Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost

Study Overview
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Brief Summary
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Although gains have been made in achieving the health-related Millennium Development Goals (MDG), much is still needed in countries affected by high levels of HIV/AIDS. Prevention of mother-to-child transmission (PMTCT) is a cornerstone strategy in reducing infant mortality from HIV. The study will employ a cluster randomized control trial (cRCT) with 26 health facilities randomized to two arms (intervention or control) to determine the effect of mobile phone technology on completion of key PMTCT milestones from antenatal to six weeks postpartum. The study will examine the acceptability, effectiveness, and cost of implementing a PMTCT-focused mHealth strategy among HIV-infected pregnant women, health workers, and male partners.

Official Title
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Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost

Conditions
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HIV, HIV Infections, AIDS, Antiretroviral Therapy

Intervention / Treatment
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* Behavioral: Control
* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (female): HIV-positive pregnant women seeking ANC at a study site Up to 32 weeks gestation Own or have access to a mobile phone on which they can receive calls and SMS messages Exclusion Criteria (female): HIV-positive pregnant women who have already initiated antiretroviral treatment Inclusion Criteria (male): Referral by pregnant female partner
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br> | Behavioral: Control<br>* Health facilities where PMTCT services are available in the traditional clinical setting with HIV testing and counseling, PMTCT support, and enrollment in care and treatment.<br>|
| Intervention<br> | Behavioral: Intervention<br>* In addition to the 'Standard of Care', HIV-infected pregnant women and male partners within the PMTCT program are engaged in multi-directional mobile communication for PMTCT promotion with health care providers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum. |  |   6 months | 
| Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR |  |   6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake ARV prophylaxis/ART during labor, delivery, and postpartum |  |   6 months | 
| Self-reported maternal adherence to ARV prophylaxis/ART during pregnancy |  |   4 months | 
| Time to initiation of ARV prophylaxis/ART uptake after initial identification of HIV seropositivity within ANC |  |   1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, PMTCT, Mobile Phone, SMS