HIVTextITNCT02350140
Texting to Improve Testing (TextIT):
A study testing Text messaging from beginning in people with HIV, 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 14 years and older, women only
- Conditions the study is for
- HIV
- What is being tested?
- Text messaging from beginning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,508 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2015to Dec 2018
- 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 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Are ≥18 years or emancipated minors;
- Are at 28 weeks gestation or greater (or have delivered on the day of enrollment);
- Provide informed consent
Who cannot join
- Women who report sharing phones but have not disclosed their HIV status to the person with whom the phone is shared.
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: Texting to Improve Testing (TextIT): A Cluster Randomized Stepped Wedge Trial of Text Messaging to Improve Postpartum Retention in Care and Early Infant Diagnosis of HIV
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. The investigators recently concluded a successful randomized controlled trial in Kenya entitled, "Improving uptake of early infant diagnosis of HIV for prevention of mother-to-child HIV transmission (PMTCT): a randomized trial of a text messaging intervention" (ClinicalTrials.gov # NCT01433185). In this study, text messages developed using a behavioral theoretical framework significantly improved maternal attendance at post-partum clinic appointments and rates of testing to facilitate early infant diagnosis of HIV in a selected population and controlled setting. Understanding the effectiveness of this intervention (and its limitations) in a real-world, routine-care setting represents the next step in the translational pathway to public health impact. The investigators therefore now propose a cluster randomized, stepped wedge trial in 20 clinics operated by the Kenyan Ministry of Health in the Nyanza region of Kenya and use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) framework to understand the effectiveness of the text messaging to improve testing (TextIT) intervention. Our specific aims are:
- To determine the effect of TextIT on maternal attendance at postpartum clinic visits during the randomized stepped-wedge rollout of the intervention. Hypothesis 1: A greater proportion of women at health facilities implementing TextIT will attend clinic within eight weeks postpartum compared to women at health facilities implementing standard care.
- To determine the effect of TextIT on virological infant HIV testing within eight weeks after birth during the randomized stepped-wedge rollout of the intervention. Hypothesis 2: Infants of women at health facilities implementing TextIT will be more likely to have virological HIV testing compared to infants of women at health facilities implementing standard care.
- To determine the costs and cost-effectiveness of TextIT. The investigators will estimate the cost per patient and per health gain achieved (disability-adjusted life year, DALY) comparing TextIT to current standard care.
Hypothesis 3: The TextIT intervention will be more cost-effective than current standard care.
Read the detailed description
The 2011 United Nations General Assembly Political Declaration on HIV/AIDS set a target to eliminate mother-to-child transmission of HIV by 2015. The continuum of care for women living with HIV and their babies includes retention in care and early infant diagnosis of HIV. Timely initiation of infant antiretroviral therapy (ART) requires HIV-positive women to be retained in care through the postpartum period and to bring their children for HIV testing. However, a high proportion of pregnant HIV-positive women in sub-Saharan Africa are lost to follow-up after delivery. The World Health Organization recommends infant HIV testing at six weeks using DNA polymerase chain reaction (PCR). However, the overall proportion of children who undergo early infant diagnosis by PCR remains low. In Kenya, the overall proportion of eligible children undergoing PCR testing in 2011 was 39%.
Low rates of infant HIV testing are an indirect indication of a large number of infants who may not benefit from early determination of HIV status, antiretroviral prophylaxis for HIV-negative breastfeeding infants, and infant feeding counseling and support. For HIV positive infants, failure to undergo testing is a critical barrier to receiving life-saving ART. There is an urgent need to investigate efficacious, cost-effective, and sustainable interventions to improve maternal retention in HIV care and increase the proportion of exposed infants tested for HIV.
With the exponential increase in the number of mobile phones in sub-Saharan Africa, the use of mobile technology to support HIV programs has shown promise. The United Nations Children's Fund is encouraging HIV programs to take advantage of high levels of mobile phone access among enrolled mothers by reminding them to return for critical appointments. Active follow-up of pregnant HIV positive women in resource-limited settings using mobile phones is feasible, and may be effective in improving postnatal retention and uptake of early infant diagnosis across different sub-Saharan African settings.
- Conditions
- HIV
- Being tested
- Text messaging from beginning, Text messaging after 6 months of control
- Keywords
- HIV, Prevention of mother-to-child HIV transmission, PMTCT, mobile health (mHealth), mobile phone, text messaging, short message services (SMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messaging from beginningOther
Also called TextIT
Registered women will then receive up to 14 text messages as follows: weeks 28, 30, 32, 34, 36, 38, 39, and 40 during the third trimester of pregnancy; weeks 1, 2, 3, 4, 5, and 6 after delivery.Participants at facilities receiving TextIT will have the option to call or send text messages to a designated clinic phone, to which a clinic nurse will respond. Participants will also have an option to request a call from the clinic by sending a free "call back" text message to the designated clinic phone at any time.
