Clinical trial NCT03410680: A Habit-formation and Gamification Intervention to Improve ART Adherence Among MSM HIV Patients in Mexico
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: Antiretroviral Therapy
Adherence
HIV
Men who have sex with men
Sexual minorities
habit-formation
gamification
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
Collaborators: name: Hospital Civil Juan I. Menchaca
name: Hospital General de Occidente
name: CAPASITS Villahermosa
First posted: 2018-01-25
Enrollment: 184
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

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

11) refusal to participate.

Primary outcomes:
measure: Change in HIV viral load
timeFrame: Baseline (week 0), 1 month, 4 months, 10 months, 3 years
measure: Change in CD4 cell count
timeFrame: Baseline (week 0), 1 month, 4 months, 10 months, 3 years
Secondary outcomes:
measure: Change in ART adherence status
timeFrame: Baseline (1 month), 4 months, 10 months
measure: Change in antiretroviral therapy habit-strength
timeFrame: Baseline (1 month), 4 months, 10 months
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil Nuevo Dr. Juan I. Menchaca
state: Jalisco
city: Guadalajara
country: Mexico
facility: Hospital General de Occidente
state: Jalisco
city: Villahermosa
country: Mexico
facility: CAPASITS Villahermosa
state: Tabasco
Study officials:
affiliation: National Institute of public Health
name: Sergio Bautista-Arredondo, MSc
role: PRINCIPAL_INVESTIGATOR
References: