HIVFUERTESNCT03410680
A Habit-formation and Gamification Intervention to Improve ART Adherence Among MSM HIV Patients in Mexico
A study testing FUERTES in people with HIV, run by Instituto Nacional de Salud Publica, Mexico at 3 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV
- What is being tested?
- FUERTES
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 3 sitesMexico
- Study dates
- 5 Dec 2017to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 12Show fewer
- 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
- 11) refusal to participate.
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites
Hospital Civil Nuevo Dr. Juan I. Menchaca
Guadalajara, Jalisco, 44340
Hospital General de Occidente
Guadalajara, Jalisco, 45170
CAPASITS Villahermosa
Villahermosa, Tabasco, 86060
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- HIV
- Being tested
- FUERTES
- Keywords
- Antiretroviral Therapy, Adherence, HIV, Men who have sex with men, Sexual minorities, habit-formation, gamification
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FUERTESBehavioural
Also called STRONG
The intervention focuses on antiretroviral therapy habit-formation among MSM living with HIV
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: FUERTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HIV viral load
Change from Baseline HIV viral load measured through medical chart abstraction (suppressed HIV viral load: ≤ 40 copies/mL).
Measured: 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.
Measured: Baseline (week 0), 1 month, 4 months, 10 months, 3 years
Secondary outcomes (2)
Change in ART adherence status
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.
Measured: Baseline (1 month), 4 months, 10 months
Change in antiretroviral therapy habit-strength
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.
Measured: Baseline (1 month), 4 months, 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start5 Dec 2017
- Primary completion20 Nov 2019
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Civil Juan I. Menchaca, Hospital General de Occidente, CAPASITS Villahermosa
- Responsible party
- Principal investigator, Sergio Bautista Arredondo, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Sergio Bautista-Arredondo, MSc, Principal investigator, National Institute of public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410680
- Sponsor's protocol ID
- 2014-1-233508
- Acronym
- FUERTES
- Status last verified
- Sep 2021
- First submitted
- 8 Jan 2018
- Last updated
- 9 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data generated will be available publicly in 2020 in Dataverse, and it could be made available from the corresponding author upon reasonable request, for academic purposes.
Publications
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.
PubMed 38422450
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03410680
- Acronym / sponsor ID
- FUERTES / 2014-1-233508
- Conditions
- HIV
- Keywords
- Antiretroviral Therapy, Adherence, HIV, Men who have sex with men, Sexual minorities, habit-formation, gamification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- Hospital Civil Juan I. Menchaca, Hospital General de Occidente, CAPASITS Villahermosa
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: FUERTESEach 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FUERTESAlso: STRONGThe intervention focuses on antiretroviral therapy habit-formation among MSM living with HIV | Behavioural | Intervention arm |
Primary outcome
Change in HIV viral load
Time frame: Baseline (week 0), 1 month, 4 months, 10 months, 3 years
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, 3 years
Change from Baseline CD4 cell count measured through medical chart abstraction.
2 secondary outcomes
Change in ART adherence status
Time frame: Baseline (1 month), 4 months, 10 months
Change in antiretroviral therapy habit-strength
Time frame: Baseline (1 month), 4 months, 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Derived from this study: PubMed 38422450Andrade-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.
- Individual participant dataSharing planned: Yes. The data generated will be available publicly in 2020 in Dataverse, and it could be made available from the corresponding author upon reasonable request, for academic purposes.
Related trials for HIV
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
RecruitingObservational study
Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV
HIV, Immunodeficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Bautista-Arredondo, MSc principal investigator
National Institute of public Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FUERTES in people with HIV, run by Instituto Nacional de Salud Publica, Mexico at 3 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HIV viral load (time frame: Baseline (week 0), 1 month, 4 months, 10 months, 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03410680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021; AzTrials last refreshed its copy on 1 Nov 2026.