An observational study in HIV (Human Immunodeficiency Virus) and AIDS (Acquired Immunodeficiency Syndrome), sponsored by Columbia University. Completed at 4 sites in Tanzania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-13.
Sponsored by Columbia University · Observational
Retention of patients in HIV care following diagnosis and enrollment is critical to the long-term success of HIV care and treatment scale-up. The goal of this study is to better understand the factors that influence retention and engagement in HIV care among adult patients who are enrolled in HIV care and are not yet eligible for antiretroviral therapy (ART). The study will be conducted at four HIV care and treatment clinics (CTCs) in Kagera Region, Tanzania. This is a mixed-methods study with both qualitative (interviews) and quantitative (surveys) data collection. Our findings will be important towards designing programs that help patients remain in HIV care.
Retention of patients in HIV care following diagnosis and enrollment is a chronic challenge in both resource rich and resource poor settings (Rosen, Fox et al. 2007; WHO 2009; Fox and Rosen 2010), and is critical to the long-term success of HIV care and treatment scale-up. Most research on retention in care has focused on persons who are eligible for or have initiated antiretroviral therapy (ART), generally examined only demographic and clinical determinants. However, a large proportion of patients enrolled in HIV care (e.g., 45%, according to our data from 722 sub-Saharan African clinics) have not been determined to be ART-eligible and have not yet initiated ART; among these individuals, even less is known about the magnitude and determinants of non-retention in care. Retention in HIV care prior to ART initiation is a pre-requisite to: 1) optimal prophylaxis, diagnosis, and treatment of opportunistic illnesses (OIs); 2) effective secondary prevention of HIV transmission, such as by patient counseling and education, earlier diagnosis of infected family members and sexual partners, and prevention of mother to child transmission (PMTCT); and 3) more timely ART initiation. Retention in care among patients at earlier disease stages is also increasingly important given the WHO-recommended expansion of ART eligibility guidelines in resource-limited settings (WHO 2009).
Objective: The goal of this study is to better understand barriers and enablers to retention and engagement in HIV care among adult patients who are enrolled in HIV care and are not yet eligible for ART. The specific objectives are:
Methods: This study will be conducted using qualitative and quantitative methods at four HIV care and treatment clinics (CTCs) in Kagera Region, Tanzania.
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This study's enrollment of 948 is above the median of 239 across 367 observational studies indexed under Acquired Immunodeficiency Syndrome.
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Participants will be recruited at four HIV CTCs in the Kagera region of northwestern Tanzania. The 8,000 patients enrolled in HIV care at these clinics represent 30% of HIV patients ever enrolled in ICAP-supported clinics across Kagera Region. Patients will be eligible for selection for either in-depth interviews or focus group discussions if they have made at least one prior visit to the clinic.
QUALITATIVE COHORT
In-depth key informant interviews and focus groups will be conducted with patients that meet the following criteria:
ART-eligibility indeterminate patients (n= approximately 10 in-depth and up to 20 focus group participants, where half are from a rural site, Mugana District Hospital and half are from an urban site, Nyakahanga District Hospital)
i) Inclusion criteria:
ii) Exclusion criteria:
ART-ineligible patients (n= approximately 10 in-depth and up to 20 focus group participants, where half are from a rural site, Mugana District Hospital and half are from an urban site, Nyakahanga District Hospital)
i) Inclusion criteria:
ii) Exclusion criteria:
Health care workers will be purposefully selected for participation according to the following criteria:
i) Inclusion criteria:
ii) Exclusion criteria:
PROSPECTIVE COHORT
Patients that meet the following criteria will be included in the prospective study cohort:
i) Inclusion criteria:
ii) Exclusion criteria:
Up to 20 in-depth interviews will be conducted among adult ART naïve patients, balanced by gender, site and reason for ART naiveté (determined ineligible or eligibility not yet determined) as much as possible. Up to 4 in-depth interviews will be conducted with health care providers.
Up to 40 patients ineligible or not yet eligible for ART will be invited to join a focus group discussion. Patients will be eligible for selection for either in-depth interviews or focus group discussions if they have made at least one prior visit to the clinic. Selected patients will be balanced as much as possible by gender and by pre-ART status (e.g. roughly half pre-ART eligibility determined, and roughly half pre-ART eligibility indeterminate).
Based on historical patient data from the four study CTCs, we expect that approximately 1,000 patients will enroll in HIV care at these clinics during the study period and be determined not eligible for ART or of unknown eligibility. Assuming a 10% refusal rate, approximately 900 patients would then enroll in this study and complete baseline interviews. These 900 patients will be prospectively monitored using routinely collected patient care data for up to 24 months. Outreach workers will attempt to trace all of the enrolled patients who are observed to be LTF during the study period, and complete a defaulter tracing survey.
Proportion of those lost to follow-up (LTF) who are no longer engaged in HIV care
Time frame: 24 months
The record gives a start of Mar 2012, a primary completion of Aug 2014 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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