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

NCT03410680 | Unknown

• 1 other identifier: 2014-1-233508
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 3

Brief 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

HIV

Keywords

Antiretroviral Therapy; Adherence; HIV; Men who have sex with men; Sexual minorities; habit-formation; gamification

Outcome Measures

Primary Outcomes (2)

• Change in HIV viral load

  Change from Baseline HIV viral load measured through medical chart abstraction (suppressed HIV viral load: ≤ 40 copies/mL).

  Baseline (week 0), 1 month, 4 months, 10 months, 3 years

• Change in CD4 cell count

  Change from Baseline CD4 cell count measured through medical chart abstraction.

  Baseline (week 0), 1 month, 4 months, 10 months, 3 years

Secondary Outcomes (2)

• Change in ART adherence status

  Baseline (1 month), 4 months, 10 months

• Change in antiretroviral therapy habit-strength

  Baseline (1 month), 4 months, 10 months

Study Arms (2)

Control arm

NO INTERVENTION

Patients will receive the standard of care at the clinic. Questionnaires will be applied 4 times in a period of 10 months

Intervention arm

EXPERIMENTAL

Each participant will receive FUERTES for a period of 4 months. It consists of receiving a habit-formation kit, which include an information and habit-formation tool that can be accessed through a web platform, a mobile app and a booklet; b) pill cases; c) a fidget cube; and f) a notebook. Patients will have the option of contacting a MD though WhatsApp regarding questions related to their treatment. After completing baseline a questionnaire, patients with a score of 2 for barriers that might affect their ART adherence will be assigned a coach. The coach will have 7 one-on-one sessions with the patient in a period of 4 months in order to catalyze ART adherence. MSM living with HIV who have been taking ART for \>3 years will provide a one-time one-on-one peer support session

Behavioral: FUERTES

Interventions

FUERTES BEHAVIORAL

The intervention focuses on antiretroviral therapy habit-formation among MSM living with HIV

Also known as: STRONG

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Being a woman, a transgender man or transgender woman is an exclusion criteria for the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be MSM
• be 18 or more years of age
• treatment initiation between one day and one month ago, with expected continuation of treatment for the next ten months
• literate Spanish
• living in the metropolitan area of Guadalajara or Villahermosa
• willing and able to provide written informed consent and contact information ( a phone number).

You may not qualify if:

• cisgender or transgender woman
• transvestite, transgender or transsexual man
• living with AIDS and taking four or more medicines for opportunistic infections
• diagnosis of any neurologic, memory, sight or any other clinical illness that would prevent them answering the questionnaires
• kidney disease with creatinine clearance below 50
• presenting with acute liver failure or chronic liver failure
• negative perception towards ART (ART as pharmaceutical lie, more harmful than beneficial)
• the presence of a mental illness that requires a care assistant/guardian or treatment with psychiatric medication (e.g. schizophrenia, bipolar disorder, etc.)
• participating in another research study to improve ART adherence
• living on the street
• unwilling to provide written informed consent or contact information
• \) refusal to participate.

Sponsors & Collaborators

• Instituto Nacional de Salud Publica, Mexico: lead
• Hospital Civil Juan I. Menchaca: collaborator
• Hospital General de Occidente: collaborator
• CAPASITS Villahermosa: collaborator

Study Sites (3)

Hospital Civil Nuevo Dr. Juan I. Menchaca

Guadalajara, Jalisco, 44340, Mexico

Location

Hospital General de Occidente

Guadalajara, Jalisco, 45170, Mexico

Location

CAPASITS Villahermosa

Villahermosa, Tabasco, 86060, Mexico

Location

Related Publications (1)

• Andrade-Romo Z, La Hera-Fuentes G, Ochoa-Sanchez LE, Chavira-Razo L, Aramburo-Muro T, Castro-Leon L, Amaya-Tapia G, Andrade-Perez JS, Bautista-Arredondo S. 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. AIDS Care. 2024 Jun;36(6):816-831. doi: 10.1080/09540121.2023.2299322. Epub 2024 Feb 29.

  PMID: 38422450 DERIVED

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Study Officials

• Sergio Bautista-Arredondo, MSc

  National Institute of public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The recruiting staff will not have access to the results of randomization prior to recruiting the participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Health Economics and Health Systems Innovations

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 25, 2018
• Study Start: December 5, 2017
• Primary Completion: November 20, 2019
• Study Completion: December 1, 2024
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The data generated will be available publicly in Dataverse starting January 2020
• Access Criteria: To be defined after data collection ends

Locations

ME (3)