An interventional study of Intervention LuvHub and Waitlist Control LuvHub in Hiv, HIV Infections and Sexually Transmitted Infection, sponsored by Florida International University. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Florida International University · Not applicable, Interventional, and Prevention
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 778 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Florida International University is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Compared within HIV Infections, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
Also known as: 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.
Also known as: LuvHub
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.
Time frame: Baseline to 8-months, 8-months to 16-months, baseline 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.
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.
Time frame: Baseline to 8-months, 8-months to 16-months, 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.
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.
Time frame: Baseline to 8-months, 8-months to 16-months, 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.
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.
Time frame: Baseline to 8-months, 8-months to 16-months, 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.
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.
Time frame: Baseline to 8-months, 8-months to 16-months, 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.
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.
Time frame: Baseline to 8-months, 8-months to 16-months, 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.
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.
Time frame: Baseline to 8-months, 8-months to 16-months, 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.
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.
Time frame: Baseline to 8-months, 8-months to 16-months, 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.
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.
Time frame: 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.
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.
Time frame: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Plan to share: Yes — 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.
Time frame: Data will become available Fall 2026.
Access criteria: User registration will be required in order to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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