HIV InfectionsNCT00931216
Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya
A study testing Integrated ANC, PMTCT, HIV services in people with HIV Infections, run by University of California, San Francisco at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Integrated ANC, PMTCT, HIV services
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,172 participants
- Where
- 1 siteKenya
- Study dates
- Jun 2009to Mar 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- HIV Infections
- Being tested
- Integrated ANC, PMTCT, HIV services
- Keywords
- PMTCT, Vertical transmission of HIV, Pregnant women, Infant HIV testing, Kenya, AIDS
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated ANC, PMTCT, HIV servicesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Integrated ANC, PMTCT, HIV services |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical transmission of HIV
Measured: 3 months postpartum
Secondary outcomes (4)
Maternal HIV treatment outcomes
Measured: 6 months, 1 year
Provider job satisfaction
Measured: 1 year
Infant HIV testing uptake
Measured: 3 months postpartum
Patient enrollment, retention and adherence in HIV care and treatment
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Kenya Medical Research Institute
- Responsible party
- Principal investigator, Craig Cohen, University of California, San Francisco
- Investigators
- Craig R Cohen, MD, MPH, Principal investigator, University of California, San FranciscoJanet M Turan, PhD, MPH, Study director, University of California, San FranciscoElizabeth A Bukusi, MBChB, PhD, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931216
- Sponsor's protocol ID
- KE.07.0055
- Status last verified
- Apr 2012
- First submitted
- 30 Jun 2009
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22970177
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya
- ClinicalTrials.gov ID
- NCT00931216
- Acronym / sponsor ID
- KE.07.0055
- Conditions
- HIV Infections
- Keywords
- PMTCT, Vertical transmission of HIV, Pregnant women, Infant HIV testing, Kenya, AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,172 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Kenya Medical Research Institute
- Study start
- Jun 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated ANC, PMTCT and HIV Services | Experimental | Procedure: Integrated ANC, PMTCT, HIV servicesHIV 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- FOR SITE INCLUSION:
- FOR ENROLLMENT OF HIV-POSITIVE WOMEN:
- FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:
Key exclusion criteria (5 listed)
- FOR SITE EXCLUSION:
- FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated ANC, PMTCT, HIV servicesOf 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. | Procedure or surgery | Integrated ANC, PMTCT and HIV Services |
Primary outcome
Vertical transmission of HIV
Time frame: 3 months postpartum
4 secondary outcomes
Maternal HIV treatment outcomes
Time frame: 6 months, 1 year
Provider job satisfaction
Time frame: 1 year
Infant HIV testing uptake
Time frame: 3 months postpartum
Patient enrollment, retention and adherence in HIV care and treatment
Time frame: 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2012.
- Derived from this study: PubMed 22970177Turan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig R Cohen, MD, MPH principal investigator
University of California, San Francisco
Janet M Turan, PhD, MPH study director
University of California, San Francisco
Elizabeth A Bukusi, MBChB, PhD principal investigator
Kenya Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated ANC, PMTCT, HIV services in people with HIV Infections, run by University of California, San Francisco at 1 site in Kenya.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 10 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical transmission of HIV (time frame: 3 months postpartum). 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 NCT00931216, which also lists 1 linked publication.
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 10 Apr 2012.