Multi-level Determinants of Starting ART Late: Aim 2 (LSTART)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Batya Elul, Columbia University
ClinicalTrials.gov Identifier:
NCT01997346
First received: November 8, 2013
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.

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

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Proportion of adults initiating ART at advanced disease stage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Abstraction data from electronic patient-level database will be assessed at enrollment (looking at all data 18 months prior to study start date), 6 months, and 12 months to assess the proportion of adults who initiated ART at advance stages of HIV infection.


Secondary Outcome Measures:
  • Number of patients who miss visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To assess the number of patients who miss visits, we will be examining the peer educator defaulter tracing registers which are used at all clinics.

  • Percent of HIV-positive patients who enroll in ART [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Abstraction data from electronic patient-level database will be assessed at enrollment (looking at all data 18 months prior to study start date), 6 months, and 12 months to determine the percentage of HIV-positive patients that initiate ART at each site.

  • Median CD4 count at enrollment [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Abstraction data from electronic patient-level database will be assessed at enrollment (looking at all data 18 months prior to study start date), 6 months, and 12 months to assess the median CD4 count of HIV-positive patients at the time they enroll in ART.

  • Average number of days between positive HIV-test and ART enrollment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Abstraction data from electronic patient-level database will be assessed at enrollment (looking at all data 18 months prior to study start date), 6 months, and 12 months to tabulate the average number of days between when a patient test positive for HIV and when they enroll in ART.


Enrollment: 136
Study Start Date: November 2011
Estimated Study Completion Date: February 2015
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997346

Locations
Ethiopia
Fitche Hospital
Fitche, Ethiopia
Goba Hospital
Goba, Ethiopia
Nekemte Hospital
Nekemte, Ethiopia
Shashemene Hospital
Shashemene, Ethiopia
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Batya Elul, PhD, MSc ICAP-NY, Columbia University
  More Information

No publications provided

Responsible Party: Batya Elul, Assistant Professor of Clinical Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01997346     History of Changes
Other Study ID Numbers: AAAI1192, 1R01MH089831
Study First Received: November 8, 2013
Last Updated: November 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
ART initiation
Ethiopia
Clinic observation
VCT observation

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 10, 2014