A Habit-formation and Gamification Intervention to Improve ART Adherence Among MSM HIV Patients in Mexico (FUERTES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03410680|
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : January 25, 2018
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||184 participants|
|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.|
|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|
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
The intervention focuses on antiretroviral therapy habit-formation among MSM living with HIV
Other Name: STRONG
- 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).
- 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.
- 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.
- 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.
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
|Contact: Zafiro Andrade, MScfirstname.lastname@example.org|
|Contact: Sergio Bautista-Arredondo, MScemail@example.com|
|Hospital Civil Nuevo Dr. Juan I. Menchaca||Recruiting|
|Guadalajara, Jalisco, Mexico, 44340|
|Contact: Jorge S Andrade, MS +523336189362 ext 1410 firstname.lastname@example.org|
|Contact: Liliana Reynoso, MD +5213310423859 email@example.com|
|Principal Investigator: Jorge S Andrade, MS|
|Hospital General de Occidente||Recruiting|
|Guadalajara, Jalisco, Mexico, 45170|
|Contact: Gerardo Amaya, MD +5233 3030 6300 firstname.lastname@example.org|
|Contact: Elizabeth López, MD +5213313408489 email@example.com|
|Principal Investigator: Gerardo Amaya, MD|
|Principal Investigator:||Sergio Bautista-Arredondo, MSc||National Institute of public Health|