Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV (SMS4PMTCT)

Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention

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. There is little information on evidence-based interventions that specifically target improved attendance of postpartum clinic visits and subsequent infant HIV testing in the context of prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators propose a randomized controlled trial to examine the effect of text messages sent to women enrolled in PMTCT programs on adherence to postpartum clinic visits and uptake of early infant diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the hypotheses that (a) text messages sent to women enrolled in PMTCT will improve their attendance at the postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to women enrolled in PMTCT programs will increase uptake of DNA PCR HIV testing at 6-8 weeks among infants exposed to HIV. This study will evaluate a novel strategy to improve adherence to postnatal clinic visits and increase the uptake of infant HIV testing. If proven superior to standard care, the proposed intervention can be easily scaled-up and integrated into existing healthcare systems in resource-limited settings. Findings from this study will provide randomized trial evidence to inform HIV prevention program planners and implementers. This study will also provide further information on the feasibility of using mobile phone-based technology for public health interventions in resource-limited settings.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Acquired Immunodeficiency Syndrome
• Intervention / Treatment: Other: Text message

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nyanza
    • Kisumu, Nyanza, Kenya
      • Kenya Medical Research Institute, Family AIDS Care and Education Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• age at least 18 years
• report ability to read SMS
• ≥ 28 weeks gestation or delivery at study clinic on day of enrollment
• HIV positive women enrolled in the PMTCT program
• have access to a mobile phone (personal or partner's if HIV serostatus disclosed to partner)
• willing to receive SMS messages from the study
• planning to remain in the study area (Nyanza province) for the duration of the study

Exclusion Criteria:

• age less than 18 years old
• women who share phones with partners but HIV status not disclosed to partners
• intention to deliver at a non-study hospital

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Text message (SMS); Text messages sent to women before and after delivery	Other: Text message; Text messages sent to women before and after delivery; Other Names: SMS, short message service, text messaging
No Intervention: Usual care (current standard of care); Current standard of care for women enrolled in PMTCT programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of women who attend postnatal clinic within 6-8 weeks postpartum	6-8 weeks after delivery
Proportion of infants tested for HIV by DNA PCR	6-8 weeks after delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Infant adherence to antiretroviral prophylaxis	Up to 6 weeks after delivery
Time to post-natal clinic return	Up to 8 weeks after delivery
Maternal adherence to antiretroviral prophylaxis	Up to 8 weeks after delivery

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: University of California, San Francisco; Kenya Medical Research Institute
• Investigators: Study Chair: Elizabeth A Bukusi, MBChB, MMed, MPH, PhD, Kenya Medical Research Institute; Principal Investigator: Thomas A Odeny, MBChB, MPH, University of Washington/Kenya Medical Research Institute; Study Chair: R Scott McClelland, MD, MPH, University of Washington; Study Chair: Craig R Cohen, MD, MPH, University of California, San Francisco; Study Chair: Carol Camlin, PhD, University of California, San Francisco

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: September 12, 2011
• First Submitted That Met QC Criteria: September 12, 2011
• First Posted (Estimate): September 13, 2011

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 19, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Acquired Immunodeficiency Syndrome; Prevention & Control; HIV Infections; SMS; PMTCT; Patient Compliance; Cellular Phone
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: 41186-E/G