AIDSCAPSNCT01058694
The Impact of Short Message Services (SMS) on ARV Adherence in Western Kenya
A study testing Short Message Services to Support ARV therapy adherence in people with AIDS and Antiretroviral Therapy, run by Georgetown University at 1 site in Kenya.
Trial summary
The purpose of proposed research is to implement a randomized study that will allow us to understand and address a number of key barriers to patient adherence as well as study the effects of better adherence on health and socio-economic outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS, Antiretroviral Therapy, Medication Adherence
- What is being tested?
- Short Message Services to Support ARV therapy adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteKenya
- Study dates
- Jun 2007to Jul 2009
- 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
- Patients who had been on ARV therapy at the Chulaimbo Rural Health Center for a maximum of three months and providing consent to participate in the study.
Who cannot join
- Patients who had been on ARV therapy for more than 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence to ARV Treatment and Its Effects on Medium Run Socio-Economic Outcomes: Evidence From Western Kenya
The purpose of proposed research is to implement a randomized study that will allow us to understand and address a number of key barriers to patient adherence as well as study the effects of better adherence on health and socio-economic outcomes.
Read the detailed description
Several studies have shown that proper adherence to treatment regimens is essential for the effectiveness of ARV therapy (e.g Wools-Kaloustian et al. 2006). There is also evidence in that in some treatment programs in Africa, adherence rates are not always high (Gill et al. 2005). Even in settings where adherence levels are found to be high, numerous factors have been identified as being relevant, although the causal effects are unknown (Castro, 2006). As ARV treatment programs are scaled up in Africa, it is essential to understand the socio-economic determinants of adherence to ARV treatment, as well as the impact of interventions to support high levels of adherence. A secondary objective of this study is to understand the socio-economic impacts of higher adherence.
- Conditions
- AIDS, Antiretroviral Therapy, Medication Adherence, HIV Infections
- Being tested
- Short Message Services to Support ARV therapy adherence
- Keywords
- Mobile phones,, Medication Adherence, Micro-Electrical-Mechanical Systems, HIV Infections
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Message Services to Support ARV therapy adherenceBehavioural
Short message services were sent to randomly selected consenting subjects on ARV therapy. The frequency and content of the message is varied in a factorial design.
| Study group | Role | What they receive |
|---|---|---|
| Weekly SMS, brief message | Experimental | Weekly SMS received on Monday at 12 noon Receives: Behavioral: Short Message Services to Support ARV therapy adherence |
| Control Group | Active comparator | Receives a phone, but no messages. Receives: Behavioral: Short Message Services to Support ARV therapy adherence |
| Daily SMS, Brief message | Experimental | Receive daily brief message at 12 noon: "This is your reminder" Receives: Behavioral: Short Message Services to Support ARV therapy adherence |
| Daily SMS, Long Message | Experimental | Receive a daily long message at 12 noon: "This is your reminder + encouragement" Receives: Behavioral: Short Message Services to Support ARV therapy adherence |
| Weekly SMS, Long Message | Experimental | Weekly message sent at 12 noon on Mondays: "This is your reminder + encouragement" Receives: Behavioral: Short Message Services to Support ARV therapy adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEMS Adherence
Measured: 12 months follow up
Secondary outcomes (1)
Frequency/incidence of ARV treatment interruptions
Measured: 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startJun 2007
- Primary completionDec 2008
- Study completionJul 2009
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 AIDSStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi Univeristy, World Bank, Indiana University, Harvard University, Columbia University, University of California, San Diego, University of North Carolina
- Investigators
- John Sidle, MD, Principal investigator, Indiana UniversityDuncan Ngare, Phd, Principal investigator, Moi UniversityHarsha Thirumurthy, Phd, Principal investigator, University of North CarolinaMarkus Goldstein, Phd, Principal investigator, World BankJoshua Graff-Zivin, Phd, Principal investigator, University of California, San DiegoDamien de Walque, Phd, Principal investigator, World BankCristian Pop-Eleches, Phd, Principal investigator, Columbia UniversityDavid Bangsberg, MD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058694
- Sponsor's protocol ID
- 2008-005
- Acronym
- CAPS
- Status last verified
- Jan 2010
- First submitted
- 27 Jan 2010
- Last updated
- 29 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Pop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, de Walque D, MacKeen L, Haberer J, Kimaiyo S, Sidle J, Ngare D, Bangsberg DR. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS. 2011 Mar 27;25(6):825-34. doi: 10.1097/QAD.0b013e32834380c1.
