Personalized Prevention for Couples: A 16-month Digital RCT

HIV Infections Clinical Trial

— LuvHub  

Official title:

Personalized Prevention for Couples

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05708014
• Other study ID #: 5R01MH126880-02
• Secondary ID: R01MH126880
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) improvements in other relationship dynamics among male couples who are in a relationship (defined as greater than 3 months or more).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: August 31, 2025
• Est. primary completion date: July 26, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hiv
• HIV Infections
• Infections
• Risk Reduction
• Sexual Behavior
• Sexually Transmitted Diseases
• Sexually Transmitted Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 16-months
Primary	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.	Baseline to 16-months
Primary	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.	Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Primary	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.	Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Primary	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.	Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Primary	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.	Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Primary	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.	Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Primary	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.	Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Primary	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.	Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Primary	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.	Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Primary	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.	Baseline to 8-months, 8-months to 16-months, baseline to 16-months
Primary	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.	Baseline to 8-months, 8-months to 16-months, baseline to 16-months