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?

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02070900
• Date of registration: 18/02/2014
• Prospective Registration: No
• Primary sponsor: WHO, Department of Maternal, Newborn, Child and Adolescent Health
• Public 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? E4E
• Scientific 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?
• Date of first enrolment: January 2014
• Target sample size: 704
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02070900
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Zimbabwe

Contacts

• Name: Alexio Mangwiro
• Affiliation: Clinton Health Access Initiative, Nigeria

• Name: Alexio Z Mangwiro

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

HIV/AIDS

Intervention(s)

Device: POC CD4

Other: Programmatic Mentoring

Primary Outcome(s)

Retention [Time Frame: 12 months]

Secondary Outcome(s)

Retention by CD4 count [Time Frame: 6 months , 12 months]

Cost per pregnant woman retained on ART [Time Frame: 6 months , 12 months]

Initiation within 1 month [Time Frame: 1 month]

Retention at 6 months [Time Frame: 6 months]

Time-to-initiation [Time Frame: 12 months]

Secondary ID(s)

WHOCHAIZIMBABWE-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Canadian International Development Agency

Netherlands: Ministry of Health, Welfare and Sports