Texting to Improve Testing (TextIT):

NCT02350140 | Unknown

• 1 other identifier: 41186
• Study Type: interventional
• Target: 2,508
• Locations: 1 country
• Sites: 1

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. 1.To determine the effect of TextIT on maternal attendance at postpartum clinic visits during the randomized stepped-wedge rollout of the intervention.
2. 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.
3. 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.

Conditions

HIV

Keywords

HIV; Prevention of mother-to-child HIV transmission; PMTCT; mobile health (mHealth); mobile phone; text messaging; short message services (SMS)

Outcome Measures

Primary Outcomes (3)

• Postpartum retention in prevention of mother-to-child HIV transmission programs

  Maternal attendance at postpartum clinic visits within eight weeks after delivery

  1 year

• Infant HIV testing by DNA PCR within 8 weeks after birth

  1 year

• Cost-effectiveness of TextIT

  1 year

Secondary Outcomes (7)

• Overall public health impact

  1 year

• Place of delivery and skilled birth attendance

  1 year

• A combined outcome for stillbirth (after 28 weeks of pregnancy) or infant death within the first two months after a live birth

  1 year

• Birth weight

  1 year

• Reported infant feeding option

  1 year

Study Arms (2)

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)

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)

Other: Text messaging after 6 months of control

Interventions

Text messaging from beginning OTHER

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.

Also known as: TextIT

Text messaging from beginning

Text messaging after 6 months of control OTHER

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.

Text messaging after 6 months of control

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Kenya Medical Research Institute, Family AIDS Care and Education Services

Kisumu, Nyanza, Kenya

Location

Related Publications (3)

• 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.

  PMID: 25313586 BACKGROUND

• 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.

  PMID: 25181408 BACKGROUND

• 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.

  PMID: 31577792 DERIVED

Study Officials

• Thomas A Odeny, MBChB, MPH

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

• Scott R McClelland, MD MPH

  University of Washington

  STUDY CHAIR

• Craig R Cohen, MD MPH

  University of California, San Francisco

  STUDY CHAIR

• Elizabeth Bukusi, MBCHB PHD

  Kenya Medical Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 29, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: May 8, 2018

Record last verified: 2017-11

Locations

KE (1)