Clinical Trials

MainTitle

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.

Verified February 2014 by WHO, Department of Maternal, Newborn, Child and Adolescent Health

Sponsor
WHO, Department of Maternal, Newborn, Child and Adolescent Health

Collaborator
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
History of Changes
Purpose

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: None (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?

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

Primary Outcome Measures

  • Retention [ Time Frame: 12 months ]
    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 ]
    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 ]
    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 ]
    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 ]
  • Initiation within 1 month [ Time Frame: 1 month ]
    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

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes 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

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

More Information

Additional Information:

CHAI website

Additional Information:

INSPIRE Initiative page

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  

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

Additional relevant MeSH terms:
HIV Seropositivity

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.