HIV InfectionsSMS4PMTCTNCT01433185
Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV
A study testing Text message in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by University of Washington at 1 site in Kenya.
Trial summary
Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome
- What is being tested?
- Text message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteKenya
- Study dates
- Apr 2012to Jul 2013
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age at least 18 years
- report ability to read SMS
- ≥ 28 weeks gestation or delivery at study clinic on day of enrollment
- HIV positive women enrolled in the PMTCT program
- have access to a mobile phone (personal or partner's if HIV serostatus disclosed to partner)
- willing to receive SMS messages from the study
- planning to remain in the study area (Nyanza province) for the duration of the study
Who cannot join
- age less than 18 years old
- women who share phones with partners but HIV status not disclosed to partners
- intention to deliver at a non-study hospital
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Kenya Medical Research Institute, Family AIDS Care and Education Services
Kisumu, Nyanza
About this study
Official title: Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention
Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. There is little information on evidence-based interventions that specifically target improved attendance of postpartum clinic visits and subsequent infant HIV testing in the context of prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators propose a randomized controlled trial to examine the effect of text messages sent to women enrolled in PMTCT programs on adherence to postpartum clinic visits and uptake of early infant diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the hypotheses that (a) text messages sent to women enrolled in PMTCT will improve their attendance at the postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to women enrolled in PMTCT programs will increase uptake of DNA PCR HIV testing at 6-8 weeks among infants exposed to HIV. This study will evaluate a novel strategy to improve adherence to postnatal clinic visits and increase the uptake of infant HIV testing. If proven superior to standard care, the proposed intervention can be easily scaled-up and integrated into existing healthcare systems in resource-limited settings. Findings from this study will provide randomized trial evidence to inform HIV prevention program planners and implementers. This study will also provide further information on the feasibility of using mobile phone-based technology for public health interventions in resource-limited settings.
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Being tested
- Text message
- Keywords
- PMTCT, SMS, HIV Infections, Acquired Immunodeficiency Syndrome, Prevention & Control, Patient Compliance, Cellular Phone, Randomized Controlled Trial
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messageOther
Also called SMS, short message service, text messaging
Text messages sent to women before and after delivery
| Study group | Role | What they receive |
|---|---|---|
| Text message (SMS) | Experimental | Text messages sent to women before and after delivery Receives: Other: Text message |
| Usual care (current standard of care) | No intervention | Current standard of care for women enrolled in PMTCT programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women who attend postnatal clinic within 6-8 weeks postpartum
Measured: 6-8 weeks after delivery
Proportion of infants tested for HIV by DNA PCR
Measured: 6-8 weeks after delivery
Secondary outcomes (3)
Infant adherence to antiretroviral prophylaxis
Measured: Up to 6 weeks after delivery
Time to post-natal clinic return
Measured: Up to 8 weeks after delivery
Maternal adherence to antiretroviral prophylaxis
Measured: Up to 8 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 WashingtonThe 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
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of California, San Francisco
- Responsible party
- Principal investigator, Thomas Odeny, University of Washington
- Investigators
- Thomas A Odeny, MBChB, MPH, Principal investigator, University of Washington/Kenya Medical Research InstituteR Scott McClelland, MD, MPH, Study chair, University of WashingtonCraig R Cohen, MD, MPH, Study chair, University of California, San FranciscoCarol Camlin, PhD, Study chair, University of California, San FranciscoElizabeth A Bukusi, MBChB, MMed, MPH, PhD, Study chair, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433185
- Sponsor's protocol ID
- 41186-E/G
- Acronym
- SMS4PMTCT
- Status last verified
- Jan 2015
- First submitted
- 12 Sep 2011
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Odeny TA, Bukusi EA, Cohen CR, Yuhas K, Camlin CS, McClelland RS. Texting improves testing: a randomized trial of two-way SMS to increase postpartum prevention of mother-to-child transmission retention and infant HIV testing. AIDS. 2014 Sep 24;28(15):2307-12. doi: 10.1097/QAD.0000000000000409.
PubMed 25313586Odeny TA, Newman M, Bukusi EA, McClelland RS, Cohen CR, Camlin CS. Developing content for a mHealth intervention to promote postpartum retention in prevention of mother-to-child HIV transmission programs and early infant diagnosis of HIV: a qualitative study. PLoS One. 2014 Sep 2;9(9):e106383. doi: 10.1371/journal.pone.0106383. eCollection 2014.
