson RB, Sullivan PS, et al. Development and validation of HIV-related dyadic measures for men who have sex with men. J Sex Res. 2013;50(2):164-177. PMID: 22206480. |
Baseline to 8-months, 8-months to 16-months, baseline to 16-months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jason W Mitchell, PhD, Florida International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01MH126880-02 (U.S. NIH Grant/Contract)
- R01MH126880 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Findings from aim 1-3 will be shared via presentation(s) at peer-reviewed national and international conferences, such as the International AIDS Conference, IAS, AIDS Impact, and the International Congress of Behavioral Medicine.
Findings resulting from the analysis of the data related to the 6-month pilot randomized control trial will be shared as Research Papers in leading, peer-reviewed journals, such as: JMIR Mhealth Uhealth, AIDS and Behavior, JAIDS, and Prevention Science.
A de-identified version of the project's final analytic dataset and codebook will be shared and made available via a download link located at the Florida International University Digital Repository.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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