Clinical trial NCT00931216: Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya
Official title: Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: PMTCT
Vertical transmission of HIV
Pregnant women
Infant HIV testing
Kenya
AIDS
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Kenya Medical Research Institute
First posted: 2009-07-02
Enrollment: 1172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* FOR SITE INCLUSION:

  * Each site must provide ANC services
  * Each site must provide HIV testing services for pregnant women
  * Each site must have an average of at least 20 new ANC clients per month
* FOR ENROLLMENT OF HIV-POSITIVE WOMEN:

  * All women testing HIV-positive at one of the 12 ANC clinics included in the study will be asked to participate in the study
* FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:

  * Health care staff must work within the ANC clinic at selected facilities
  * Staff must be able to read and speak English well enough to complete the informed consent process, participate in a one-on-one in-depth interview in English and complete a brief self-administered questionnaire

Exclusion Criteria:

* FOR SITE EXCLUSION:

  * If all of inclusion criteria are not met the site will be excluded
  * If site is already providing integrated ANC/HIV care services
* FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:

  * If all of inclusion criteria are not met the site will be excluded

Primary outcomes:
measure: Vertical transmission of HIV
timeFrame: 3 months postpartum
Secondary outcomes:
measure: Maternal HIV treatment outcomes
timeFrame: 6 months, 1 year
measure: Provider job satisfaction
timeFrame: 1 year
measure: Infant HIV testing uptake
timeFrame: 3 months postpartum
measure: Patient enrollment, retention and adherence in HIV care and treatment
timeFrame: 6 months, 1 year
Other outcomes:
Locations:
city: Migori
country: Kenya
facility: Migori District Hospital
Study officials:
affiliation: University of California, San Francisco
name: Craig R Cohen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Janet M Turan, PhD, MPH
role: STUDY_DIRECTOR
affiliation: Kenya Medical Research Institute
name: Elizabeth A Bukusi, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.