A Habit-formation and Gamification Intervention to Improve ART Adherence Among MSM HIV Patients in Mexico
NCT03410680 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184
Last updated 2021-09-09
Summary
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.
Conditions
Interventions
- BEHAVIORAL
-
FUERTES
The intervention focuses on antiretroviral therapy habit-formation among MSM living with HIV
Sponsors & Collaborators
-
Hospital Civil Juan I. Menchaca
collaborator OTHER -
Hospital General de Occidente
collaborator OTHER -
CAPASITS Villahermosa
collaborator UNKNOWN -
Instituto Nacional de Salud Publica, Mexico
lead OTHER
Principal Investigators
-
Sergio Bautista-Arredondo, MSc · National Institute of public Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-05
- Primary Completion
- 2019-11-20
- Completion
- 2024-12-01
Countries
- Mexico
Study Locations
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