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

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ClinicalTrials.gov Identifier: NCT03410680
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
Hospital Civil Juan I. Menchaca
Hospital General de Occidente
Information provided by (Responsible Party):
Sergio Bautista Arredondo, Instituto Nacional de Salud Publica, Mexico

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.


Condition or disease Intervention/treatment Phase
HIV Behavioral: FUERTES Not Applicable

Detailed Description:

FUERTES is 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.

The first component includes providing each participant in the intervention arm with a habit-formation kit, which will include: 1) an information and habit-formation tool that can be accessed through a web platform, a mobile app and a booklet 2) a pocket pill-case; 3) a weekly pill organizer; 4) a water bottle containing a hidden pill case; 5) a fidget cube; and 6) a notebook and pen. Patients will also have access to a phone number to solve questions regarding HIV and ART with a medical doctor.

The second component includes providing social support to patients with high level of barriers that might influence the adherence to ART, through two mechanisms. Firstly, participants will receive professional psychologists will act as habit-formation coaches and will provide emotional support, sex education and referral to relevant health services. Secondly, they will receive one-on-one habit-formation support from MSM living with HIV who have been taking ART for several years, with the objective of reducing self-stigma and providing experience and reassurance that living a full and healthy life with HIV is possible.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: The recruiting staff will not have access to the results of randomization prior to recruiting the participant.
Primary Purpose: Treatment
Official Title: Evaluation of a Habit-formation and Gamification Intervention to Improve Adherence to Antiretroviral Therapy Among MSM Who Are New HIV Patients in Mexico
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : October 4, 2019
Estimated Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Control arm
Patients will receive the standard of care at the clinic. Questionnaires will be applied 4 times in a period of 10 months
Experimental: Intervention arm

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
The intervention focuses on antiretroviral therapy habit-formation among MSM living with HIV
Other Name: STRONG




Primary Outcome Measures :
  1. Change in HIV viral load [ Time Frame: Baseline (week 0), 1 month, 4 months, 10 months ]
    Change from Baseline HIV viral load measured through medical chart abstraction (suppressed HIV viral load: ≤ 40 copies/mL).

  2. Change in CD4 cell count [ Time Frame: Baseline (week 0), 1 month, 4 months, 10 months ]
    Change from Baseline CD4 cell count measured through medical chart abstraction.


Secondary Outcome Measures :
  1. Change in ART adherence status [ Time Frame: Baseline (1 month), 4 months, 10 months ]

    ART adherence will be assessed by different well-validated methods. In this study, ART adherence will be measured using medication possession ratio which measures participants' medication adherence using pharmacy refill information. We will also use a questionnaire based on the "AIDS Clinical Trials Group (ACTG) adherence follow up questionnaire", adapted after the pilot phase. We will administer this questionnaire through self-interview survey in a phablet. We will also use a 30 day recall question.

    While higher values indicate better levels of adherence, patients with adherence levels of 90% and above are regarded as ART-adherent while those with values less than 90% are not adherent to ART medications.


  2. Change in antiretroviral therapy habit-strength [ Time Frame: Baseline (1 month), 4 months, 10 months ]
    We will assess patient's habit strength using a self-report habit index questionnaire. We will administer this questionnaire through a self-interview survey in a phablet. We will average the scale scores. A high mean score will indicate greater habit strength.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Being a woman, a transgender man or transgender woman is an exclusion criteria for the study
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. be MSM
  2. be 18 or more years of age
  3. be between one day and one month receiving ART at the Hospital Civil Nuevo or the Hospital General de Occidente
  4. know how to read and write in Spanish
  5. live in the metropolitan area of Guadalajara
  6. be willing and able to give written informed consent and their phone number to be contacted.

Exclusion criteria:

  1. are a cisgender or transgender woman
  2. are a transvestite, transgender or transsexual man
  3. are living with AIDS and taking four or more medicines for opportunistic infections
  4. have a neurologic, memory, sight or any other clinical affection that prevented from answering the questionnaires
  5. have kidney disease with creatinine clearance below 50
  6. present with liver failure
  7. present with a mental illness that requires a care assistant/guardian and/or psychiatric medication (e.g. schizophrenia, bipolar disorder, etc.)
  8. are a participant in another research study to improve ART adherence
  9. are unwilling to give written informed consent or his phone number to be contacted
  10. do not agree to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410680


Contacts
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Contact: Zafiro Andrade, MSc +5217771031042 ciss22@insp.mx
Contact: Sergio Bautista-Arredondo, MSc +527773293068 sbautista@insp.mx

Locations
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Mexico
Hospital Civil Nuevo Dr. Juan I. Menchaca Recruiting
Guadalajara, Jalisco, Mexico, 44340
Contact: Jorge S Andrade, MS    +523336189362 ext 1410    jorgeandradep@gmail.com   
Contact: Liliana Reynoso, MD    +5213310423859    fuertes.civilnuevo@gmail.com   
Principal Investigator: Jorge S Andrade, MS         
Hospital General de Occidente Recruiting
Guadalajara, Jalisco, Mexico, 45170
Contact: Gerardo Amaya, MD    +5233 3030 6300    gamaya@cencar.udg.mx   
Contact: Elizabeth López, MD    +5213313408489    fuertes.zoquipan@gmail.com   
Principal Investigator: Gerardo Amaya, MD         
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Hospital Civil Juan I. Menchaca
Hospital General de Occidente
Investigators
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Principal Investigator: Sergio Bautista-Arredondo, MSc National Institute of public Health

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Responsible Party: Sergio Bautista Arredondo, Director of Health Economics and Health Systems Innovations, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier: NCT03410680     History of Changes
Other Study ID Numbers: 2014-1-233508
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sergio Bautista Arredondo, Instituto Nacional de Salud Publica, Mexico:
Antiretroviral Therapy
Adherence
HIV
Men who have sex with men
Sexual minorities
habit-formation
gamification

Additional relevant MeSH terms:
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Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents