HIV InfectionsNCT01157442
Study of Cell Phone SMS Messages for Prevention of Maternal to Child Transmission of HIV
A study testing cell phone sms text messaging in people with HIV Infections, run by University of Manitoba at 1 site in Kenya.
Trial summary
Optimal development of sustainable health systems must use locally relevant infrastructure. Mobile phone technology, driven primarily by local market forces rather than foreign assistance, is spreading rapidly through African communities to improve people's personal and business communications. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- 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
- 856 participants
- Where
- 1 siteKenya
- Study dates
- Jul 2010to Mar 2012
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women will be eligible to participate if they:
- are pregnant with a singleton pregnancy,
- attend care at Pumwani Maternity Hospital,
- are HIV positive,
- have never had a preterm birth (before 37 weeks),
- are planning to reside in Nairobi for at least 6 months post delivery,
Show all 9Show fewer
- live within 15 km of PMH,
- have basic literacy skills in Kiswahili or English,
- are willing to be contacted for follow up and have their own cell phone or regular access to their partners' cell phone (partners must be aware of their HIV status).
Who cannot join
- Women who are pregnant and attend care at Pumwani Maternity Hospital who are not HIV positive,
- Women who have had a preterm birth,
- Women who are not planning to reside in Nairobi for at least 6 months post delivery,
- Women who do not live within 15 km of PMH,
- Women who do not have basic literacy skills in English or Kiswahili
- Women who are not willing to be contacted for follow up,
- Women who do not have their own cell phone or regular access to their partner's cell phone and
- Women whose partner's are not aware of their HIV status.
Trial locations and contacts
1 site in 1 country.
Joshua Kimani, MD contact
Kenya1 site, 1 recruiting
- Recruiting
Pumwani Maternity Hospital
Nairobi
Mary Gichuhi, gichuhimary@yahoo.com
About this study
Official title: Harnessing Mobile Phone Usage for HIV and Horizontal Health Systems Improvement: PMTCT
Optimal development of sustainable health systems must use locally relevant infrastructure. Mobile phone technology, driven primarily by local market forces rather than foreign assistance, is spreading rapidly through African communities to improve people's personal and business communications. Here, the investigators propose using a structured mobile phone communications system for prevention of mother to child transmission of HIV (PMTCT). The system is designed to improve antenatal linkage to care, provide reminders to take PMTCT medications, and improve post-natal support and follow-up, even when mothers deliver at home. In addition to benefits in PMTCT related outcomes, this model allows evaluation of the intervention in a public health setting with the ultimate goal of advancing regional health systems development. The overall goal of of the study is to assess if mobile phones and SMS text messages can be used to help improve prevention of maternal to child transmission (PMTCT) of HIV services by strengthening health systems.
Specific objectives are:
Read more
- To determine if mobile phone SMS text messages can demonstrate an improvement in compliance with a known intervention ( use of nevirapine) for PMTCT, demonstrated by:
1a) improved antenatal care attendance (greater than 4 visits)
1b) increased usage of nevirapine in labour (from 60% to at least 70%)
1c) earlier identification and treatment of HIV positive infants
1d) increased postpartum care for HIV positive mothers
1e) acceptability of cell phone SMS text messages transmission of information among HIV positive women
- To demonstrate that mobile phone technology can be used as an effective tool to strengthen PMTCT health information systems at the facility level by: 2a) determining factors that constrain or promote the use of cell phone technology to strengthen PMTCT health information systems from the perspective of patients, health care providers and policy makers 2b) determining how cell phones can be used as a tool to generate equity statistics for PMTCT programs and formulate equity orientated PMTCT policies 2c) determine if early involvement of policy makers in the study improves knowledge translation
- Conditions
- HIV Infections
- Being tested
- cell phone sms text messaging
- Keywords
- prevention of maternal to child transmission of HIV, mhealth, access to antenatal care, pregnancy
- 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
At enrollment a study nurse will send the intervention group a weekly SMS message reminding them to attend antenatal care. Starting at 36 weeks gestational age, an automated bulk SMS management system, will send the intervention group 3 SMS text messages (using non descript slogans) each week by proxy reminding them to take their nevirapine in labor. From time of delivery to 6 weeks postpartum the women will aslo receive 3 SMS messages per week reminding them to attend their 6 week checkup and 6 week infant visit.Upon receiving these messages women in the intervention group can text back if they have any concerns or questions. These women would then receive phone calls from the study nurse triaged according to the women's needs.
