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

Recruiting
18 years of age
Male
Phase N/A

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Overview

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).

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.

Eligibility

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 details

HIV Infections, Hiv, Sexually Transmitted Infections (Not HIV or Hepatitis), Sexually Transmitted Diseases, Sexual Behavior

NCT05873855

Florida International University

12 April 2024

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