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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by WHO, Department of Maternal, Newborn, Child and Adolescent Health.
Recruitment status was:  Recruiting
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
  Purpose

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.


Condition Intervention
HIV/AIDS
Device: POC CD4
Other: Programmatic Mentoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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?

Resource links provided by NLM:


Further study details as provided by WHO, Department of Maternal, Newborn, Child and Adolescent Health:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 704
Study Start Date: January 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070900

Locations
Zimbabwe
Bromley
Goromonzi, Mashonaland East, Zimbabwe
Henry John Rheimer
Goromonzi, Mashonaland East, Zimbabwe
Kubatsirana
Goromonzi, Mashonaland East, Zimbabwe
Melfort
Goromonzi, Mashonaland East, Zimbabwe
Mwanza RHC
Goromonzi, Mashonaland East, Zimbabwe
Border Church RHC
Marondera, Mashonaland East, Zimbabwe
Chipararwe
Marondera, Mashonaland East, Zimbabwe
Lustleigh
Marondera, Mashonaland East, Zimbabwe
Masikana
Marondera, Mashonaland East, Zimbabwe
Charehwa
Mutoko, Mashonaland East, Zimbabwe
Kushinga RHC
Mutoko, Mashonaland East, Zimbabwe
Nyamazuwe Rural Hospital
Mutoko, Mashonaland East, Zimbabwe
Masasa
Seke, Mashonaland East, Zimbabwe
Mashambanhaka
UMP, Mashonaland East, Zimbabwe
Mdutshane RHC
Bubi, Matebeleland North, Zimbabwe
Membeswana RHC
Bubi, Matebeleland North, Zimbabwe
Lupaka
Lupane, Matebeleland North, Zimbabwe
Madlangombe
Tsholotsho, Matebeleland North, Zimbabwe
Makhaza RHC
Tsholotsho, Matebeleland North, Zimbabwe
Mbembesi
Umguza, Matebeleland North, Zimbabwe
Chamnangana
Beitbridge, Matebeleland South, Zimbabwe
Zezani
Beitbridge, Matebeleland South, Zimbabwe
Huwana RHC
Bulilima, Matebeleland South, Zimbabwe
Madlambudzi
Bulilima, Matebeleland South, Zimbabwe
Mzimuni
Gwanda, Matebeleland South, Zimbabwe
West Nicholson Zimcare
Gwanda, Matebeleland South, Zimbabwe
Sanale RHC
Insiza, Matebeleland South, Zimbabwe
Zhulube
Insiza, Matebeleland South, Zimbabwe
Dingimuzi
Mangwe, Matebeleland South, Zimbabwe
Kezi
Matobo, Matebeleland South, Zimbabwe
Matopo Hospital
Matobo, Matebeleland South, Zimbabwe
Hlangano
Umzingwane, Matebeleland South, Zimbabwe
Sponsors and Collaborators
WHO, Department of Maternal, Newborn, Child and Adolescent Health
Canadian International Development Agency
Netherlands: Ministry of Health, Welfare and Sports
Investigators
Principal Investigator: Alexio Mangwiro Clinton Health Access Initiative, Nigeria
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: WHO, Department of Maternal, Newborn, Child and Adolescent Health
ClinicalTrials.gov Identifier: NCT02070900     History of Changes
Other Study ID Numbers: WHOCHAIZIMBABWE-001 
Study First Received: February 18, 2014
Last Updated: February 20, 2014
Health Authority: Canada: Canadian International Development Agency
Switzerland: World Health Organization
Zimbabwe: World Health Organization
United States: Clinton Health Access Initiative

Keywords provided by WHO, Department of Maternal, Newborn, Child and Adolescent Health:
Prevention of Mother to Child Transmission
PMTCT
Option B+
ART
Retention
Loss to Follow Up
Time to initiation
POC CD4
Clinical mentoring
Costing
HIV
AIDS
Zimbabwe

ClinicalTrials.gov processed this record on December 06, 2016