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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections, Acquired Immunodeficiency Syndrome

Intervention / Treatment
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* Other: Text message


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PMTCT, SMS, HIV Infections, Acquired Immunodeficiency Syndrome, Prevention & Control, Patient Compliance, Cellular Phone, Randomized Controlled Trial