Supporting Attendance for Facility Delivery and Infant Health

Study Overview
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Brief Summary
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The goal of this proposed intervention study is to increase the proportion of HIV positive and HIV negative pregnant women who deliver in a facility, the proportion of HIV exposed infants (HEI) who receive nevirapine (NVP) within 48 hours of delivery, and the proportion of HEI who are bled for HIV polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) testing within 8 weeks of age.

Detailed Description
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Following a formative phase I, we propose in phase II to implement a three-group cluster-randomized study to test the effectiveness of short message service (SMS) reminders and notifications, [mobile health or mhealth] (group 1) and the combined effectiveness of SMS reminders/notifications and cash transfers (group 2) compared to the standard prevention of mother-to-child transmission (of HIV)/maternal, neonatal and child health, (PMTCT/MNCH) practices (group 3).

Official Title
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Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania

Conditions
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HIV, AIDS

Intervention / Treatment
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* Behavioral: mHealth messaging
* Behavioral: Transport Payments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known or recently diagnosed HIV-positive in ANC or; Tested HIV-negative at ANC Plans to deliver in facility catchment area 18 years or older Able and willing to provide consent Exclusion Criteria: -

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinic group 1<br>Clinics using SMS health promotion and reminder messages (mhealth messaging) | Behavioral: mHealth messaging<br>* SMS appointment reminders and health messaging via mobile phones<br>|
| Experimental: Clinic group 2<br>Clinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments) | Behavioral: Transport Payments<br>* A payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area<br>|
| No Intervention: Clinic group 3<br>Services provided under the Ministry of Health standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance for Early infant diagnosis (EID) of HIV | Proportion of HIV-exposed infants (HEI) attending for early infant diagnosis of HIV (DBS collected) by 8 weeks | 1 year | 
| Early identification of HEI at Reproductive and Child Health (RCH) Clinic | Proportion of HEI identified early (48 hours,3 and 7 days) at RCH clinic | 1 year | 
| Antenatal care (ANC) visits | Proportion of pregnant women attending at least 4 ANC visits | 1 year | 
| Facility delivery | Proportion of pregnant women delivering in a health facility | 1 year | 
| Post natal care (PNC) visits | Proportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery | 1 year | 
| Nevirapine (NVP) at delivery | Proportion of HEI given NVP at delivery | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of EID results | Proportion of HEI who received EID results by 12 weeks | 1 year | 
| HIV infected infants initiated on antiretroviral therapy (ART) | Proportion of HIV infected infants initiated on ART by 12 weeks of age | 1 year | 
| Time to EID | Time (days/weeks) from date of birth to attendance for EID | 1 year | 
| Time to receipt of EID results | Time (days/weeks) from date of birth to receipt of EID results | 1 year | 
| Time to treatment | Time (days/weeks) from date of birth to initiation of ART | ! year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PMTCT, MNCH