Multi-level Determinants of Starting ART Late: Aim 2

Completed

• Conditions: Human Immunodeficiency Virus (HIV); Acquired Immune Deficiency Syndrome (AIDS)

• Registration Number: NCT01997346
• Lead Sponsor: Columbia University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-28
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of provider-patient interactions that were observed to be rushed by visit type	12 months	Visit type includes post-test counseling, enrollment, 1st CD4, pre-ART monitoring, and ART preparatory.

Trial Locations

Locations (4)

Nekemte Hospital; 🇪🇹 Nekemte, Ethiopia

Shashemene Hospital; 🇪🇹 Shashemene, Ethiopia

Goba Hospital; 🇪🇹 Goba, Ethiopia

Fitche Hospital; 🇪🇹 Fitche, Ethiopia