Does Provision of Point of Care CD4 Technology and Early Knowledge of CD4 Levels Affect Early Initiation and Retention on Anti-retroviral Treatment (ART) in HIV Positive Pregnant Women in the Context of Option B+ for PMTCT? (E4E)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by WHO, Department of Maternal, Newborn, Child and Adolescent Health
Sponsor:
Collaborators:
Canadian International Development Agency
Netherlands: Ministry of Health, Welfare and Sports
Information provided by (Responsible Party):
WHO, Department of Maternal, Newborn, Child and Adolescent Health
ClinicalTrials.gov Identifier:
NCT02070900
First received: February 18, 2014
Last updated: February 20, 2014
Last verified: February 2014

February 18, 2014
February 20, 2014
January 2014
June 2015   (final data collection date for primary outcome measure)
Retention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Proportion of HIV positive pregnant women that are retained on ART, 12 months after initiation
Same as current
Complete list of historical versions of study NCT02070900 on ClinicalTrials.gov Archive Site
  • Time-to-initiation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Median time-to-initiation between HIV positive diagnosis and enrolment onto Option B+ with or without POC CD4 and related counseling/support
  • Retention at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of HIV positive pregnant women that are retained on ART, 6 months after initiation in settings implementing option B+ with or without POC CD4 and related counseling/support
  • Retention by CD4 count [ Time Frame: 6 months , 12 months ] [ Designated as safety issue: No ]
    Proportion of women initiated and retained on ART at 6 and 12 months post ART initiation, according to different levels of CD4 count
  • Cost per pregnant woman retained on ART [ Time Frame: 6 months , 12 months ] [ Designated as safety issue: No ]
  • Initiation within 1 month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Proportion of HIV positive pregnant women initiating ART within 1 month of positive HIV test
Same as current
Not Provided
Not Provided
 
Does Provision of Point of Care CD4 Technology and Early Knowledge of CD4 Levels Affect Early Initiation and Retention on Anti-retroviral Treatment (ART) in HIV Positive Pregnant Women in the Context of Option B+ for PMTCT?
Does Provision of Point of Care CD4 Technology and Early Knowledge of CD4 Levels Affect Early Initiation and Retention on Anti-retroviral Treatment (ART) in HIV Positive Pregnant Women in the Context of Option B+ for PMTCT?

The study will be conducted at 32 health care facilities in three provinces in Zimbabwe and will compare the impact of the provision Point of Care CD4 technology and early knowledge of CD4 levels on retention at 12 months, with or without POC CD4 and a programmatic mentoring package. Option B+ will be implemented at all sites and 16 intervention sites will receive POC CD4 machines and visits from a team of clinical mentors.

The study also aims to assess rates of ART initiation and time to ART initiation of HIV positive pregnant women in settings implementing option B+ with or without POC CD4 and related counselling/support; rates of retention in care of HIV positive mothers at 6 months post ART initiation in settings implementing option B+ with or without POC CD4 and related counselling/support; rates of ART initiation and retention at 6 and 12 months post ART initiation according to different levels of CD4 count; cost of retaining HIV positive pregnant women until 6 and 12 months; acceptability and feasibility of POC CD4 as an adjunct to good clinical care of HIV positive pregnant women.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV/AIDS
  • Device: POC CD4
    Point of Care device for CD4 count testing (to be used as a clinical monitoring tool)
    Other Name: Alere PIMA
  • Other: Programmatic Mentoring
    Programmatic Mentoring aimed at messaging around CD4 count to encourage retention on lifelong ART for PMTCT patients, administered by trained clinical mentors
  • No Intervention: Standard of Care
    Sites implementing Option B+ for pregnant and lactating women according to the standard of care prescribed by the Ministry of health and Child Care national guidelines
  • Experimental: POC Plus
    Sites implementing Option B+ according to the standard of care prescribed by the Ministry of Health and Child Care, as well as programmatic mentoring and POC CD4 machines
    Interventions:
    • Device: POC CD4
    • Other: Programmatic Mentoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
704
July 2016
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant at the time of booking
  • HIV positive diagnosis
  • Not on ART at the time of booking
  • Present up to 38 weeks into gestation
  • Presents more than 48 hours prior to delivery

Exclusion Criteria:

  • Already on ART at booking
  • Presents more than 38 weeks into gestation or less than 48 hours prior to delivery
Female
Not Provided
Yes
Contact: Alexio Z Mangwiro amangwiro@clintonhealthaccess.org
Zimbabwe
 
NCT02070900
WHOCHAIZIMBABWE-001
Yes
WHO, Department of Maternal, Newborn, Child and Adolescent Health
WHO, Department of Maternal, Newborn, Child and Adolescent Health
  • Canadian International Development Agency
  • Netherlands: Ministry of Health, Welfare and Sports
Principal Investigator: Alexio Mangwiro Clinton Health Access Initiative, Nigeria
WHO, Department of Maternal, Newborn, Child and Adolescent Health
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP