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

Not Applicable

Completed

• Conditions: HIV Infections; Acquired Immunodeficiency Syndrome
• Interventions: Other: Text message

• Registration Number: NCT01433185
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-12
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-13
• Study Start: 2012-04
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 388

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text message (SMS)	Text message	Text messages sent to women before and after delivery

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Maternal adherence to antiretroviral prophylaxis	Up to 8 weeks after delivery
Infant adherence to antiretroviral prophylaxis	Up to 6 weeks after delivery
Time to post-natal clinic return	Up to 8 weeks after delivery

Trial Locations

Locations (1)

Kenya Medical Research Institute, Family AIDS Care and Education Services; 🇰🇪 Kisumu, Nyanza, Kenya