NCT03023033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,505

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

February 27, 2015

Last Update Submit

February 3, 2021

Conditions

HIVAIDS

Keywords

PMTCTMNCH

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • Receipt of EID results

    1 year

  • HIV infected infants initiated on antiretroviral therapy (ART)

    1 year

  • Time to EID

    1 year

  • Time to receipt of EID results

    1 year

  • Time to treatment

    ! year

Study Arms (3)

Clinic group 1

EXPERIMENTAL

Clinics using SMS health promotion and reminder messages (mhealth messaging)

Behavioral: mHealth messaging

Clinic group 2

EXPERIMENTAL

Clinics using SMS health promotion and reminder messages + Clinics providing payment scaled to reflect typical transport costs to facility (transport payments)

Behavioral: Transport Payments

Clinic group 3

NO INTERVENTION

Services provided under the Ministry of Health standard care

Interventions

mHealth messagingBEHAVIORAL

SMS appointment reminders and health messaging via mobile phones

Clinic group 1
Transport PaymentsBEHAVIORAL

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

Clinic group 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known or recently diagnosed HIV-positive in ANC or; Tested HIV-negative at ANC
  • Plans to deliver in facility catchment area
  • years or older
  • Able and willing to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elizabeth Glaser Pediatric AIDS Foundation

Dar es Salaam, Tanzania

Location

Related Publications (1)

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

    PMID: 32813276DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Godfrey Woelk, MCOMMH, PhD

    Elizabeth Glaser Pediatric AIDS Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2015

First Posted

January 18, 2017

Study Start

October 1, 2014

Primary Completion

March 1, 2016

Study Completion

November 1, 2016

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

The dataset has been given to the USAID, the study sponsor. There is a plan to made these data publically available from 2018

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
The plan is for the data to become available in 2018
Access Criteria
Access criteria will be defined by USAID

Locations

TA(1)