PubMed 25181408
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention
- ClinicalTrials.gov ID
- NCT01433185
- Acronym / sponsor ID
- SMS4PMTCT / 41186-E/G
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Keywords
- PMTCT, SMS, HIV Infections, Acquired Immunodeficiency Syndrome, Prevention & Control, Patient Compliance, Cellular Phone, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of California, San Francisco
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Sep 2011 (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.
Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. There is little information on evidence-based interventions that specifically target improved attendance of postpartum clinic visits and subsequent infant HIV testing in the context of prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators propose a randomized controlled trial to examine the effect of text messages sent to women enrolled in PMTCT programs on adherence to postpartum clinic visits and uptake of early infant diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the hypotheses that (a) text messages sent to women enrolled in PMTCT will improve their attendance at the postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to women enrolled in PMTCT programs will increase uptake of DNA PCR HIV testing at 6-8 weeks among infants exposed to HIV. This study will evaluate a novel strategy to improve adherence to postnatal clinic visits and increase the uptake of infant HIV testing. If proven superior to standard care, the proposed intervention can be easily scaled-up and integrated into existing healthcare systems in resource-limited settings. Findings from this study will provide randomized trial evidence to inform HIV prevention program planners and implementers. This study will also provide further information on the feasibility of using mobile phone-based technology for public health interventions in resource-limited settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text message (SMS) | Experimental | Other: Text messageText messages sent to women before and after delivery |
| Usual care (current standard of care) | No intervention | –Current standard of care for women enrolled in PMTCT programs |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age at least 18 years
- report ability to read SMS
- ≥ 28 weeks gestation or delivery at study clinic on day of enrollment
- HIV positive women enrolled in the PMTCT program
- have access to a mobile phone (personal or partner's if HIV serostatus disclosed to partner)
Key exclusion criteria (3 listed)
- age less than 18 years old
- women who share phones with partners but HIV status not disclosed to partners
- intention to deliver at a non-study hospital
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 |
|---|---|---|
| Text messageAlso: SMS, short message service, text messagingText messages sent to women before and after delivery | Other | Text message (SMS) |
Primary outcome
Proportion of women who attend postnatal clinic within 6-8 weeks postpartum
Time frame: 6-8 weeks after delivery
Proportion of infants tested for HIV by DNA PCR
Time frame: 6-8 weeks after delivery
3 secondary outcomes
Infant adherence to antiretroviral prophylaxis
Time frame: Up to 6 weeks after delivery
Time to post-natal clinic return
Time frame: Up to 8 weeks after delivery
Maternal adherence to antiretroviral prophylaxis
Time frame: Up to 8 weeks after delivery
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 21 Jan 2015.
- Results publication: PubMed 25313586Odeny TA, Bukusi EA, Cohen CR, Yuhas K, Camlin CS, McClelland RS. Texting improves testing: a randomized trial of two-way SMS to increase postpartum prevention of mother-to-child transmission retention and infant HIV testing. AIDS. 2014 Sep 24;28(15):2307-12. doi: 10.1097/QAD.0000000000000409.
- Results publication: PubMed 25181408Odeny TA, Newman M, Bukusi EA, McClelland RS, Cohen CR, Camlin CS. Developing content for a mHealth intervention to promote postpartum retention in prevention of mother-to-child HIV transmission programs and early infant diagnosis of HIV: a qualitative study. PLoS One. 2014 Sep 2;9(9):e106383. doi: 10.1371/journal.pone.0106383. eCollection 2014.
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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.
Thomas A Odeny, MBChB, MPH principal investigator
University of Washington/Kenya Medical Research Institute
R Scott McClelland, MD, MPH study chair
University of Washington
Craig R Cohen, MD, MPH study chair
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by University of Washington 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 7 inclusion and 3 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 21 Jan 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 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?
Proportion of women who attend postnatal clinic within 6-8 weeks postpartum (time frame: 6-8 weeks after delivery). 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?
On the ClinicalTrials.gov record for NCT01433185, which also lists 2 linked publications.
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 21 Jan 2015.