NCT03410680: FUERTES

A Habit-formation and Gamification Intervention to Improve ART Adherence Among MSM HIV Patients in Mexico

Status unknown NA Last updated 9 September 2021

What this trial tests

NA trial testing FUERTES in HIV in 184 participants. Status unknown.

Timeline

5 December 2017

Primary endpoint
20 November 2019

1 December 2024

Quick facts

Lead sponsor	Instituto Nacional de Salud Publica, Mexico
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	184
Start date	5 December 2017
Primary completion	20 November 2019
Estimated completion	1 December 2024
Sites	3 locations across Mexico

Drugs / interventions tested

• FUERTES

Conditions studied

• HIV — all drugs for HIV →

Sponsor

Instituto Nacional de Salud Publica, Mexico — full company profile →

Who can join

18 and older, male only, with HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In general, several studies show that adherence to antiretroviral therapy (ART) among men who have sex with men (MSM) is low. Yet, high adherence to ART is essential-not only to improve the quality of life and survival rates among MSM living with HIV, but also to reduce HIV transmission among their partners. Our project aims to address this unmet need through a community-based habit-formation intervention, which incorporates elements of gamification. This intervention will provide MSM living with HIV who have been recently diagnosed and linked to care several tools to develop the habit of taking their medication and overcome disruptive adherence events (DAE) that would otherwise lead to treatment abandonment or lower adherence.

Between 2015 and 2017, the investigators conducted a study funded by CONACYT -the Mexican Council for Research-in two Mexican cities to involve MSM living with HIV in the design of an intervention to improve ART adherence. Results from this study show that at the beginning of ART, MSM living with HIV can benefit greatly from a habit-formation community-based intervention that includes support mechanisms to tackle the multiple barriers they face.

Using these findings, the investigators created FUERTES, an intervention with two main components: 1) the provision of a simple tool that MSM can access to learn how to develop an habit of taking their ART drugs, and 2) the support of a trained peer with background in psychology to help teach them how to overcome the myriad of barriers they may face in achieving medication adherence.

This is a multicentre, parallel, randomized, controlled trial. The project's aim is to pilot-test the intervention and document its implementation. Specifically, the investigators will assess the effect of the intervention on ART adherence among MSM living with HIV at four and ten months. Secondary outcomes include viral load and CD4 cell counts. They will also assess the scalability of the intervention by measuring the costs of the intervention. The duration of the project is two years starting December 2017. The researchers hypothesize that the FUERTES intervention will improve ART adherence among MSM living with HIV starting ART by at least 15%, measured by the medication possession ratio.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Accuracy of measures for antiretroviral adherence in people living with HIV.
   Smith R, Villanueva G, Probyn K, Sguassero Y, et al · · 2022 · cited 34× · PMID 35871531 · DOI 10.1002/14651858.cd013080.pub2
2. Effectiveness of an intervention to improve ART adherence among men who have sex with men living with HIV: a randomized controlled trial in three public HIV clinics in Mexico.
   Andrade-Romo Z, La Hera-Fuentes G, Ochoa-Sánchez LE, Chavira-Razo L, et al · · 2024 · PMID 38422450 · DOI 10.1080/09540121.2023.2299322