Text messaging after 6 months of controlOther
After six months of standard care, women at control clinics will be registered to receive the text messaging intervention with up to 14 text messages as follows: weeks 28, 30, 32, 34, 36, 38, 39, and 40 during the third trimester of pregnancy; weeks 1, 2, 3, 4, 5, and 6 after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Text messaging from beginning | Experimental | Half of the health facilities will be randomly allocated to receive the TextIT intervention during the first time period (six months), while the other half to continue with current standard care (first step) Receives: Other: Text messaging from beginning |
| Text messaging after 6 months of control | Active comparator | Half the facilities will receive standard of care for six months (first time period). After the first time period, the these facilities will then also receive the TextIT intervention (second step) Receives: Other: Text messaging after 6 months of control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum retention in prevention of mother-to-child HIV transmission programs
Maternal attendance at postpartum clinic visits within eight weeks after delivery
Measured: 1 year
Infant HIV testing by DNA PCR within 8 weeks after birth
Measured: 1 year
Cost-effectiveness of TextIT
Measured: 1 year
Secondary outcomes (7)
Overall public health impact
To determine the overall public health impact of the TextIT strategy using the REAIM framework which assesses five dimensions of public health interventions: Reach, Effectiveness, Adoption, Implementation, and Maintenance
Measured: 1 year
Place of delivery and skilled birth attendance
Measured: 1 year
A combined outcome for stillbirth (after 28 weeks of pregnancy) or infant death within the first two months after a live birth
Measured: 1 year
Birth weight
Measured: 1 year
Reported infant feeding option
Measured: 1 year
Incidence rate of HIV-1 among infants who undergo virological HIV testing
Measured: 1 year
18 month PMTCT outcomes
Includes discharge from the PMTCT program, referral and linkage to the general HIV comprehensive care clinic, transfer out to another health facility, lost to follow-up or death; and infant HIV status by antibody testing.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Thomas Odeny, Kenya Medical Research Institute
- Investigators
- Thomas A Odeny, MBChB, MPH, Principal investigator, Kenya Medical Research InstituteScott R McClelland, MD MPH, Study chair, University of WashingtonCraig R Cohen, MD MPH, Study chair, University of California, San FranciscoElizabeth Bukusi, MBCHB PHD, Study chair, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350140
- Sponsor's protocol ID
- 41186
- Acronym
- TextIT
- Status last verified
- Nov 2017
- First submitted
- 19 Jan 2015
- Last updated
- 8 May 2018
- 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 25181408Odeny TA, Hughes JP, Bukusi EA, Akama E, Geng EH, Holmes KK, McClelland RS. Text messaging for maternal and infant retention in prevention of mother-to-child HIV transmission services: A pragmatic stepped-wedge cluster-randomized trial in Kenya. PLoS Med. 2019 Oct 2;16(10):e1002924. doi: 10.1371/journal.pmed.1002924. eCollection 2019 Oct.
PubMed 31577792
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Texting to Improve Testing (TextIT): A Cluster Randomized Stepped Wedge Trial of Text Messaging to Improve Postpartum Retention in Care and Early Infant Diagnosis of HIV
- ClinicalTrials.gov ID
- NCT02350140
- Acronym / sponsor ID
- TextIT / 41186
- Conditions
- HIV
- Keywords
- HIV, Prevention of mother-to-child HIV transmission, PMTCT, mobile health (mHealth), mobile phone, text messaging, short message services (SMS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,508 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Jan 2015 (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. The investigators recently concluded a successful randomized controlled trial in Kenya entitled, "Improving uptake of early infant diagnosis of HIV for prevention of mother-to-child HIV transmission (PMTCT): a randomized trial of a text messaging intervention" (ClinicalTrials.gov # NCT01433185). In this study, text messages developed using a behavioral theoretical framework significantly improved maternal attendance at post-partum clinic appointments and rates of testing to facilitate early infant diagnosis of HIV in a selected population and controlled setting. Understanding the effectiveness of this intervention (and its limitations) in a real-world, routine-care setting represents the next step in the translational pathway to public health impact. The investigators therefore now propose a cluster randomized, stepped wedge trial in 20 clinics operated by the Kenyan Ministry of Health in the Nyanza region of Kenya and use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) framework to understand the effectiveness of the text messaging to improve testing (TextIT) intervention. Our specific aims are:
- To determine the effect of TextIT on maternal attendance at postpartum clinic visits during the randomized stepped-wedge rollout of the intervention. Hypothesis 1: A greater proportion of women at health facilities implementing TextIT will attend clinic within eight weeks postpartum compared to women at health facilities implementing standard care.
- To determine the effect of TextIT on virological infant HIV testing within eight weeks after birth during the randomized stepped-wedge rollout of the intervention. Hypothesis 2: Infants of women at health facilities implementing TextIT will be more likely to have virological HIV testing compared to infants of women at health facilities implementing standard care.
- To determine the costs and cost-effectiveness of TextIT. The investigators will estimate the cost per patient and per health gain achieved (disability-adjusted life year, DALY) comparing TextIT to current standard care.
Hypothesis 3: The TextIT intervention will be more cost-effective than current standard care.
