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

HIV Infections Clinical Trial

— SMS4PMTCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433185
• Other study ID #: 41186-E/G
• Status: Completed
• Phase: N/A
• First received: September 12, 2011
• Last updated: January 19, 2015
• Start date: April 2012
• Est. completion date: July 2013

Study information

• Verified date: January 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Other:
• Text message
Text messages sent to women before and after delivery

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute, Family AIDS Care and Education Services	Kisumu	Nyanza

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Kenya Medical Research Institute, University of California, San Francisco

Country where clinical trial is conducted

Kenya, 

References & Publications (2)

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 — View 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 st — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women who attend postnatal clinic within 6-8 weeks postpartum		6-8 weeks after delivery	No
Primary	Proportion of infants tested for HIV by DNA PCR		6-8 weeks after delivery	No
Secondary	Infant adherence to antiretroviral prophylaxis		Up to 6 weeks after delivery	No
Secondary	Time to post-natal clinic return		Up to 8 weeks after delivery	No
Secondary	Maternal adherence to antiretroviral prophylaxis		Up to 8 weeks after delivery	No