Human Immunodeficiency Virus (HIV)LSTARTNCT01997346
Multi-level Determinants of Starting ART Late: Aim 2
An observational study of Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS), run by Columbia University at 4 sites in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Acquired Immune Deficiency Syndrome (AIDS)
- How many people
- 136 participants
- Where
- 4 sitesEthiopia
- Study dates
- Nov 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥18 years of age;
- paid or voluntary employee in the 4 study sites for ≥6 months;
- and give verbal informed consent.
- 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; 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.
Who cannot join
- <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; employed <6 months; and/or not willing to give verbal consent.
- Patients: <18 years of age; and/or not willing to give verbal consent.
Show all 9Show fewer
- Observation of provider-patient interactions in the care and treatment clinic
- 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.
Trial locations and contacts
4 sites in 1 country.
Ethiopia4 sites
Fitche Hospital
Fichē
Goba Hospital
Goba
Nekemte Hospital
Nekemte
Shashemene Hospital
Shashemenē
About this study
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
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:
- Data abstraction
- Key informant interviews with clinic personnel
- Observation of post-test counseling sessions in the VCT clinic
- 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.
Read the 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:
- Data abstraction
- Key informant interviews with clinic personnel
- Observation of post-test counseling sessions at the voluntary counseling and testing (VCT) clinic
- 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.
- Keywords
- ART initiation, Ethiopia, Clinic observation, VCT observation
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Batya Elul, Columbia University
- Investigators
- Batya Elul, PhD, MSc, Principal investigator, ICAP-NY, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997346
- Sponsor's protocol ID
- AAAI1192
- Other IDs
- 1R01MH089831
- Acronym
- LSTART
- Status last verified
- Dec 2014
- First submitted
- 8 Nov 2013
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01997346
- Acronym / sponsor ID
- LSTART / AAAI1192
- Keywords
- ART initiation, Ethiopia, Clinic observation, VCT observation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Data abstraction
- Key informant interviews with clinic personnel
- Observation of post-test counseling sessions in the VCT clinic
- 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:
- Data abstraction
- Key informant interviews with clinic personnel
- Observation of post-test counseling sessions at the voluntary counseling and testing (VCT) clinic
- 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 design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- Observation of post-test counseling sessions in the VCT clinic
- Observation of provider-patient interactions in the care and treatment clinic
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of provider-patient interactions that were observed to be rushed by visit type
Time frame: 12 months
Visit type includes post-test counseling, enrollment, 1st CD4, pre-ART monitoring, and ART preparatory.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Batya Elul, PhD, MSc principal investigator
ICAP-NY, Columbia University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS), run by Columbia University at 4 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of provider-patient interactions that were observed to be rushed by visit type (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.