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

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT01433185
• Collaborator: Kenya Medical Research Institute (Other), University of California, San Francisco (Other)
• Enrollment: 388
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 25.9

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; Acquired Immunodeficiency Syndrome	Other: Text message	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 388 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Improving Uptake of Early Infant Diagnosis of HIV for PMTCT: a Randomized Trial of a Text Messaging Intervention
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of women who attend postnatal clinic within 6-8 weeks postpartum [6-8 weeks after delivery]

2. Proportion of infants tested for HIV by DNA PCR [6-8 weeks after delivery]

Secondary Outcome Measures

1. Infant adherence to antiretroviral prophylaxis [Up to 6 weeks after delivery]

2. Time to post-natal clinic return [Up to 8 weeks after delivery]

3. Maternal adherence to antiretroviral prophylaxis [Up to 8 weeks after delivery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kenya Medical Research Institute, Family AIDS Care and Education Services	Kisumu	Nyanza	Kenya

Sponsors and Collaborators

• University of Washington
• Kenya Medical Research Institute
• University of California, San Francisco

Investigators

• 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
• Study Chair: Elizabeth A Bukusi, MBChB, MMed, MPH, PhD, Kenya Medical Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Odeny, Principal Investigator, University of Washington
• ClinicalTrials.gov Identifier: NCT01433185
• Other Study ID Numbers: 41186-E/G
• First Posted: Sep 13, 2011
• Last Update Posted: Jan 21, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Thomas Odeny, Principal Investigator, University of Washington: PMTCT; SMS; HIV Infections; Acquired Immunodeficiency Syndrome; Prevention & Control; Patient Compliance; Cellular Phone; Randomized Controlled Trial
• Additional relevant MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes

Study Results

No Results Posted as of Jan 21, 2015