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)

February 20, 2014 updated by: WHO, Department of Maternal, Newborn, Child and Adolescent Health

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

704

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
    • Mashonaland East
      • Goromonzi, Mashonaland East, Zimbabwe
        • Recruiting
        • Bromley
        • Contact:
          • Adam Muchenje, RGN
          • Phone Number: 0712960915
      • Goromonzi, Mashonaland East, Zimbabwe
        • Recruiting
        • Henry John Rheimer
        • Contact:
          • B Deve, RGN
          • Phone Number: 0772697621
      • Goromonzi, Mashonaland East, Zimbabwe
        • Recruiting
        • Kubatsirana
        • Contact:
          • Mamboininga, RGN
          • Phone Number: 0772689582
      • Goromonzi, Mashonaland East, Zimbabwe
        • Recruiting
        • Melfort
        • Contact:
          • A Maburunje, RGN
          • Phone Number: 0772515932
      • Goromonzi, Mashonaland East, Zimbabwe
        • Recruiting
        • Mwanza RHC
        • Contact:
          • Dabion Viano, SCN
          • Phone Number: 0774432464
      • Marondera, Mashonaland East, Zimbabwe
        • Recruiting
        • Border Church RHC
        • Contact:
          • Justice Mulungisi, RGN
          • Phone Number: 0776424031
      • Marondera, Mashonaland East, Zimbabwe
        • Recruiting
        • Chipararwe
        • Contact:
          • C Machiridza, RGN
          • Phone Number: 0772686618
      • Marondera, Mashonaland East, Zimbabwe
        • Recruiting
        • Lustleigh
        • Contact:
          • Esther Madzande, SCN
          • Phone Number: 0772319999
      • Marondera, Mashonaland East, Zimbabwe
        • Recruiting
        • Masikana
        • Contact:
          • C Bvute
          • Phone Number: 0774568610
      • Mutoko, Mashonaland East, Zimbabwe
        • Recruiting
        • Charehwa
        • Contact:
          • L Muntimwa, PCN
          • Phone Number: 0773752469
      • Mutoko, Mashonaland East, Zimbabwe
        • Recruiting
        • Kushinga RHC
        • Contact:
          • M Mauyangwe, RGN
          • Phone Number: 0772521241
      • Mutoko, Mashonaland East, Zimbabwe
        • Recruiting
        • Nyamazuwe Rural Hospital
        • Contact:
          • Freddy Chengo, PCN
          • Phone Number: 0773545616
      • Seke, Mashonaland East, Zimbabwe
        • Recruiting
        • Masasa
        • Contact:
          • Eveline Mhlanga, PCN
          • Phone Number: 0775417634
      • UMP, Mashonaland East, Zimbabwe
        • Recruiting
        • Mashambanhaka
        • Contact:
          • I Katsande, PCN
          • Phone Number: 0774000155
    • Matebeleland North
      • Bubi, Matebeleland North, Zimbabwe
        • Recruiting
        • Mdutshane RHC
        • Contact:
          • Phone Number: 0712954518
      • Bubi, Matebeleland North, Zimbabwe
        • Recruiting
        • Membeswana RHC
        • Contact:
          • CHN
          • Phone Number: 0772953292
      • Lupane, Matebeleland North, Zimbabwe
        • Recruiting
        • Lupaka
        • Contact:
          • Musa Gumbo, PCN
          • Phone Number: 0715327222
      • Tsholotsho, Matebeleland North, Zimbabwe
        • Recruiting
        • Madlangombe
      • Tsholotsho, Matebeleland North, Zimbabwe
        • Recruiting
        • Makhaza RHC
      • Umguza, Matebeleland North, Zimbabwe
        • Recruiting
        • Mbembesi
        • Contact:
          • Mpilo Moyo, PCN
          • Phone Number: 0712303818
    • Matebeleland South
      • Beitbridge, Matebeleland South, Zimbabwe
        • Recruiting
        • Chamnangana
        • Contact:
          • Willard Sibonginkosi, PCN
          • Phone Number: 0774703830
      • Beitbridge, Matebeleland South, Zimbabwe
        • Recruiting
        • Zezani
        • Contact:
          • Gertrude Mbedzi, PCN
          • Phone Number: 0774704367
      • Bulilima, Matebeleland South, Zimbabwe
        • Recruiting
        • Huwana RHC
        • Contact:
          • Samkeliso Gonde, PCN
          • Phone Number: 0777755858
      • Bulilima, Matebeleland South, Zimbabwe
        • Recruiting
        • Madlambudzi
        • Contact:
          • Sithandwa Sitole, PCN
          • Phone Number: 0774566310
      • Gwanda, Matebeleland South, Zimbabwe
        • Recruiting
        • Mzimuni
        • Contact:
          • A Moyo, PCN
          • Phone Number: 0772476328
      • Gwanda, Matebeleland South, Zimbabwe
        • Recruiting
        • West Nicholson Zimcare
        • Contact:
          • Mugadziri Shoko, PCN
          • Phone Number: 0776482393
      • Insiza, Matebeleland South, Zimbabwe
        • Recruiting
        • Sanale RHC
        • Contact:
          • Zenele Ncube, PCN
          • Phone Number: 0712567761
      • Insiza, Matebeleland South, Zimbabwe
        • Recruiting
        • Zhulube
        • Contact:
          • P Twala, PCN
          • Phone Number: 0712947820
      • Mangwe, Matebeleland South, Zimbabwe
        • Recruiting
        • Dingimuzi
        • Contact:
          • Phone Number: 0773878931
      • Matobo, Matebeleland South, Zimbabwe
        • Recruiting
        • Kezi
        • Contact:
          • Lawrence Ndlovu, RGN
          • Phone Number: 0735613724
      • Matobo, Matebeleland South, Zimbabwe
        • Recruiting
        • Matopo Hospital
        • Contact:
          • Cornwell Sibanda, RGN
          • Phone Number: 0713986064
      • Umzingwane, Matebeleland South, Zimbabwe
        • Recruiting
        • Hlangano
        • Contact:
          • Davison Nkala, RGN
          • Phone Number: 0772997372

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: 12 months
Proportion of HIV positive pregnant women that are retained on ART, 12 months after initiation
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
6 months
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
6 months , 12 months
Cost per pregnant woman retained on ART
Time Frame: 6 months , 12 months
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Netherlands: Ministry of Health, Welfare and Sports
Canadian International Development Agency

Investigators

  • Principal Investigator: Alexio Mangwiro, Clinton Health Access Initiative, Nigeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 25, 2014

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WHOCHAIZIMBABWE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV/AIDS

Clinical Trials on POC CD4

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe