HIV InfectionNCT02301507
Study of Cell Phone SMS to Improve Adherence to ART in HIV Positive Young Women
A study testing cell phone SMS text messaging in people with HIV Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
There has been increasing use of technology in delivery of healthcare and increasing use of cellular phone and text messaging services to help with various healthcare related issues including but not limited to medication adherence and clinic attendance. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- HIV Infection
- What is being tested?
- cell phone SMS text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jul 2016
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- HIV-infected women who have been newly diagnosed within the past 1 year or who are just entering into care at Thomas Street Health Center.
- Subjects must be 18 years or older.
- Subjects must have cell phones with texting capability.
- Ability to speak, read, or understand English or Spanish.
- Must be willing and able to respond to text messages.
Who cannot join
- 1. Women who are unable to speak, read, or understand English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Texting Intervention to Improve Adherence to Antiretroviral Therapy (ART) in Young Women Infected With Human Immunodeficiency Virus (HIV)
There has been increasing use of technology in delivery of healthcare and increasing use of cellular phone and text messaging services to help with various healthcare related issues including but not limited to medication adherence and clinic attendance. Mobile phones technology has been used for healthcare delivery and prevention strategies such as smoking cessation. In the present era, cell phones have become part of daily life for most people even among those in lower economic groups. There have also been several studies looking at cell phone text messaging services to improve adherence to ART among HIV infected subjects but no studies have so far been done in HIV infected young women to help retention and adherence to care. The overall goal of this study is to evaluation of the impact of texting intervention to improve adherence to care and treatment in HIV infected young women.
Study Hypothesis:
Text message intervention will improve adherence to ART in HIV infected young women.
- Conditions
- HIV Infection
- Being tested
- cell phone SMS text messaging
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell phone SMS text messagingBehavioural
This study will utilize mobile texting services to send text messages to enrolled subjects on a weekly basis. The text would convey messages that promote better awareness and knowledge on HIV and its treatment, reminders for medication adherence and clinic appointments. The text content would also be customized based on individual subject requirements. English will be used in texting. We would also assess the subjects for traditional demographic items (e.g., age, marital status, education, number/age of other children, employment, and religion), and potential environmental barriers (e.g., transportation and childcare).
| Study group | Role | What they receive |
|---|---|---|
| SMS (texting) Arm | Experimental | texts received Receives: Behavioral: cell phone SMS text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve adherence to care and treatment in HIV infected young women. The outcome measure will be assessed by capturing kept medical appointments.
Measured: 6 months
Secondary outcomes (1)
assess improvements in stigma and depression in HIV infected women. The outcome measure will be assessed by questionaires.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301507
- Sponsor's protocol ID
- HSC-MS-14-0692
- Status last verified
- May 2017
- First submitted
- 18 Nov 2014
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Texting Intervention to Improve Adherence to Antiretroviral Therapy (ART) in Young Women Infected With Human Immunodeficiency Virus (HIV)
- ClinicalTrials.gov ID
- NCT02301507
- Acronym / sponsor ID
- HSC-MS-14-0692
- Conditions
- HIV Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Nov 2014 (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.
There has been increasing use of technology in delivery of healthcare and increasing use of cellular phone and text messaging services to help with various healthcare related issues including but not limited to medication adherence and clinic attendance. Mobile phones technology has been used for healthcare delivery and prevention strategies such as smoking cessation. In the present era, cell phones have become part of daily life for most people even among those in lower economic groups. There have also been several studies looking at cell phone text messaging services to improve adherence to ART among HIV infected subjects but no studies have so far been done in HIV infected young women to help retention and adherence to care. The overall goal of this study is to evaluation of the impact of texting intervention to improve adherence to care and treatment in HIV infected young women.
Study Hypothesis:
Text message intervention will improve adherence to ART in HIV infected young women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMS (texting) Arm | Experimental | Behavioral: cell phone SMS text messagingtexts received |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- HIV-infected women who have been newly diagnosed within the past 1 year or who are just entering into care at Thomas Street Health Center.
- Subjects must be 18 years or older.
- Subjects must have cell phones with texting capability.
- Ability to speak, read, or understand English or Spanish.
- Must be willing and able to respond to text messages.
Key exclusion criteria (1 listed)
- 1. Women who are unable to speak, read, or understand English or Spanish
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 SMS text messagingThis study will utilize mobile texting services to send text messages to enrolled subjects on a weekly basis. The text would convey messages that promote better awareness and knowledge on HIV and its treatment, reminders for medication adherence and clinic appointments. The text content would also be customized based on individual subject requirements. English will be used in texting. We would also assess the subjects for traditional demographic items (e.g., age, marital status, education, number/age of other children, employment, and religion), and potential environmental barriers (e.g., transportation and childcare). | Behavioural | SMS (texting) Arm |
Primary outcome
Improve adherence to care and treatment in HIV infected young women. The outcome measure will be assessed by capturing kept medical appointments.
Time frame: 6 months
1 secondary outcome
assess improvements in stigma and depression in HIV infected women. The outcome measure will be assessed by questionaires.
Time frame: 3 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 23 May 2017.
Related trials for HIV Infection
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cell phone SMS text messaging in people with HIV Infection, run by The University of Texas Health Science Center, Houston at 1 site 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 5 inclusion and 1 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Improve adherence to care and treatment in HIV infected young women. The outcome measure will be assessed by capturing kept medical appointments. (time frame: 6 months). 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 23 May 2017.