Pre-ART Retention in Care in Tanzania (PARC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ministry of Health and Social Welfare, Tanzania
Information provided by (Responsible Party):
Batya Elul, Columbia University
ClinicalTrials.gov Identifier:
NCT01992887
First received: November 8, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Incidence of Missed Visits [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Researchers will prospectively monitor clinical patient data to assess missed visits of patient who are enrolled in HIV care but have not initiated ART.


Secondary Outcome Measures:
  • Incidence Lost-to-Follow-Up [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Researchers will prospectively monitor clinical patient data to assess loss-to-follow-up among patients who are enrolled in HIV care but have not yet initiated ART.


Estimated Enrollment: 964
Study Start Date: March 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
In-depth Interview
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).
Prospective Cohort
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.

Detailed Description:

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:

  1. To describe themes in barriers and enablers to retention and engagement in HIV care;
  2. To conduct structured interviews to gather relevant baseline information on potential determinants of non-retention and non-engagement in HIV care;
  3. 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
  4. 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.

  1. 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).
  2. 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.
  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

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.

Criteria

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:

  • ≥18 years of age
  • ART naïve (unless for prior PMTCT)
  • made at least one clinic visit prior to study enrollment
  • unknown ART eligibility,
  • willing to give informed consent.

ii) Exclusion criteria:

  • <18 years of age
  • initiated ART other than PMTCT prior to enrollment
  • have known ART eligibility or ineligibility
  • not willing to give informed consent.

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:

  • ≥18 years of age
  • ART naïve (unless for prior PMTCT)
  • made at least one clinic visit prior to study enrollment
  • known ART ineligibility
  • willing to give informed consent.

ii) Exclusion criteria:

  • <18 years of age
  • initiated ART other than PMTCT prior to enrollment
  • have known ART eligibility
  • not willing to give informed consent

Health care workers will be purposefully selected for participation according to the following criteria:

i) Inclusion criteria:

  • ≥18 years of age
  • have worked at that HIV clinic more than any other post within the hospital for at least 6 months
  • medical officer, clinical officer or nurse
  • willing to give informed consent.

ii) Exclusion criteria:

  • <18 years of age
  • primarily posted at another clinic (just part-time or tempory assignment to HIV clinic)
  • not willing to give informed consent

PROSPECTIVE COHORT

Patients that meet the following criteria will be included in the prospective study cohort:

i) Inclusion criteria:

  • ≥18 years of age
  • ART naïve (unless for prior PMTCT)
  • enrolled in the study CTC
  • ART-ineligible or of indeterminate ART eligibility
  • willing to provide written informed consent,contact information and accept a home visit to verify outcomes if they become LTF.

ii) Exclusion criteria:

  • <18 years of age
  • initiated ART other than PMTCT prior to study enrollment
  • ART eligible
  • and/ or not willing to provide written informed consent, contact information or accept a home visit if LTF.
  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: NCT01992887

Locations
Tanzania
Ndolage District Hospital
Kamachumu, Kagera, Tanzania
Mugana District Hospital
Mugana, Kagera, Tanzania
Nyakahanga District Hospital
Nyakahanga, Kagera, Tanzania
Rubya District Hospital
Rubya, Kagera, Tanzania
Sponsors and Collaborators
Columbia University
Ministry of Health and Social Welfare, Tanzania
Investigators
Principal Investigator: Batya Elul, PhD, MSc ICAP-NY, Columbia University
  More Information

Publications:
Responsible Party: Batya Elul, Assistant Professor of Clinical Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01992887     History of Changes
Other Study ID Numbers: AAAI0251, 3R01MH089831
Study First Received: November 8, 2013
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
HIV/AIDS
Retention
ART (anti-retroviral therapy) ineligible

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 September 14, 2014