HIVNCT01760759
Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
A study testing cell phone reminders and contingency management for adherence in people with HIV, run by UConn Health at 2 sites in United States.
Trial summary
In this study, investigators propose to randomize 165 human immunodeficiency virus positive patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence reminders and contingency management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- cell phone reminders and contingency management for adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2012to Apr 2019
- 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
- age > 18 years
- initiating or on an antiretroviral therapy regimen and have a viral load >200 copies/mL in the past 6 months
- one or more risk factors for poor adherence
- English speaking
- willing to use a cell phone to receive reminders and record medication ingestion for up to 16 weeks
- able to read at 5th grade level and pass a brief quiz related to understanding the informed consent form
Who cannot join
- living in an environment or has a visiting nurse that dispenses antiretroviral therapy medication
- participating in another antiretroviral therapy adherence study
- uncontrolled psychiatric disorders
- significant cognitive impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Connecticut Health Center
Farmington, Connecticut, 06030-3944
Nathan Smith Clinic, Yale-New Haven Hospital
New Haven, Connecticut, 06520
About this study
In this study, investigators propose to randomize 165 human immunodeficiency virus positive patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence reminders and contingency management. In this latter condition, patients will earn reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy medication ingestion. Primary outcomes will include viral loads and self-report measures of adherence, and effects will be evaluated both during the treatment period and throughout a one-year follow-up. Investigators hypothesize that the cell phone reminder condition will improve adherence relative to standard care, and the cell phone reminder plus contingency management condition will have the best outcomes. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve initial adherence to antiretroviral therapy, thereby reducing the spread of drug resistant human immunodeficiency virus strains to the community.
- Conditions
- HIV
- Being tested
- cell phone reminders, contingency management for adherence
- Keywords
- HIV, Antiretroviral therapy adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell phone remindersBehavioural
Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
contingency management for adherenceBehavioural
Patients will receive reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients receive usual care from their medical providers. |
| Usual care plus cell phone reminders | Experimental | Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing. Receives: Behavioral: cell phone reminders |
| Usual care, reminders & contingency management for adherence | Experimental | Patients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time. Receives: Behavioral: cell phone reminders; Behavioral: contingency management for adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in copies of human immunodeficiency virus per milliliter
Measured: Week 48
self-report of medication adherence
Measured: baseline
self-report of medication adherence
Measured: Week 8
self-report of medication adherence
Measured: Week 16
self-report of medication adherence
Measured: Week 24
self-report of medication adherence
Measured: Week 36
self-report of medication adherence
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2019
- Study completionApr 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Carla Rash, UConn Health
- Investigators
- Carla Rash, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760759
- Sponsor's protocol ID
- 12-205O-2
- Other IDs
- R01HD075630
- Status last verified
- Sep 2019
- First submitted
- 21 Aug 2012
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus
- ClinicalTrials.gov ID
- NCT01760759
- Acronym / sponsor ID
- 12-205O-2
- Conditions
- HIV
- Keywords
- HIV, Antiretroviral therapy adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2012 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 4 Jan 2013 (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.
In this study, investigators propose to randomize 165 human immunodeficiency virus positive patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence reminders and contingency management. In this latter condition, patients will earn reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy medication ingestion. Primary outcomes will include viral loads and self-report measures of adherence, and effects will be evaluated both during the treatment period and throughout a one-year follow-up. Investigators hypothesize that the cell phone reminder condition will improve adherence relative to standard care, and the cell phone reminder plus contingency management condition will have the best outcomes. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve initial adherence to antiretroviral therapy, thereby reducing the spread of drug resistant human immunodeficiency virus strains to the community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients receive usual care from their medical providers. |
| Usual care plus cell phone reminders | Experimental | Behavioral: cell phone remindersPatients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing. |
| Usual care, reminders & contingency management for adherence | Experimental | Behavioral: cell phone reminders, Behavioral: contingency management for adherencePatients receive reminders and reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age > 18 years
- initiating or on an antiretroviral therapy regimen and have a viral load >200 copies/mL in the past 6 months
- one or more risk factors for poor adherence
- English speaking
- willing to use a cell phone to receive reminders and record medication ingestion for up to 16 weeks
Key exclusion criteria (4 listed)
- living in an environment or has a visiting nurse that dispenses antiretroviral therapy medication
- participating in another antiretroviral therapy adherence study
- uncontrolled psychiatric disorders
- significant cognitive impairment
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 remindersPatients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing. | Behavioural | Usual care plus cell phone reminders, Usual care, reminders & contingency management for adherence |
| contingency management for adherencePatients will receive reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time. | Behavioural | Usual care, reminders & contingency management for adherence |
Primary outcome
change in copies of human immunodeficiency virus per milliliter
Time frame: Week 48
self-report of medication adherence
Time frame: baseline
self-report of medication adherence
Time frame: Week 8
self-report of medication adherence
Time frame: Week 16
self-report of medication adherence
Time frame: Week 24
self-report of medication adherence
Time frame: Week 36
self-report of medication adherence
Time frame: Week 48
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 13 Sep 2019.
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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.
Carla Rash, Ph.D. principal investigator
UConn Health
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 reminders and contingency management for adherence in people with HIV, run by UConn Health at 2 sites in United States.
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 4 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 13 Sep 2019. 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 United States. 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?
change in copies of human immunodeficiency virus per milliliter (time frame: Week 48). The study lists 7 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 13 Sep 2019.