Clinical trial NCT02070900: 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?
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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV/AIDS
Keywords: Prevention of Mother to Child Transmission
PMTCT
Option B+
ART
Retention
Loss to Follow Up
Time to initiation
POC CD4
Clinical mentoring
Costing
HIV
AIDS
Zimbabwe
Lead sponsor: WHO, Department of Maternal, Newborn, Child and Adolescent Health
Sponsor class: OTHER
Collaborators: name: Canadian International Development Agency
name: Netherlands: Ministry of Health, Welfare and Sports
First posted: 2014-02-25
Enrollment: 704
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Retention
timeFrame: 12 months
Secondary outcomes:
measure: Time-to-initiation
timeFrame: 12 months
measure: Retention at 6 months
timeFrame: 6 months
measure: Retention by CD4 count
timeFrame: 6 months , 12 months
measure: Cost per pregnant woman retained on ART
timeFrame: 6 months , 12 months
measure: Initiation within 1 month
timeFrame: 1 month
Other outcomes:
Locations:
city: Goromonzi
country: Zimbabwe
facility: Bromley
state: Mashonaland East
city: Goromonzi
country: Zimbabwe
facility: Henry John Rheimer
state: Mashonaland East
city: Goromonzi
country: Zimbabwe
facility: Kubatsirana
state: Mashonaland East
city: Goromonzi
country: Zimbabwe
facility: Melfort
state: Mashonaland East
city: Goromonzi
country: Zimbabwe
facility: Mwanza RHC
state: Mashonaland East
city: Marondera
country: Zimbabwe
facility: Border Church RHC
state: Mashonaland East
city: Marondera
country: Zimbabwe
facility: Chipararwe
state: Mashonaland East
city: Marondera
country: Zimbabwe
facility: Lustleigh
state: Mashonaland East
city: Marondera
country: Zimbabwe
facility: Masikana
state: Mashonaland East
city: Mutoko
country: Zimbabwe
facility: Charehwa
state: Mashonaland East
city: Mutoko
country: Zimbabwe
facility: Kushinga RHC
state: Mashonaland East
city: Mutoko
country: Zimbabwe
facility: Nyamazuwe Rural Hospital
state: Mashonaland East
city: Seke
country: Zimbabwe
facility: Masasa
state: Mashonaland East
city: UMP
country: Zimbabwe
facility: Mashambanhaka
state: Mashonaland East
city: Bubi
country: Zimbabwe
facility: Mdutshane RHC
state: Matebeleland North
city: Bubi
country: Zimbabwe
facility: Membeswana RHC
state: Matebeleland North
city: Lupane
country: Zimbabwe
facility: Lupaka
state: Matebeleland North
city: Tsholotsho
country: Zimbabwe
facility: Madlangombe
state: Matebeleland North
city: Tsholotsho
country: Zimbabwe
facility: Makhaza RHC
state: Matebeleland North
city: Umguza
country: Zimbabwe
facility: Mbembesi
state: Matebeleland North
city: Beitbridge
country: Zimbabwe
facility: Chamnangana
state: Matebeleland South
city: Beitbridge
country: Zimbabwe
facility: Zezani
state: Matebeleland South
city: Bulilima
country: Zimbabwe
facility: Huwana RHC
state: Matebeleland South
city: Bulilima
country: Zimbabwe
facility: Madlambudzi
state: Matebeleland South
city: Gwanda
country: Zimbabwe
facility: Mzimuni
state: Matebeleland South
city: Gwanda
country: Zimbabwe
facility: West Nicholson Zimcare
state: Matebeleland South
city: Insiza
country: Zimbabwe
facility: Sanale RHC
state: Matebeleland South
city: Insiza
country: Zimbabwe
facility: Zhulube
state: Matebeleland South
city: Mangwe
country: Zimbabwe
facility: Dingimuzi
state: Matebeleland South
city: Matobo
country: Zimbabwe
facility: Kezi
state: Matebeleland South
city: Matobo
country: Zimbabwe
facility: Matopo Hospital
state: Matebeleland South
city: Umzingwane
country: Zimbabwe
facility: Hlangano
state: Matebeleland South
Study officials:
affiliation: Clinton Health Access Initiative, Nigeria
name: Alexio Mangwiro
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erlwanger AS, Joseph J, Gotora T, Muzunze B, Orne-Gliemann J, Mukungunugwa S, Farley T, Mangwiro AZ. Patterns of HIV Care Clinic Attendance and Adherence to Antiretroviral Therapy Among Pregnant and Breastfeeding Women Living With HIV in the Context of Option B+ in Zimbabwe. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S198-S206. doi: 10.1097/QAI.0000000000001347.
citation: Joseph J, Gotora T, Erlwanger AS, Mushavi A, Zizhou S, Masuka N, Boeke CE, Mangwiro AZ. Impact of Point-of-Care CD4 Testing on Retention in Care Among HIV-Positive Pregnant and Breastfeeding Women in the Context of Option B+ in Zimbabwe: A Cluster Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S190-S197. doi: 10.1097/QAI.0000000000001341.
citation: Mangwiro AZ, Makomva K, Bhattacharya A, Bhattacharya G, Gotora T, Owen M, Mushavi A, Mangwanya D, Zinyowera S, Rusakaniko S, Mugurungi O, Zizhou S, Busumani W, Masuka N. Does provision of point-of-care CD4 technology and early knowledge of CD4 levels affect early initiation and retention on antiretroviral treatment in HIV-positive pregnant women in the context of Option B+ for PMTCT? J Acquir Immune Defic Syndr. 2014 Nov 1;67 Suppl 2:S139-44. doi: 10.1097/QAI.0000000000000326.