Human Immunodeficiency Virus (HIV) Clinical Trial
— LSTARTOfficial title:
Multi-level Determinants of Late ART Initiation in Sub-Saharan Africa (LSTART Study): A Cross-sectional Qualitative Situation Analysis at 4 HIV Care and Treatment Clinics in Ethiopia
Verified date | December 2014 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The availability of HIV care and treatment programs is increasing in sub-Saharan Africa.
However more than half the patients who need HIV medicines are still not receiving this
antiretroviral therapy (ART), and this can lead to early death from AIDS. One of the
problems in this region is that patients start ART late, after the HIV disease is very
advanced. This results in high death rates soon after ART initiation. The way clinic-level
factors, such as the way services and referrals are organized, how referrals are regarded,
counseling messages and record-keeping, contribute to late ART initiation is unclear. As the
second phase of a 3-phase NIH-sponsored project, this study will identify clinic-level
enablers and barriers to timely enrollment into HIV care and ART initiation. A
cross-sectional qualitative study will be conducted at 4 selected HIV care and treatment
clinics and the health facilities in which they are located in Ethiopia. Data will be
collected using 4 methods:
1. Data abstraction
2. Key informant interviews with clinic personnel
3. Observation of post-test counseling sessions in the VCT clinic
4. Observation of provider-patient interactions in the care and treatment clinic
Identifying modifiable health facility-level predictors of late ART initiation will
facilitate implementation of interventions, programs and policies that will increase
the number of patients who enroll in HIV care and initiate ART early. Additionally,
results will inform the design of the third phase of the NIH-project referenced above.
Status | Completed |
Enrollment | 136 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
The inclusion and exclusion criteria for the clinics and the various study participants
are given below: 1. Data abstraction Inclusion criteria: N/A - all study sites included. Exclusion criteria: N/A - all study sites included. . 2. Key informant interviews Inclusion criteria: - =18 years of age; - paid or voluntary employee in the 4 study sites for =6 months; - and give verbal informed consent. Exclusion criteria: - <18 years of age; - employed at the 4 study sites <6 months; - and/or not willing to give verbal consent. 3. Observation of post-test counseling sessions in the VCT clinic Inclusion criteria: - Providers: =18 years of age; paid or voluntary employee in the 4 study sites for =6 months; responsible for HIV post-test counseling in VCT or PICT in the adult outpatient clinic; and give verbal informed consent - Patients: =18 years of age; unaware of HIV status, and give verbal informed consent. Exclusion criteria: - Providers: <18 years of age; employed <6 months; and/or not willing to give verbal consent. - Patients: <18 years of age; and/or not willing to give verbal consent. 4. Observation of provider-patient interactions in the care and treatment clinic Inclusion criteria: - Providers: =18 years of age; paid or voluntary employee in the care and treatment clinic of 4 study sites for =6 months; and give verbal consent. - Patients: =18 years of age; not yet on ART (regardless of eligibility), receiving counseling or another service from one of the observed providers, and give verbal informed consent. Exclusion criteria: - Providers: <18 years of age; employed <6 months; and/or not willing to give verbal consent. - Patients: <18 years of age; and/or not willing to give verbal consent. |
Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Ethiopia | Fitche Hospital | Fitche | |
Ethiopia | Goba Hospital | Goba | |
Ethiopia | Nekemte Hospital | Nekemte | |
Ethiopia | Shashemene Hospital | Shashemene |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Institute of Mental Health (NIMH) |
Ethiopia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of provider-patient interactions that were observed to be rushed by visit type | Visit type includes post-test counseling, enrollment, 1st CD4, pre-ART monitoring, and ART preparatory. | 12 months | No |
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