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Supporting Attendance for Facility Delivery and Infant Health (SAFI)

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ClinicalTrials.gov Identifier: NCT03023033
Recruitment Status : Completed
First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Collaborators:
Population Council
Ministry of Health, Tanzania
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV AIDS Behavioral: mHealth messaging Behavioral: Transport Payments Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1505 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Enhancing Retention in PMTCT/MNCH Services and Facility Delivery in Tabora, Tanzania
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Clinic group 1
Clinics using SMS health promotion and reminder messages (mhealth messaging)
Behavioral: mHealth messaging
SMS appointment reminders and health messaging via mobile phones

Experimental: Clinic group 2
Clinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments)
Behavioral: Transport Payments
A payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area

No Intervention: Clinic group 3
Services provided under the Ministry of Health standard care



Primary Outcome Measures :
  1. Attendance for Early infant diagnosis (EID) of HIV [ Time Frame: 1 year ]
    Proportion of HIV-exposed infants (HEI) attending for early infant diagnosis of HIV (DBS collected) by 8 weeks

  2. Early identification of HEI at Reproductive and Child Health (RCH) Clinic [ Time Frame: 1 year ]
    Proportion of HEI identified early (48 hours,3 and 7 days) at RCH clinic

  3. Antenatal care (ANC) visits [ Time Frame: 1 year ]
    Proportion of pregnant women attending at least 4 ANC visits

  4. Facility delivery [ Time Frame: 1 year ]
    Proportion of pregnant women delivering in a health facility

  5. Post natal care (PNC) visits [ Time Frame: 1 year ]
    Proportion of post partum women attending PNC 48 hours, 3 and 7 days post delivery

  6. Nevirapine (NVP) at delivery [ Time Frame: 1 year ]
    Proportion of HEI given NVP at delivery


Secondary Outcome Measures :
  1. Receipt of EID results [ Time Frame: 1 year ]
    Proportion of HEI who received EID results by 12 weeks

  2. HIV infected infants initiated on antiretroviral therapy (ART) [ Time Frame: 1 year ]
    Proportion of HIV infected infants initiated on ART by 12 weeks of age

  3. Time to EID [ Time Frame: 1 year ]
    Time (days/weeks) from date of birth to attendance for EID

  4. Time to receipt of EID results [ Time Frame: 1 year ]
    Time (days/weeks) from date of birth to receipt of EID results

  5. Time to treatment [ Time Frame: ! year ]
    Time (days/weeks) from date of birth to initiation of ART



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023033


Locations
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Tanzania
Elizabeth Glaser Pediatric AIDS Foundation
Dar es Salaam, Tanzania
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
Population Council
Ministry of Health, Tanzania
Investigators
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Principal Investigator: Godfrey Woelk, MCOMMH, PhD Elizabeth Glaser Pediatric AIDS Foundation

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Responsible Party: Elizabeth Glaser Pediatric AIDS Foundation
ClinicalTrials.gov Identifier: NCT03023033     History of Changes
Other Study ID Numbers: EGPAF0130
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The dataset has been given to the USAID, the study sponsor. There is a plan to made these data publically available from 2018
Keywords provided by Elizabeth Glaser Pediatric AIDS Foundation:
PMTCT
MNCH