| Study group | Role | What they receive |
|---|---|---|
| cell phone sms messages | Experimental | The experimental arm will receive the cell phone SMS text messaging intervention. Receives: Behavioral: cell phone sms text messaging |
| Control | No intervention | The control group will receive the standard of care but no SMS text messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70%
Measured: At time of delivery and/or postpartum visit
Secondary outcomes (4)
HIV positive rates in infants born to mothers in the study
Measured: assessed at birth, 6 weeks and 3 months of age
number of antenatal care visits
Measured: assessed at time of 6 week postpartum visit
earlier identification and treatment of HIV positive infants
Measured: at 6 week infant visit
acceptability fo smsm messages for PMTCT related care
Measured: at 6 week postpartum visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 856 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nairobi, Canadian International Development Agency
- Investigators
- Joshua Kimani, MD, Principal investigator, University of Manitoba and University of NairobiPeter Cherutich, MD, Principal investigator, Ministry of Health, NASCOP KenyaMary Gichuihi, Masters, Study director, University of Nairobi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157442
- Sponsor's protocol ID
- H2009:315
- Status last verified
- Jul 2010
- First submitted
- 2 Jul 2010
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Mobile Phone Usage for HIV and Horizontal Health Systems Improvement: PMTCT
- ClinicalTrials.gov ID
- NCT01157442
- Acronym / sponsor ID
- H2009:315
- Conditions
- HIV Infections
- Keywords
- prevention of maternal to child transmission of HIV, mhealth, access to antenatal care, pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 856 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Nairobi, Canadian International Development Agency
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 7 Jul 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.
Optimal development of sustainable health systems must use locally relevant infrastructure. Mobile phone technology, driven primarily by local market forces rather than foreign assistance, is spreading rapidly through African communities to improve people's personal and business communications. Here, the investigators propose using a structured mobile phone communications system for prevention of mother to child transmission of HIV (PMTCT). The system is designed to improve antenatal linkage to care, provide reminders to take PMTCT medications, and improve post-natal support and follow-up, even when mothers deliver at home. In addition to benefits in PMTCT related outcomes, this model allows evaluation of the intervention in a public health setting with the ultimate goal of advancing regional health systems development. The overall goal of of the study is to assess if mobile phones and SMS text messages can be used to help improve prevention of maternal to child transmission (PMTCT) of HIV services by strengthening health systems.
Specific objectives are:
- To determine if mobile phone SMS text messages can demonstrate an improvement in compliance with a known intervention ( use of nevirapine) for PMTCT, demonstrated by:
1a) improved antenatal care attendance (greater than 4 visits)
1b) increased usage of nevirapine in labour (from 60% to at least 70%)
1c) earlier identification and treatment of HIV positive infants
1d) increased postpartum care for HIV positive mothers
1e) acceptability of cell phone SMS text messages transmission of information among HIV positive women
- To demonstrate that mobile phone technology can be used as an effective tool to strengthen PMTCT health information systems at the facility level by: 2a) determining factors that constrain or promote the use of cell phone technology to strengthen PMTCT health information systems from the perspective of patients, health care providers and policy makers 2b) determining how cell phones can be used as a tool to generate equity statistics for PMTCT programs and formulate equity orientated PMTCT policies 2c) determine if early involvement of policy makers in the study improves knowledge translation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cell phone sms messages | Experimental | Behavioral: cell phone sms text messagingThe experimental arm will receive the cell phone SMS text messaging intervention. |
| Control | No intervention | –The control group will receive the standard of care but no SMS text messages. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- are pregnant with a singleton pregnancy,
- attend care at Pumwani Maternity Hospital,
- are HIV positive,
- have never had a preterm birth (before 37 weeks),
- are planning to reside in Nairobi for at least 6 months post delivery,
Key exclusion criteria (8 listed)
- Women who are pregnant and attend care at Pumwani Maternity Hospital who are not HIV positive,
- Women who have had a preterm birth,
- Women who are not planning to reside in Nairobi for at least 6 months post delivery,
- Women who do not live within 15 km of PMH,
- Women who do not have basic literacy skills in English or Kiswahili
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 messagingAt enrollment a study nurse will send the intervention group a weekly SMS message reminding them to attend antenatal care. Starting at 36 weeks gestational age, an automated bulk SMS management system, will send the intervention group 3 SMS text messages (using non descript slogans) each week by proxy reminding them to take their nevirapine in labor. From time of delivery to 6 weeks postpartum the women will aslo receive 3 SMS messages per week reminding them to attend their 6 week checkup and 6 week infant visit.Upon receiving these messages women in the intervention group can text back if they have any concerns or questions. These women would then receive phone calls from the study nurse triaged according to the women's needs. | Behavioural | cell phone sms messages |
Primary outcome
increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70%
Time frame: At time of delivery and/or postpartum visit
4 secondary outcomes
HIV positive rates in infants born to mothers in the study
Time frame: assessed at birth, 6 weeks and 3 months of age
number of antenatal care visits
Time frame: assessed at time of 6 week postpartum visit
earlier identification and treatment of HIV positive infants
Time frame: at 6 week infant visit
acceptability fo smsm messages for PMTCT related care
Time frame: at 6 week postpartum visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
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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.
Joshua Kimani, MD contact
Joshua Kimani, MD principal investigator
University of Manitoba and University of Nairobi
Peter Cherutich, MD principal investigator
Ministry of Health, NASCOP Kenya
Mary Gichuihi, Masters study director
University of Nairobi
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 Infections, run by University of Manitoba 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Mar 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Kimani, MD (jkimani@csrtkenya.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increased nevirapine uptake in labour in pregnant HIV positive women from 60% to 70% (time frame: At time of delivery and/or postpartum visit). 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 Mar 2011.