Acceptability, Feasibility, and Preliminary Impact of a Web-based, HIV Prevention Toolkit With Cisgender Male Couples in Lima, Peru

Not Applicable

Active, not recruiting

• Conditions: HIV Infections; Sexually Transmitted Infections (Not HIV or Hepatitis); Sexual Behavior; Risk Reduction; Hiv; Sexually Transmitted Diseases
• Interventions: Behavioral: Waitlist Control Para ti, para mi, para nosotros (P3); Behavioral: Para ti, para mi, para nosotros (P3)

• Registration Number: NCT05873855
• Lead Sponsor: Florida International University

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).

Detailed Description

The project draws on our strong findings from the preliminary work we conducted in Lima. The 3-year project will update and adapt 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 6-month pilot randomized control trial with 60 at-risk male couples using a delayed, educational control condition of 3 months. Our Specific Aims are to: 1) Assess feasibility to retain 60 consented and eligible male couples in a 6-month pilot RCT through quantitative measurement of enrollment and retention/attrition rates, and by reason for attrition; 2) Describe acceptability of the adapted toolkit intervention using mixed methods23 from 3 data sources. At last follow-up, partners responses to the Health Information Usability Evaluation Scale24 and other survey items (e.g., 3 things liked best/least about the toolkit, features for improvement) will be captured, along with the additional details they will share about their experiences during the individual-level, qualitative exit interview; 3) Examine preliminary impact of the toolkit intervention on couples': a) formation and adherence to a tailored risk-reduction plan and agreement; b) relationship functioning (e.g., communication); c) use of/adherence to evidence-based HIV/STI prevention strategies; and d) HIV/STI incidence. Preliminary impact will be assessed via changes in couples' outcomes a-d over time between trial arms, and for all couples.

Study Timeline

• Study Start: 2022-12-27
• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-24
• Primary Completion: 2024-04-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

1. being assigned male at birth and currently identifying as male (cis-gender);
2. having had anal sex with each other in the past 3 months;
3. 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.";
4. being in a relationship with each other for 3 months or longer;
5. being at least 18 years of age;
6. not having any history of intimate partner violence since their relationship began;
7. self-reporting not feeling coerced by their partner to take part in the study activities;
8. having their own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer);
9. living in the Lima metro area and planning to live there for the next 6 months;
10. willing to receive an in-person rapid HIV test (if applicable);
11. willing to be tested for other STIs and use swabs to self-collect their own specimens; and
12. willing to attend an in-person appointment at baseline and at 6 months.

Exclusion Criteria

-Does not meet one or more of the inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist Control	Waitlist Control Para ti, para mi, para nosotros (P3)	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.
Intervention	Para ti, para mi, para nosotros (P3)	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.

Primary Outcome Measures

Name	Time	Method
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.	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.
Changes in adherence to agreement by comparing responses 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	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.
Change in HIV incidence by comparing results from testing at baseline to 6-months.	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.
Change in STI incidence by comparing results from testing at baseline to 6-months.	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.
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.	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.
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.	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.
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.	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.
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.	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.

Trial Locations

Locations (1)

Florida International University; 🇺🇸 Miami, Florida, United States