Clinical trial NCT02350140: Texting to Improve Testing (TextIT):
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: HIV
Prevention of mother-to-child HIV transmission
PMTCT
mobile health (mHealth)
mobile phone
text messaging
short message services (SMS)
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2015-01-29
Enrollment: 2508
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. 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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

* Are ≥18 years or emancipated minors;
* Are at 28 weeks gestation or greater (or have delivered on the day of enrollment);
* Provide informed consent

Exclusion Criteria:

* Women who report sharing phones but have not disclosed their HIV status to the person with whom the phone is shared.

Primary outcomes:
measure: Postpartum retention in prevention of mother-to-child HIV transmission programs
timeFrame: 1 year
measure: Infant HIV testing by DNA PCR within 8 weeks after birth
timeFrame: 1 year
measure: Cost-effectiveness of TextIT
timeFrame: 1 year
Secondary outcomes:
measure: Overall public health impact
timeFrame: 1 year
measure: Place of delivery and skilled birth attendance
timeFrame: 1 year
measure: A combined outcome for stillbirth (after 28 weeks of pregnancy) or infant death within the first two months after a live birth
timeFrame: 1 year
measure: Birth weight
timeFrame: 1 year
measure: Reported infant feeding option
timeFrame: 1 year
measure: Incidence rate of HIV-1 among infants who undergo virological HIV testing
timeFrame: 1 year
measure: 18 month PMTCT outcomes
timeFrame: 18 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute, Family AIDS Care and Education Services
state: Nyanza
Study officials:
affiliation: Kenya Medical Research Institute
name: Thomas A Odeny, MBChB, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Scott R McClelland, MD MPH
role: STUDY_CHAIR
affiliation: University of California, San Francisco
name: Craig R Cohen, MD MPH
role: STUDY_CHAIR
affiliation: Kenya Medical Research Institute
name: Elizabeth Bukusi, MBCHB PHD
role: STUDY_CHAIR
References:
citation: 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.
citation: Odeny 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.
citation: Odeny 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.