HIVCell-POSNCT01118767
Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru
A study testing Cell phone intervention in people with HIV and Adherence, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.
Trial summary
The investigators propose to develop and evaluate a computer-based intervention using cell phones to enhance adherence to antiretroviral treatment (ART) and support of HIV transmission risk-reduction among adult HIV-positive patients in Peru. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Adherence, Sexual Behavior
- What is being tested?
- Cell phone intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesPeru
- Study dates
- 1 May 2010to 10 Dec 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-positive healthy male or female aged greater than or equal to 18
- Currently on ART
- Patients with a mobile phone for their personal use (not shared)
- Patients who know how to retrieve read text messages on their mobile phone
- Signed and dated written informed consent prior to admission to the study
Who cannot join
- Patients whose clinical condition might have interfered with the study (e.g., deafness, serious mental illness, mental retardation)
- Patients unable to give their informed consent.
Trial locations and contacts
2 sites in 1 country.
About this study
The investigators propose to develop and evaluate a computer-based intervention using cell phones to enhance adherence to antiretroviral treatment (ART) and support of HIV transmission risk-reduction among adult HIV-positive patients in Peru.
Read the detailed description
Adherence to ART is critical for treatment success at the individual level and to avoid the onset of resistant strains of HIV. In Peru, where ART has recently been introduced, adherence to HIV treatment has not yet been addressed properly. Innovative approaches using information technologies such as cell phones are needed to increase adherence to ART for people with HIV/AIDS. The specific aims of the study are to: 1) Conduct formative research to assess culturally-specific behavioral messages to be included in the computer-based system; 2) Develop and test an interactive computer-based system using cell phones to enhance adherence to ART and to deliver HIV transmission risk reduction messages; 3) Evaluate the impact of the system on antiretroviral adherence and sexual risk behaviors.
- Conditions
- HIV, Adherence, Sexual Behavior, HIV Infections
- Being tested
- Cell phone intervention
- Keywords
- Adherence, Appointment, Cell Phone, Cellular Phone, Clinic, Computers, Controlled Clinical Trials, Randomized, HIV/AIDS, Health Informatics, Health behavior, Information Technology, Internet, Intervention, Medication, Patient Satisfaction, Patient Self-Report, Patients, Peru, Phone, Public Health
- Medical subject headings
- Sexual Behavior, HIV Infections, Acquired Immunodeficiency Syndrome, Health Behavior, Patient Satisfaction, Sexually Transmitted Diseases, Unsafe Sex, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell phone interventionOther
Participant receives short text messages, including: antiretroviral reminders, clinic appointment reminders, and preventive/educational messages
| Study group | Role | What they receive |
|---|---|---|
| Cell phone intervention | Experimental | Participant receives short text messages Receives: Other: Cell phone intervention |
| Standard of care | No intervention | Participant receives standard of care support but not short text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported medication adherence
Measured: 12 months
HIV-1 viral load
Measured: 12 months
Secondary outcomes (2)
CD4
Measured: 12 months
Self-reported HIV transmission risk behaviors
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study start1 May 2010
- Primary completion1 Dec 2011
- Study completion10 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Walter Curioso Vilchez, Universidad Peruana Cayetano Heredia
- Investigators
- Walter H Curioso, MD, MPH, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118767
- Sponsor's protocol ID
- R01TW007896
- Other IDs
- R01TW007896
- Acronym
- Cell-POS
- Status last verified
- Nov 2021
- First submitted
- 6 May 2010
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Computer-Based System Using Cell Phones for HIV People in Peru
- ClinicalTrials.gov ID
- NCT01118767
- Acronym / sponsor ID
- Cell-POS / R01TW007896
- Conditions
- HIV, Adherence, Sexual Behavior, HIV Infections
- Keywords
- Adherence, Appointment, Cell Phone, Cellular Phone, Clinic, Computers, Controlled Clinical Trials, Randomized, HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 1 May 2010 (actual)
- Primary completion
- 1 Dec 2011 (actual)
- Study completion
- 10 Dec 2011 (actual)
- First posted
- 7 May 2010 (estimated)
- 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.
The investigators propose to develop and evaluate a computer-based intervention using cell phones to enhance adherence to antiretroviral treatment (ART) and support of HIV transmission risk-reduction among adult HIV-positive patients in Peru.
Detailed description
Adherence to ART is critical for treatment success at the individual level and to avoid the onset of resistant strains of HIV. In Peru, where ART has recently been introduced, adherence to HIV treatment has not yet been addressed properly. Innovative approaches using information technologies such as cell phones are needed to increase adherence to ART for people with HIV/AIDS. The specific aims of the study are to: 1) Conduct formative research to assess culturally-specific behavioral messages to be included in the computer-based system; 2) Develop and test an interactive computer-based system using cell phones to enhance adherence to ART and to deliver HIV transmission risk reduction messages; 3) Evaluate the impact of the system on antiretroviral adherence and sexual risk behaviors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell phone intervention | Experimental | Other: Cell phone interventionParticipant receives short text messages |
| Standard of care | No intervention | –Participant receives standard of care support but not short text messages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-positive healthy male or female aged greater than or equal to 18
- Currently on ART
- Patients with a mobile phone for their personal use (not shared)
- Patients who know how to retrieve read text messages on their mobile phone
- Signed and dated written informed consent prior to admission to the study
Key exclusion criteria (2 listed)
- Patients whose clinical condition might have interfered with the study (e.g., deafness, serious mental illness, mental retardation)
- Patients unable to give their informed consent.
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 |
|---|---|---|
| Cell phone interventionParticipant receives short text messages, including: antiretroviral reminders, clinic appointment reminders, and preventive/educational messages | Other | Cell phone intervention |
Primary outcome
Self-reported medication adherence
Time frame: 12 months
HIV-1 viral load
Time frame: 12 months
2 secondary outcomes
CD4
Time frame: 12 months
Self-reported HIV transmission risk behaviors
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
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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.
Walter H Curioso, MD, MPH principal investigator
Universidad Peruana Cayetano Heredia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell phone intervention in people with HIV and Adherence, run by Universidad Peruana Cayetano Heredia at 2 sites in Peru.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Peru. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-reported medication adherence (time frame: 12 months). 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?
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 22 Nov 2021.