HIV InfectionsNCT01001741
Pilot Study of Text Message Reminders to Improve HIV Medication Adherence in Botswana
A study testing Cell phone text message in people with HIV Infections, run by University of Pennsylvania at 1 site in Botswana.
Trial summary
While medication adherence is critical to successful treatment of HIV, there are few studies of interventions demonstrating improvements in adherence. This may be a particular challenge in the developing world, which has a larger burden of HIV but fewer resources than industrialized countries. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cell phone text message
- How many people
- 128 participants
- Where
- 1 siteBotswana
- Study dates
- Jun 2008to Aug 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- 21 years of age or older
Who cannot join
- Subjects who do not intend to have continuous follow-up care and monthly medication refills at Independence Surgery for at least the next six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Cellular Phone Text Message Reminders to Improve HIV Medication Adherence at Independence Surgery Clinic Gaborone, Botswana
While medication adherence is critical to successful treatment of HIV, there are few studies of interventions demonstrating improvements in adherence. This may be a particular challenge in the developing world, which has a larger burden of HIV but fewer resources than industrialized countries. The investigators propose a randomized controlled trial of cellular phone text message reminders to improve medication adherence. Our pilot study will be set in a large HIV clinic in Gaborone, Botswana, where Penn researchers have collaborated on research projects in the past. The primary study outcome will be antiretroviral medication adherence.
- Conditions
- HIV Infections
- Being tested
- Cell phone text message
- Keywords
- HIV, Antiretrovirals, Adherence, Text messaging, Antiretroviral adherence, Treatment experienced
- 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 text messageOther
We will use cellular text messages to remind patients of impending drug prescription refills and scheduled visits to their healthcare provider.
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV medication adherence
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startJun 2008
- Primary completionAug 2009
- Study completionAug 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 HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darren Linkin, MD, Study director, University of PennsylvaniaHarvey Friedman, MD, Principal investigator, University of PennsylvaniaJames Thompson, MBA, Study director, Wharton Business School, UPennAndrew Steenhoff, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001741
- Sponsor's protocol ID
- 805891
- Other IDs
- NIH: P30 AI 045008
- Status last verified
- Jun 2010
- First submitted
- 23 Oct 2009
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Reid MJ, Dhar SI, Cary M, Liang P, Thompson J, Gabaitiri L, Steele K, Mayisela S, Dickinson D, Friedman H, Linkin DR, Steenhoff AP. Opinions and attitudes of participants in a randomized controlled trial examining the efficacy of SMS reminders to enhance antiretroviral adherence: a cross-sectional survey. J Acquir Immune Defic Syndr. 2014 Feb 1;65(2):e86-8. doi: 10.1097/QAI.0b013e3182a9c72b. No abstract available.
PubMed 24442231
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cellular Phone Text Message Reminders to Improve HIV Medication Adherence at Independence Surgery Clinic Gaborone, Botswana
- ClinicalTrials.gov ID
- NCT01001741
- Acronym / sponsor ID
- 805891
- Conditions
- HIV Infections
- Keywords
- HIV, Antiretrovirals, Adherence, Text messaging, Antiretroviral adherence, Treatment experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Oct 2009 (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.
While medication adherence is critical to successful treatment of HIV, there are few studies of interventions demonstrating improvements in adherence. This may be a particular challenge in the developing world, which has a larger burden of HIV but fewer resources than industrialized countries. The investigators propose a randomized controlled trial of cellular phone text message reminders to improve medication adherence. Our pilot study will be set in a large HIV clinic in Gaborone, Botswana, where Penn researchers have collaborated on research projects in the past. The primary study outcome will be antiretroviral medication adherence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV infected
- 21 years of age or older
Key exclusion criteria (1 listed)
- Subjects who do not intend to have continuous follow-up care and monthly medication refills at Independence Surgery for at least the next six 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 |
|---|---|---|
| Cell phone text messageWe will use cellular text messages to remind patients of impending drug prescription refills and scheduled visits to their healthcare provider. | Other | – |
Primary outcome
HIV medication adherence
Time frame: Monthly
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 17 Sep 2015.
- Results publication: PubMed 24442231Reid MJ, Dhar SI, Cary M, Liang P, Thompson J, Gabaitiri L, Steele K, Mayisela S, Dickinson D, Friedman H, Linkin DR, Steenhoff AP. Opinions and attitudes of participants in a randomized controlled trial examining the efficacy of SMS reminders to enhance antiretroviral adherence: a cross-sectional survey. J Acquir Immune Defic Syndr. 2014 Feb 1;65(2):e86-8. doi: 10.1097/QAI.0b013e3182a9c72b. No abstract available.
- University of Pennsylvania in BotswanaLink provided by the sponsor.
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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.
Darren Linkin, MD study director
University of Pennsylvania
Harvey Friedman, MD principal investigator
University of Pennsylvania
James Thompson, MBA study director
Wharton Business School, UPenn
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 text message in people with HIV Infections, run by University of Pennsylvania at 1 site in Botswana.
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 2 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 17 Sep 2015. 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 Botswana. 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?
HIV medication adherence (time frame: Monthly). 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 NCT01001741, 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 17 Sep 2015.