Multi-level Determinants of Starting ART Late: Aim 2

NCT01997346 | Completed

• 2 other identifiers: AAAI11921R01MH089831
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 4

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. 1.Data abstraction
2. 2.Key informant interviews with clinic personnel
3. 3.Observation of post-test counseling sessions in the VCT clinic
4. 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.

Conditions

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

Keywords

ART initiation; Ethiopia; Clinic observation; VCT observation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Key Informant Interviews

We will conduct interviews with 4 clinic personnel (16 across the 4 sites) to learn about practices and provider perspectives in the HIV clinic or ancillary clinics such as VCT. The 4 clinic personnel in each site will include: the physician-in-charge, a nurse, one peer educator, and a nurse or community counselor from the VCT clinic. A semi-structured interview guide will be used to query respondents about: procedures for enrolling new clients, conducting active testing, identifying and initiating patients on ART, CD4 monitoring, tracking clients who have missed appointments, support programs, and peer education. We will also aim to understand how each respondent views her/his role, how s/he counsels patients on pre-ART care, and the challenges faced from each one's perspective.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will conduct key informant interviews with 4 clinic personnel (16 across the 4 sites) to learn about actual practices and provider perspectives in the HIV clinic or ancillary clinics such as VCT. The 4 clinic personnel in each site will include: the physician-in-charge of the HIV clinic, a nurse working in the HIV clinic, one peer educator from the HIV clinic, and a nurse or community counselor from the VCT clinic.

You may not qualify if:

• Data abstraction
• Key informant interviews
• ≥18 years of age;
• paid or voluntary employee in the 4 study sites for ≥6 months;
• and give verbal informed consent.
• \<18 years of age;
• employed at the 4 study sites \<6 months;
• and/or not willing to give verbal consent.
• Observation of post-test counseling sessions in the VCT clinic
• 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.
• 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.
• Observation of provider-patient interactions in the care and treatment clinic
• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Fitche Hospital

Fichē, Ethiopia

Location

Goba Hospital

Goba, Ethiopia

Location

Nekemte Hospital

Nekemte, Ethiopia

Location

Shashemene Hospital

Shashemenē, Ethiopia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Batya Elul, PhD, MSc

  ICAP-NY, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Epidemiology

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 28, 2013
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

ET (4)