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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?

NCT02070900 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 704

Last updated 2014-02-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

POC CD4

Point of Care device for CD4 count testing (to be used as a clinical monitoring tool)

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

Sponsors & Collaborators

  • Canadian International Development Agency

    collaborator OTHER_GOV

  • Netherlands: Ministry of Health, Welfare and Sports

    collaborator OTHER_GOV

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

    lead OTHER

Principal Investigators

  • Alexio Mangwiro · Clinton Health Access Initiative, Nigeria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-06-30
Completion
2016-07-31

Countries

  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02070900 on ClinicalTrials.gov