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
  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

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

Contacts
Contact: Alexio Z Mangwiro amangwiro@clintonhealthaccess.org

Locations
Zimbabwe
Bromley Recruiting
Goromonzi, Mashonaland East, Zimbabwe
Contact: Adam Muchenje, RGN    0712960915      
Henry John Rheimer Recruiting
Goromonzi, Mashonaland East, Zimbabwe
Contact: B Deve, RGN    0772697621      
Kubatsirana Recruiting
Goromonzi, Mashonaland East, Zimbabwe
Contact: Mamboininga, RGN    0772689582      
Melfort Recruiting
Goromonzi, Mashonaland East, Zimbabwe
Contact: A Maburunje, RGN    0772515932      
Mwanza RHC Recruiting
Goromonzi, Mashonaland East, Zimbabwe
Contact: Dabion Viano, SCN    0774432464      
Border Church RHC Recruiting
Marondera, Mashonaland East, Zimbabwe
Contact: Justice Mulungisi, RGN    0776424031      
Chipararwe Recruiting
Marondera, Mashonaland East, Zimbabwe
Contact: C Machiridza, RGN    0772686618      
Lustleigh Recruiting
Marondera, Mashonaland East, Zimbabwe
Contact: Esther Madzande, SCN    0772319999      
Masikana Recruiting
Marondera, Mashonaland East, Zimbabwe
Contact: C Bvute    0774568610      
Charehwa Recruiting
Mutoko, Mashonaland East, Zimbabwe
Contact: L Muntimwa, PCN    0773752469      
Kushinga RHC Recruiting
Mutoko, Mashonaland East, Zimbabwe
Contact: M Mauyangwe, RGN    0772521241      
Nyamazuwe Rural Hospital Recruiting
Mutoko, Mashonaland East, Zimbabwe
Contact: Freddy Chengo, PCN    0773545616      
Masasa Recruiting
Seke, Mashonaland East, Zimbabwe
Contact: Eveline Mhlanga, PCN    0775417634      
Mashambanhaka Recruiting
UMP, Mashonaland East, Zimbabwe
Contact: I Katsande, PCN    0774000155      
Mdutshane RHC Recruiting
Bubi, Matebeleland North, Zimbabwe
Contact    0712954518      
Membeswana RHC Recruiting
Bubi, Matebeleland North, Zimbabwe
Contact: , CHN    0772953292      
Lupaka Recruiting
Lupane, Matebeleland North, Zimbabwe
Contact: Musa Gumbo, PCN    0715327222      
Madlangombe Recruiting
Tsholotsho, Matebeleland North, Zimbabwe
Makhaza RHC Recruiting
Tsholotsho, Matebeleland North, Zimbabwe
Mbembesi Recruiting
Umguza, Matebeleland North, Zimbabwe
Contact: Mpilo Moyo, PCN    0712303818      
Chamnangana Recruiting
Beitbridge, Matebeleland South, Zimbabwe
Contact: Willard Sibonginkosi, PCN    0774703830      
Zezani Recruiting
Beitbridge, Matebeleland South, Zimbabwe
Contact: Gertrude Mbedzi, PCN    0774704367      
Huwana RHC Recruiting
Bulilima, Matebeleland South, Zimbabwe
Contact: Samkeliso Gonde, PCN    0777755858      
Madlambudzi Recruiting
Bulilima, Matebeleland South, Zimbabwe
Contact: Sithandwa Sitole, PCN    0774566310      
Mzimuni Recruiting
Gwanda, Matebeleland South, Zimbabwe
Contact: A Moyo, PCN    0772476328      
West Nicholson Zimcare Recruiting
Gwanda, Matebeleland South, Zimbabwe
Contact: Mugadziri Shoko, PCN    0776482393      
Sanale RHC Recruiting
Insiza, Matebeleland South, Zimbabwe
Contact: Zenele Ncube, PCN    0712567761      
Zhulube Recruiting
Insiza, Matebeleland South, Zimbabwe
Contact: P Twala, PCN    0712947820      
Dingimuzi Recruiting
Mangwe, Matebeleland South, Zimbabwe
Contact    0773878931      
Kezi Recruiting
Matobo, Matebeleland South, Zimbabwe
Contact: Lawrence Ndlovu, RGN    0735613724      
Matopo Hospital Recruiting
Matobo, Matebeleland South, Zimbabwe
Contact: Cornwell Sibanda, RGN    0713986064      
Hlangano Recruiting
Umzingwane, Matebeleland South, Zimbabwe
Contact: Davison Nkala, RGN    0772997372      
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:
No publications provided

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
HIV
Option B+
ART
Retention
Loss to Follow Up
Time to initiation
POC CD4
Clinical mentoring
Costing
AIDS
Zimbabwe

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014