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Completed

NCT Number: NCT03023033

Supporting Attendance for Facility Delivery and Infant Health

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.

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Key information

Conditions

HIV AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Elizabeth Glaser Pediatric AIDS Foundation

Dar es Salaam, Tanzania

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

mHealth messaging

Behavioral

SMS appointment reminders and health messaging via mobile phones

Transport Payments

Behavioral

A payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Other

Collaborators

  • Ministry of Health, Tanzania
  • Population Council

Registry information

Official study title

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

Acronym: SAFI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 18, 2017
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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