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?

HIV/AIDS Clinical Trial

— E4E  

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02070900
• Other study ID #: WHOCHAIZIMBABWE-001
• Status: Recruiting
• Phase: N/A
• First received: February 18, 2014
• Last updated: February 20, 2014
• Start date: January 2014
• Est. completion date: July 2016

Study information

• Verified date: February 2014
• Source: WHO, Department of Maternal, Newborn, Child and Adolescent Health
• Contact: Alexio Z Mangwiro
• Email: amangwiro[@]clintonhealthaccess.org
• Is FDA regulated: No
• Health authority: Canada: Canadian International Development AgencySwitzerland: World Health OrganizationZimbabwe: World Health OrganizationUnited States: Clinton Health Access Initiative
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 704
• Est. completion date: July 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

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

Locations

Country	Name	City	State
Zimbabwe	Chamnangana	Beitbridge	Matebeleland South
Zimbabwe	Zezani	Beitbridge	Matebeleland South
Zimbabwe	Mdutshane RHC	Bubi	Matebeleland North
Zimbabwe	Membeswana RHC	Bubi	Matebeleland North
Zimbabwe	Huwana RHC	Bulilima	Matebeleland South
Zimbabwe	Madlambudzi	Bulilima	Matebeleland South
Zimbabwe	Bromley	Goromonzi	Mashonaland East
Zimbabwe	Henry John Rheimer	Goromonzi	Mashonaland East
Zimbabwe	Kubatsirana	Goromonzi	Mashonaland East
Zimbabwe	Melfort	Goromonzi	Mashonaland East
Zimbabwe	Mwanza RHC	Goromonzi	Mashonaland East
Zimbabwe	Mzimuni	Gwanda	Matebeleland South
Zimbabwe	West Nicholson Zimcare	Gwanda	Matebeleland South
Zimbabwe	Sanale RHC	Insiza	Matebeleland South
Zimbabwe	Zhulube	Insiza	Matebeleland South
Zimbabwe	Lupaka	Lupane	Matebeleland North
Zimbabwe	Dingimuzi	Mangwe	Matebeleland South
Zimbabwe	Border Church RHC	Marondera	Mashonaland East
Zimbabwe	Chipararwe	Marondera	Mashonaland East
Zimbabwe	Lustleigh	Marondera	Mashonaland East
Zimbabwe	Masikana	Marondera	Mashonaland East
Zimbabwe	Kezi	Matobo	Matebeleland South
Zimbabwe	Matopo Hospital	Matobo	Matebeleland South
Zimbabwe	Charehwa	Mutoko	Mashonaland East
Zimbabwe	Kushinga RHC	Mutoko	Mashonaland East
Zimbabwe	Nyamazuwe Rural Hospital	Mutoko	Mashonaland East
Zimbabwe	Masasa	Seke	Mashonaland East
Zimbabwe	Madlangombe	Tsholotsho	Matebeleland North
Zimbabwe	Makhaza RHC	Tsholotsho	Matebeleland North
Zimbabwe	Mbembesi	Umguza	Matebeleland North
Zimbabwe	Mashambanhaka	UMP	Mashonaland East
Zimbabwe	Hlangano	Umzingwane	Matebeleland South

Sponsors (3)

Lead Sponsor	Collaborator
WHO, Department of Maternal, Newborn, Child and Adolescent Health	Canadian International Development Agency, Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Proportion of HIV positive pregnant women that are retained on ART, 12 months after initiation	12 months	No
Secondary	Time-to-initiation	Median time-to-initiation between HIV positive diagnosis and enrolment onto Option B+ with or without POC CD4 and related counseling/support	12 months	No
Secondary	Retention at 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	No
Secondary	Retention by CD4 count	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	No
Secondary	Cost per pregnant woman retained on ART		6 months , 12 months	No
Secondary	Initiation within 1 month	Proportion of HIV positive pregnant women initiating ART within 1 month of positive HIV test	1 month	No

External Links

•   CHAI website
•   INSPIRE Initiative page