NCT05708014

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
778

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

January 23, 2023

Last Update Submit

September 16, 2025

Conditions

HivHIV InfectionsSexually Transmitted InfectionSexually Transmitted DiseasesSexual BehaviorRisk Reduction

Keywords

PreventionRelationship functioningAdherencePrevention strategies

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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).

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).

Behavioral: Waitlist Control LuvHub

Interventions

Intervention LuvHubBEHAVIORAL

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
Intervention
Waitlist Control LuvHubBEHAVIORAL

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
Waitlist Control

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCisgender men
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV InfectionsSexually Transmitted DiseasesSexual BehaviorRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jason W Mitchell, PhD

    Florida International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants and relationship partner will not know in advance which arm they are assigned and randomized to in the trial.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 16-month randomized control trial with delayed, educational control condition of 8 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 1, 2023

Study Start

January 11, 2023

Primary Completion

August 25, 2025

Study Completion

August 25, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)