Pre-ART Retention in Care in Tanzania (PARC)
|ClinicalTrials.gov Identifier: NCT01992887|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : May 13, 2016
|Condition or disease|
|HIV (Human Immunodeficiency Virus) AIDS (Acquired Immunodeficiency Syndrome)|
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:
- To describe themes in barriers and enablers to retention and engagement in HIV care;
- To conduct structured interviews to gather relevant baseline information on potential determinants of non-retention and non-engagement in HIV care;
- To estimate the incidence of short-term outcomes (missed visits and lost to follow-up (LTF)), including the rate and proportion of those LTF who are no longer engaged in HIV care; and
- To identify determinants of missed visits, LTF, and non-engagement in care among ART-ineligible patients.
Methods: This study will be conducted using qualitative and quantitative methods at four HIV care and treatment clinics (CTCs) in Kagera Region, Tanzania.
- Qualitative: in-depth interviews at two CTCs with up to 20 adult patients (ART naïve, and ineligible or indeterminate for ART) and about 4 health care workers; and focus group discussions (about 4 groups of about 6-10 persons/group) with adult patients (ART naïve, and ineligible or indeterminate for ART).
- Quantitative: 1) structured baseline interviews at four CTCs (n= approximately 900 adult patients who are ART naïve, and ineligible or indeterminate for ART); 2) prospective monitoring of these 900 patients using routine CTC patient data to assess missed visits and LTF; and 4) brief structured surveys of patients who become LTF and are reached through defaulter tracing efforts.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||948 participants|
|Observational Model:||Ecologic or Community|
|Target Follow-Up Duration:||24 Months|
|Official Title:||Retention and Engagement in Care of Patients Prior to ART Initiation in the Kagera Region of Tanzania|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||February 2016|
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.
Focus Group Participants
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992887
|Ndolage District Hospital|
|Kamachumu, Kagera, Tanzania|
|Mugana District Hospital|
|Mugana, Kagera, Tanzania|
|Nyakahanga District Hospital|
|Nyakahanga, Kagera, Tanzania|
|Rubya District Hospital|
|Rubya, Kagera, Tanzania|
|Principal Investigator:||Batya Elul, PhD, MSc||ICAP-NY, Columbia University|