PubMed 21252632
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to ARV Treatment and Its Effects on Medium Run Socio-Economic Outcomes: Evidence From Western Kenya
- ClinicalTrials.gov ID
- NCT01058694
- Acronym / sponsor ID
- CAPS / 2008-005
- Conditions
- AIDS, Antiretroviral Therapy, Medication Adherence, HIV Infections
- Keywords
- Mobile phones,, Medication Adherence, Micro-Electrical-Mechanical Systems, HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Moi Univeristy, World Bank, Indiana University, Harvard University, Columbia University, University of California, San Diego, University of North Carolina
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Jan 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 purpose of proposed research is to implement a randomized study that will allow us to understand and address a number of key barriers to patient adherence as well as study the effects of better adherence on health and socio-economic outcomes.
Detailed description
Several studies have shown that proper adherence to treatment regimens is essential for the effectiveness of ARV therapy (e.g Wools-Kaloustian et al. 2006). There is also evidence in that in some treatment programs in Africa, adherence rates are not always high (Gill et al. 2005). Even in settings where adherence levels are found to be high, numerous factors have been identified as being relevant, although the causal effects are unknown (Castro, 2006). As ARV treatment programs are scaled up in Africa, it is essential to understand the socio-economic determinants of adherence to ARV treatment, as well as the impact of interventions to support high levels of adherence. A secondary objective of this study is to understand the socio-economic impacts of higher adherence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Weekly SMS, brief message | Experimental | Behavioral: Short Message Services to Support ARV therapy adherenceWeekly SMS received on Monday at 12 noon |
| Control Group | Active comparator | Behavioral: Short Message Services to Support ARV therapy adherenceReceives a phone, but no messages. |
| Daily SMS, Brief message | Experimental | Behavioral: Short Message Services to Support ARV therapy adherenceReceive daily brief message at 12 noon: "This is your reminder" |
| Daily SMS, Long Message | Experimental | Behavioral: Short Message Services to Support ARV therapy adherenceReceive a daily long message at 12 noon: "This is your reminder + encouragement" |
| Weekly SMS, Long Message | Experimental | Behavioral: Short Message Services to Support ARV therapy adherenceWeekly message sent at 12 noon on Mondays: "This is your reminder + encouragement" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had been on ARV therapy at the Chulaimbo Rural Health Center for a maximum of three months and providing consent to participate in the study.
Key exclusion criteria (1 listed)
- Patients who had been on ARV therapy for more than 3 months.
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 |
|---|---|---|
| Short Message Services to Support ARV therapy adherenceShort message services were sent to randomly selected consenting subjects on ARV therapy. The frequency and content of the message is varied in a factorial design. | Behavioural | Control Group, Daily SMS, Brief message, Daily SMS, Long Message, Weekly SMS, Long Message, Weekly SMS, brief message |
Primary outcome
MEMS Adherence
Time frame: 12 months follow up
1 secondary outcome
Frequency/incidence of ARV treatment interruptions
Time frame: 12 months follow up
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 29 Jan 2010.
- Derived from this study: PubMed 21252632Pop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, de Walque D, MacKeen L, Haberer J, Kimaiyo S, Sidle J, Ngare D, Bangsberg DR. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS. 2011 Mar 27;25(6):825-34. doi: 10.1097/QAD.0b013e32834380c1.
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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.
John Sidle, MD principal investigator
Indiana University
Duncan Ngare, Phd principal investigator
Moi University
Harsha Thirumurthy, Phd principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Message Services to Support ARV therapy adherence in people with AIDS and Antiretroviral Therapy, run by Georgetown University at 1 site in Kenya.
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 1 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 29 Jan 2010. 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 Kenya. 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?
MEMS Adherence (time frame: 12 months follow up). 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 NCT01058694, 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 29 Jan 2010.