Detailed description
The 2011 United Nations General Assembly Political Declaration on HIV/AIDS set a target to eliminate mother-to-child transmission of HIV by 2015. The continuum of care for women living with HIV and their babies includes retention in care and early infant diagnosis of HIV. Timely initiation of infant antiretroviral therapy (ART) requires HIV-positive women to be retained in care through the postpartum period and to bring their children for HIV testing. However, a high proportion of pregnant HIV-positive women in sub-Saharan Africa are lost to follow-up after delivery. The World Health Organization recommends infant HIV testing at six weeks using DNA polymerase chain reaction (PCR). However, the overall proportion of children who undergo early infant diagnosis by PCR remains low. In Kenya, the overall proportion of eligible children undergoing PCR testing in 2011 was 39%.
Low rates of infant HIV testing are an indirect indication of a large number of infants who may not benefit from early determination of HIV status, antiretroviral prophylaxis for HIV-negative breastfeeding infants, and infant feeding counseling and support. For HIV positive infants, failure to undergo testing is a critical barrier to receiving life-saving ART. There is an urgent need to investigate efficacious, cost-effective, and sustainable interventions to improve maternal retention in HIV care and increase the proportion of exposed infants tested for HIV.
With the exponential increase in the number of mobile phones in sub-Saharan Africa, the use of mobile technology to support HIV programs has shown promise. The United Nations Children's Fund is encouraging HIV programs to take advantage of high levels of mobile phone access among enrolled mothers by reminding them to return for critical appointments. Active follow-up of pregnant HIV positive women in resource-limited settings using mobile phones is feasible, and may be effective in improving postnatal retention and uptake of early infant diagnosis across different sub-Saharan African settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text messaging from beginning | Experimental | Other: Text messaging from beginningHalf of the health facilities will be randomly allocated to receive the TextIT intervention during the first time period (six months), while the other half to continue with current standard care (first step) |
| Text messaging after 6 months of control | Active comparator | Other: Text messaging after 6 months of controlHalf the facilities will receive standard of care for six months (first time period). After the first time period, the these facilities will then also receive the TextIT intervention (second step) |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Are ≥18 years or emancipated minors;
- Are at 28 weeks gestation or greater (or have delivered on the day of enrollment);
- Provide informed consent
Key exclusion criteria (1 listed)
- Women who report sharing phones but have not disclosed their HIV status to the person with whom the phone is shared.
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 messaging from beginningAlso: TextITRegistered women will then receive up to 14 text messages as follows: weeks 28, 30, 32, 34, 36, 38, 39, and 40 during the third trimester of pregnancy; weeks 1, 2, 3, 4, 5, and 6 after delivery.Participants at facilities receiving TextIT will have the option to call or send text messages to a designated clinic phone, to which a clinic nurse will respond. Participants will also have an option to request a call from the clinic by sending a free "call back" text message to the designated clinic phone at any time. | Other | Text messaging from beginning |
| Text messaging after 6 months of controlAfter six months of standard care, women at control clinics will be registered to receive the text messaging intervention with up to 14 text messages as follows: weeks 28, 30, 32, 34, 36, 38, 39, and 40 during the third trimester of pregnancy; weeks 1, 2, 3, 4, 5, and 6 after delivery. | Other | Text messaging after 6 months of control |
Primary outcome
Postpartum retention in prevention of mother-to-child HIV transmission programs
Time frame: 1 year
Maternal attendance at postpartum clinic visits within eight weeks after delivery
Infant HIV testing by DNA PCR within 8 weeks after birth
Time frame: 1 year
Cost-effectiveness of TextIT
Time frame: 1 year
7 secondary outcomes
Overall public health impact
Time frame: 1 year
Place of delivery and skilled birth attendance
Time frame: 1 year
A combined outcome for stillbirth (after 28 weeks of pregnancy) or infant death within the first two months after a live birth
Time frame: 1 year
Birth weight
Time frame: 1 year
Reported infant feeding option
Time frame: 1 year
Incidence rate of HIV-1 among infants who undergo virological HIV testing
Time frame: 1 year
18 month PMTCT outcomes
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Background: 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.
- Background: 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.
- Derived from this study: PubMed 31577792Odeny TA, Hughes JP, Bukusi EA, Akama E, Geng EH, Holmes KK, McClelland RS. Text messaging for maternal and infant retention in prevention of mother-to-child HIV transmission services: A pragmatic stepped-wedge cluster-randomized trial in Kenya. PLoS Med. 2019 Oct 2;16(10):e1002924. doi: 10.1371/journal.pmed.1002924. eCollection 2019 Oct.
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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
Kenya Medical Research Institute
Scott R 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 messaging from beginning in people with HIV, 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 3 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: status not confirmed, as of the sponsor's last update on 8 May 2018. 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?
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?
Postpartum retention in prevention of mother-to-child HIV transmission programs (time frame: 1 year). The study lists 3 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 NCT02350140, which also lists 3 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 8 May 2018.