NCT05873855

Brief Summary

This digital couples-based HIV/STI prevention intervention project will determine preliminary efficacy to improve uptake of evidence-based strategies and a tailored prevention plan among cisgender 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
148

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Dec 2022

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

December 27, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

May 15, 2023

Last Update Submit

July 23, 2025

Conditions

HIV InfectionsHivSexually Transmitted Infections (Not HIV or Hepatitis)Sexually Transmitted DiseasesSexual BehaviorRisk Reduction

Keywords

preventionrelationship functioningadherenceprevention strategies

Outcome Measures

Primary Outcomes (8)

  • Changes in the creation of a detailed risk reduction plan by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-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 number of individuals and couples who create a detailed risk reduction plan from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.

    baseline to 3-months, 3-months to 6-months, and baseline to 6-months

  • Changes in the creation of a detailed agreement by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-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 number of individuals and couples who create a detailed sexual agreement from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.

    baseline to 3-months, 3-months to 6-months, and baseline to 6-months.

  • Changes in adherence to risk-reduction plan by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-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 3-months, 3-months to 6-months, and baseline to 6-months.

    baseline to 3-months, 3-months to 6-months, and baseline to 6-months.

  • Changes in adherence to agreement by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-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 3-months, 3-months to 6-months, and baseline to 6-months.

    baseline to 3-months, 3-months to 6-months, and baseline to 6-months

  • Changes in the number of evidence-based prevention strategies being used over time by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-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 3-months, 3-months to 6-months, and baseline to 6-months.

    baseline to 3-months, 3-months to 6-months, and baseline to 6-months

  • Change in HIV incidence by comparing results from testing at baseline to 6-months.

    Participants will be asked to provide sample to test for HIV at baseline and 6-months. Count: New HIV diagnosis via testing at follow-up occurring 6 months after baseline randomization.

    baseline to 6 months

  • Change in STI incidence by comparing results from testing at baseline to 6-months.

    Participants will be asked to provide sample to test for HIV at baseline and 6-months. Count: New STI diagnosis via testing at follow-up occurring 6 months after baseline randomization.

    baseline to 6 months

  • Changes in relationship mutual constructive communication (MCC) patterns by comparing responses from baseline to 3-months, 3-months to 6-months, and baseline to 6-months.

    Participants will be asked about their MCC patterns at all time points, using a validated theoretical measure containing 11 questions with Likert-type scale responses ranging from 1-9. Higher scores indicate more positive communication patterns. Changes in mean scores (individual, couple) will be evaluated from baseline to 3-months and 3-months to 6-months.

    baseline to 3-months, 3-months to 6-months, and baseline to 6-months

Study Arms (2)

Intervention

EXPERIMENTAL

From baseline to 6 months, participants randomized to the intervention arm will have access to the P3 web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessments that will occur at 3 months and 6 months.

Behavioral: Para ti, para mi, para nosotros (P3)

Waitlist Control

EXPERIMENTAL

From baseline to 3-months, participants in the waitlist control condition will have access to the P3 web app for post-baseline assessment of 3 months and the resources section. From 3 months to 6 months, participants randomized to the waitlist control arm will then have access to the P3 web app intervention and all of its contents (5 modules, resources, etc.), including post-baseline assessment that will occur at 6 months.

Behavioral: Waitlist Control Para ti, para mi, para nosotros (P3)

Interventions

Para ti, para mi, para nosotros (P3)BEHAVIORAL

From day 1 to day 180 (i.e., entire 6-month duration, post baseline) of the pilot trial, participants randomized to the intervention arm will have access to use the five modules as directed. The P3 intervention includes modules focused on topics of: HIV/STI prevention, sexual agreements, communication/decision-making skills, strengthening relationships and creating goals, and physical activity.

Intervention
Waitlist Control Para ti, para mi, para nosotros (P3)BEHAVIORAL

From day 91 to day 180 (i.e., starting after 3-month assessment) of the pilot trial, participants randomized to the waitlist control condition will have access to use the five modules as directed. The P3 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

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:

  • being assigned male at birth and currently identifying as male (cis-gender);
  • having had anal sex with each other in the past 3 months;
  • referring to each other as being in a relationship, defined as "someone you feel emotionally or romantically committed to above all others, and may be referred to as partner, husband, partner, etc.";
  • being in a relationship with each other for 3 months or longer;
  • being at least 18 years of age;
  • not having any history of intimate partner violence since their relationship began;
  • self-reporting not feeling coerced by their partner to take part in the study activities;
  • having their own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer);
  • living in the Lima metro area and planning to live there for the next 6 months;
  • willing to receive an in-person rapid HIV test (if applicable);
  • willing to be tested for other STIs and use swabs to self-collect their own specimens; and
  • willing to attend an in-person appointment at baseline and at 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

Related Publications (1)

  • Mitchell JW, Bursac Z, Diaz D, Reyes Diaz EM, Silva-Santisteban A, Konda KA. Assessing a Couples-Based, Digital HIV Serostatus-Neutral Intervention (Para Ti, Para Mi, Para Nosotros) for Adult Cisgender Sexual Minority Male Couples in Lima, Peru: Protocol for a 6-Month Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 10;13:e63106. doi: 10.2196/63106.

    PMID: 39388228DERIVED

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeSexually Transmitted DiseasesHepatitisSexual BehaviorRisk Reduction Behavior

Condition Hierarchy (Ancestors)

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

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: 6-month pilot randomized controlled trial with delayed, no-attention control condition of 3 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 24, 2023

Study Start

December 27, 2022

Primary Completion

April 26, 2024

Study Completion

June 30, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Findings from aims 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 in early 2025.
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)