HivLuvHubNCT05708014
Personalized Prevention for Couples: A 16-month Digital RCT
A study testing Intervention LuvHub in people with Hiv and HIV Infections, run by Florida International University at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv, HIV Infections, Sexually Transmitted Infection
- What is being tested?
- Intervention LuvHub
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 778 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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).
Who cannot join
- Does not meet one or more of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: Personalized Prevention for Couples
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).
Read the 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.
- Conditions
- Hiv, HIV Infections, Sexually Transmitted Infection, Sexually Transmitted Diseases, Sexual Behavior, Risk Reduction
- Being tested
- Intervention LuvHub, Waitlist Control LuvHub
- Keywords
- Prevention, Relationship functioning, Adherence, Prevention strategies
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, Sexual Behavior, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention LuvHubBehavioural
Also called 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.
Waitlist Control LuvHubBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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). Receives: Behavioral: Intervention LuvHub |
| Waitlist Control | Experimental | 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). Receives: Behavioral: Waitlist Control LuvHub |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start11 Jan 2023
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 16-month randomized control trial with delayed, educational control condition of 8 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 778 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jason W Mitchell, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708014
- Sponsor's protocol ID
- 5R01MH126880-02
- Other IDs
- 5R01MH126880-04
- Acronym
- LuvHub
- Status last verified
- Sep 2025
- First submitted
- 23 Jan 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Prevention for Couples
- ClinicalTrials.gov ID
- NCT05708014
- Acronym / sponsor ID
- LuvHub / 5R01MH126880-02
- Conditions
- Hiv, HIV Infections, Sexually Transmitted Infection, Sexually Transmitted Diseases, Sexual Behavior, Risk Reduction
- Keywords
- Prevention, Relationship functioning, Adherence, Prevention strategies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 778 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 16-month randomized control trial with delayed, educational control condition of 8 months.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Intervention LuvHubFrom 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). |
| Waitlist Control | Experimental | Behavioral: Waitlist Control LuvHubFrom 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (1 listed)
- Does not meet one or more of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention LuvHubAlso: LuvHubFrom 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. | Behavioural | Intervention |
| Waitlist Control LuvHubAlso: LuvHubFrom 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. | Behavioural | Waitlist Control |
Primary outcome
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.
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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.
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.
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
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.
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason W Mitchell, PhD principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention LuvHub in people with Hiv and HIV Infections, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HIV incidence by comparing results from test kits received at baseline to 16-months. (time frame: Baseline to 16-months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.