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AzTrials

HIV/AIDSE4ENCT02070900

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?

A study testing POC CD4 and Programmatic Mentoring in people with HIV/AIDS, run by WHO, Department of Maternal, Newborn, Child and Adolescent Health at 32 sites in Zimbabwe.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
POC CD4 and Programmatic Mentoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
704 participants
Where
32 sitesZimbabwe
Study dates
Jan 2014to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Already on ART at booking
  • Presents more than 38 weeks into gestation or less than 48 hours prior to delivery

Trial locations and contacts

32 sites in 1 country.

Alexio Z Mangwiro contact

amangwiro@clintonhealthaccess.org

32 sites in 1 country

Zimbabwe32 sites, 32 recruiting

  • Chamnangana

    Beitbridge, Matebeleland South

    Willard Sibonginkosi, PCN, 0774703830

    Recruiting

  • Zezani

    Beitbridge, Matebeleland South

    Gertrude Mbedzi, PCN, 0774704367

    Recruiting

  • Mdutshane RHC

    Bubi, Matebeleland North

    0712954518

    Recruiting

  • Membeswana RHC

    Bubi, Matebeleland North

    CHN, 0772953292

    Recruiting

  • Huwana RHC

    Bulilima, Matebeleland South

    Samkeliso Gonde, PCN, 0777755858

    Recruiting

  • Madlambudzi

    Bulilima, Matebeleland South

    Sithandwa Sitole, PCN, 0774566310

    Recruiting

  • Bromley

    Goromonzi, Mashonaland East Province

    Adam Muchenje, RGN, 0712960915

    Recruiting

  • Henry John Rheimer

    Goromonzi, Mashonaland East Province

    B Deve, RGN, 0772697621

    Recruiting

  • Kubatsirana

    Goromonzi, Mashonaland East Province

    Mamboininga, RGN, 0772689582

    Recruiting

  • Melfort

    Goromonzi, Mashonaland East Province

    A Maburunje, RGN, 0772515932

    Recruiting

  • Mwanza RHC

    Goromonzi, Mashonaland East Province

    Dabion Viano, SCN, 0774432464

    Recruiting

  • Mzimuni

    Gwanda, Matebeleland South

    A Moyo, PCN, 0772476328

    Recruiting

  • West Nicholson Zimcare

    Gwanda, Matebeleland South

    Mugadziri Shoko, PCN, 0776482393

    Recruiting

  • Sanale RHC

    Insiza, Matebeleland South

    Zenele Ncube, PCN, 0712567761

    Recruiting

  • Zhulube

    Insiza, Matebeleland South

    P Twala, PCN, 0712947820

    Recruiting

  • Lupaka

    Lupane, Matebeleland North

    Musa Gumbo, PCN, 0715327222

    Recruiting

  • Dingimuzi

    Mangwe, Matebeleland South

    0773878931

    Recruiting

  • Border Church RHC

    Marondera, Mashonaland East Province

    Justice Mulungisi, RGN, 0776424031

    Recruiting

  • Chipararwe

    Marondera, Mashonaland East Province

    C Machiridza, RGN, 0772686618

    Recruiting

  • Lustleigh

    Marondera, Mashonaland East Province

    Esther Madzande, SCN, 0772319999

    Recruiting

  • Masikana

    Marondera, Mashonaland East Province

    C Bvute, 0774568610

    Recruiting

  • Kezi

    Matopos, Matebeleland South

    Lawrence Ndlovu, RGN, 0735613724

    Recruiting

  • Matopo Hospital

    Matopos, Matebeleland South

    Cornwell Sibanda, RGN, 0713986064

    Recruiting

  • Charehwa

    Mutoko, Mashonaland East Province

    L Muntimwa, PCN, 0773752469

    Recruiting

  • Kushinga RHC

    Mutoko, Mashonaland East Province

    M Mauyangwe, RGN, 0772521241

    Recruiting

  • Nyamazuwe Rural Hospital

    Mutoko, Mashonaland East Province

    Freddy Chengo, PCN, 0773545616

    Recruiting

  • Masasa

    Seki, Mashonaland East Province

    Eveline Mhlanga, PCN, 0775417634

    Recruiting

  • Madlangombe

    Tsholotsho, Matebeleland North

    Recruiting

  • Makhaza RHC

    Tsholotsho, Matebeleland North

    Recruiting

  • Mbembesi

    Umguza Estate, Matebeleland North

    Mpilo Moyo, PCN, 0712303818

    Recruiting

  • Mashambanhaka

    UMP, Mashonaland East Province

    I Katsande, PCN, 0774000155

    Recruiting

  • Hlangano

    Umzingwane, Matebeleland South

    Davison Nkala, RGN, 0772997372

    Recruiting

Other trials in Zimbabwe

About this study

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
HIV/AIDS
Being tested
POC CD4, Programmatic Mentoring
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
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • POC CD4Device

    Also called Alere PIMA

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

  • Programmatic MentoringOther

    Programmatic Mentoring aimed at messaging around CD4 count to encourage retention on lifelong ART for PMTCT patients, administered by trained clinical mentors

Study groups in NCT02070900
Study groupRoleWhat they receive
Standard of CareNo interventionSites 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 PlusExperimentalSites 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
Receives: Device: POC CD4; Other: Programmatic Mentoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention

    Proportion of HIV positive pregnant women that are retained on ART, 12 months after initiation

    Measured: 12 months

Secondary outcomes (5)

  1. 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

    Measured: 12 months

  2. 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

    Measured: 6 months

  3. 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

    Measured: 6 months , 12 months

  4. Cost per pregnant woman retained on ART

    Measured: 6 months , 12 months

  5. Initiation within 1 month

    Proportion of HIV positive pregnant women initiating ART within 1 month of positive HIV test

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJun 2015 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
704 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02070900
Sponsor's protocol ID
WHOCHAIZIMBABWE-001
Acronym
E4E
Status last verified
Feb 2014
First submitted
18 Feb 2014
Last updated
25 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28498190

  • 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.

    PubMed 28498189

  • 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.

    PubMed 25310120

Questions about this trial

What is this clinical trial studying?

A study testing POC CD4 and Programmatic Mentoring in people with HIV/AIDS, run by WHO, Department of Maternal, Newborn, Child and Adolescent Health at 32 sites in Zimbabwe.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alexio Z Mangwiro (amangwiro@clintonhealthaccess.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02070900, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.

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