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)

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

Status: Unknown

Conditions: HIV/AIDS

Treatments: Device: POC CD4; Other: Programmatic Mentoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02070900

WHOCHAIZIMBABWE-001

Details and patient eligibility

About

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.

Enrollment: 704 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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704 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

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

POC Plus

Experimental group

Description:

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

Treatment:

Other: Programmatic Mentoring

Device: POC CD4