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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02350140
Date of registration:	19/01/2015
Prospective Registration:	No
Primary sponsor:	University of Washington
Public title:	Texting to Improve Testing (TextIT): TextIT
Scientific 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
Date of first enrolment:	January 2015
Target sample size:	2508
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT02350140
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Kenya

Contacts

Name:	Thomas A Odeny, MBChB, MPH
Address:
Telephone:
Email:
Affiliation:	Kenya Medical Research Institute

Name:	Elizabeth Bukusi, MBCHB PHD
Address:
Telephone:
Email:
Affiliation:	Kenya Medical Research Institute

Name:	Craig R Cohen, MD MPH
Address:
Telephone:
Email:
Affiliation:	University of California, San Francisco

Name:	Scott R McClelland, MD MPH
Address:
Telephone:
Email:
Affiliation:	University of Washington

Key inclusion & exclusion 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.

Age minimum: 14 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Other: Text messaging from beginning

Other: Text messaging after 6 months of control

Primary Outcome(s)

Infant HIV testing by DNA PCR within 8 weeks after birth [Time Frame: 1 year]

Cost-effectiveness of TextIT [Time Frame: 1 year]

Postpartum retention in prevention of mother-to-child HIV transmission programs [Time Frame: 1 year]

Secondary Outcome(s)

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]

Overall public health impact [Time Frame: 1 year]

Place of delivery and skilled birth attendance [Time Frame: 1 year]

Reported infant feeding option [Time Frame: 1 year]

18 month PMTCT outcomes [Time Frame: 18 months]

Incidence rate of HIV-1 among infants who undergo virological HIV testing [Time Frame: 1 year]

Birth weight [Time Frame: 1 year]

Secondary ID(s)

41186

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of California, San Francisco

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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