Multi-level Determinants of Starting ART Late: Aim 2

Human Immunodeficiency Virus (HIV) Clinical Trial

— LSTART  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997346
• Other study ID #: AAAI1192
• Secondary ID: 1R01MH089831
• Status: Completed
• Phase: N/A
• First received: November 8, 2013
• Last updated: December 15, 2014
• Start date: November 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

Background: Although HIV care and treatment programs are scaling up in sub-Saharan Africa, more than 50% of patients who need ART are not receiving it and significant mortality from AIDS persists. One major challenge in this region is high rates of late ART initiation (i.e., in the advanced stages of HIV disease) which results in high rates of mortality soon after ART initiation. The clinic-level factors that contribute to late ART initiation are unclear.

Objective: As the second of a 3-phase NIH-sponsored project, this study aims to identify clinic-level enablers and barriers to timely ART initiation.

Methods: A cross-sectional qualitative study will be conducted at 4 purposively selected HIV care and treatment clinics 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 at the voluntary counseling and testing (VCT) clinic

4. Observation of provider-patient interactions in the care and treatment clinic Descriptive statistics will be produced from the data abstraction. Content analysis of key informant interviews will be conducted. Descriptive summaries will be produced from observations. All analyses will focus on identifying within- and across-clinic themes, and include triangulation across data collection methods to identify clinic-level enablers and barriers to timely ART initiation.

Expected use of results: Identifying modifiable clinic-level enablers and barriers to timely ART initiation will facilitate implementation of interventions, programs and policies to reduce late ART initiation. Additionally, results will inform the third phase of the NIH-project referenced above.

Recruitment information / eligibility

• 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.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome (AIDS)
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
Ethiopia	Fitche Hospital	Fitche
Ethiopia	Goba Hospital	Goba
Ethiopia	Nekemte Hospital	Nekemte
Ethiopia	Shashemene Hospital	Shashemene

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Ethiopia, 

Outcome

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