Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| Kenya Medical Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study seeks to determine the most effective way to reach and provide pregnant women with accessible, comprehensive, and high quality HIV care and treatment.
This study uses a prospective cluster randomized design. Twelve clinics similar in size, population, and services in Migori district, Kenya that provide ANC have been randomly assigned to receive "integrated ANC, PMTCT & HIV services" (intervention arm) or "non-integrated services" (control arm). At the intervention clinics, pregnant women will receive ANC, PMTCT and HIV care and treatment (including HAART if required) at the same clinic visit from the ANC provider. At the control clinics, women will receive antenatal care and PMTCT services with referral to the HIV care and treatment department located in the same facility. The control sites more closely resemble the current approach followed for care and treatment of HIV-infected pregnant women in Kenya. The content of ANC, PMTCT, and HIV care will be the same in the two study arms and will follow current Kenyan national guidelines. The only difference between the two arms will be the provider/location of HIV care and treatment.
Outcomes will be compared for HIV-positive pregnant women who attend intervention versus control facilities. In addition we will conduct qualitative research with health care providers at the study health facilities in order to learn provider perspectives on the two service models and to explore the effects of integration on provider job satisfaction (including work load).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated ANC, PMTCT and HIV Services | Experimental | HIV care and treatment services are integrated into antenatal care (ANC) services for women testing positive within the ANC at this facility. |
|
| Non-Integrated Services | No Intervention | Women testing positive in the ANC department are referred for care at the HIV clinic. HIV care and treatment services are not provided within the ANC at facilities randomized to this arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated ANC, PMTCT, HIV services | Procedure | Of the 12 study clinics, 6 will be randomized to receive the intervention. At these 6 facilities, health care providers within the ANC department will be trained to also provide HIV/PMTCT care. Women testing positive within ANC clinics at integrated facilities will receive ANC, PMTCT and HIV services within the same visit/same service provider rather than being referred for HIV care and treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Vertical transmission of HIV | 3 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal HIV treatment outcomes | 6 months, 1 year | |
| Provider job satisfaction | 1 year | |
| Infant HIV testing uptake |
Not provided
Inclusion Criteria:
FOR SITE INCLUSION:
FOR ENROLLMENT OF HIV-POSITIVE WOMEN:
FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:
Exclusion Criteria:
FOR SITE EXCLUSION:
FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Craig R Cohen, MD, MPH | University of California, San Francisco | Principal Investigator |
| Janet M Turan, PhD, MPH | University of California, San Francisco | Study Director |
| Elizabeth A Bukusi, MBChB, PhD | Kenya Medical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Migori District Hospital | Migori | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22970177 | Derived | Turan JM, Steinfeld RL, Onono M, Bukusi EA, Woods M, Shade SB, Washington S, Marima R, Penner J, Ackers ML, Mbori-Ngacha D, Cohen CR. The study of HIV and antenatal care integration in pregnancy in Kenya: design, methods, and baseline results of a cluster-randomized controlled trial. PLoS One. 2012;7(9):e44181. doi: 10.1371/journal.pone.0044181. Epub 2012 Sep 6. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 3 months postpartum |
| Patient enrollment, retention and adherence in HIV care and treatment | 6 months, 1 year |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |