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| Name | Class |
|---|---|
| Canadian International Development Agency | OTHER_GOV |
| Netherlands: Ministry of Health, Welfare and Sports | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | 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 | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POC CD4 | Device | Point of Care device for CD4 count testing (to be used as a clinical monitoring tool) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Proportion of HIV positive pregnant women that are retained on ART, 12 months after initiation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Retention at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexio Z Mangwiro | Contact | amangwiro@clintonhealthaccess.org |
| Name | Affiliation | Role |
|---|---|---|
| Alexio Mangwiro | Clinton Health Access Initiative, Nigeria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bromley | Recruiting | Goromonzi | Mashonaland East Province | Zimbabwe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28498190 | Derived | 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. | |
| 28498189 |
| Label | URL |
|---|---|
| CHAI website | View source |
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| Programmatic Mentoring | Other | Programmatic Mentoring aimed at messaging around CD4 count to encourage retention on lifelong ART for PMTCT patients, administered by trained clinical mentors |
|
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 |
| 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 |
| Cost per pregnant woman retained on ART | 6 months , 12 months |
| Initiation within 1 month | Proportion of HIV positive pregnant women initiating ART within 1 month of positive HIV test | 1 month |
| Henry John Rheimer | Recruiting | Goromonzi | Mashonaland East Province | Zimbabwe |
|
| Kubatsirana | Recruiting | Goromonzi | Mashonaland East Province | Zimbabwe |
|
| Melfort | Recruiting | Goromonzi | Mashonaland East Province | Zimbabwe |
|
| Mwanza RHC | Recruiting | Goromonzi | Mashonaland East Province | Zimbabwe |
|
| Border Church RHC | Recruiting | Marondera | Mashonaland East Province | Zimbabwe |
|
| Chipararwe | Recruiting | Marondera | Mashonaland East Province | Zimbabwe |
|
| Lustleigh | Recruiting | Marondera | Mashonaland East Province | Zimbabwe |
|
| Masikana | Recruiting | Marondera | Mashonaland East Province | Zimbabwe |
|
| Charehwa | Recruiting | Mutoko | Mashonaland East Province | Zimbabwe |
|
| Kushinga RHC | Recruiting | Mutoko | Mashonaland East Province | Zimbabwe |
|
| Nyamazuwe Rural Hospital | Recruiting | Mutoko | Mashonaland East Province | Zimbabwe |
|
| Masasa | Recruiting | Seki | Mashonaland East Province | Zimbabwe |
|
| Mashambanhaka | Recruiting | UMP | Mashonaland East Province | Zimbabwe |
|
| Mdutshane RHC | Recruiting | Bubi | Matebeleland North | Zimbabwe |
|
| Membeswana RHC | Recruiting | Bubi | Matebeleland North | Zimbabwe |
|
| Lupaka | Recruiting | Lupane | Matebeleland North | Zimbabwe |
|
| Madlangombe | Recruiting | Tsholotsho | Matebeleland North | Zimbabwe |
| Makhaza RHC | Recruiting | Tsholotsho | Matebeleland North | Zimbabwe |
| Mbembesi | Recruiting | Umguza Estate | Matebeleland North | Zimbabwe |
|
| Chamnangana | Recruiting | Beitbridge | Matebeleland South | Zimbabwe |
|
| Zezani | Recruiting | Beitbridge | Matebeleland South | Zimbabwe |
|
| Huwana RHC | Recruiting | Bulilima | Matebeleland South | Zimbabwe |
|
| Madlambudzi | Recruiting | Bulilima | Matebeleland South | Zimbabwe |
|
| Mzimuni | Recruiting | Gwanda | Matebeleland South | Zimbabwe |
|
| West Nicholson Zimcare | Recruiting | Gwanda | Matebeleland South | Zimbabwe |
|
| Sanale RHC | Recruiting | Insiza | Matebeleland South | Zimbabwe |
|
| Zhulube | Recruiting | Insiza | Matebeleland South | Zimbabwe |
|
| Dingimuzi | Recruiting | Mangwe | Matebeleland South | Zimbabwe |
|
| Kezi | Recruiting | Matopos | Matebeleland South | Zimbabwe |
|
| Matopo Hospital | Recruiting | Matopos | Matebeleland South | Zimbabwe |
|
| Hlangano | Recruiting | Umzingwane | Matebeleland South | Zimbabwe |
|
| Derived |
| 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. |
| 25310120 | Derived | 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. |
| INSPIRE Initiative page | View source |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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