Clinical trial NCT01992887: Pre-ART Retention in Care in Tanzania
Official title: Retention and Engagement in Care of Patients Prior to ART Initiation in the Kagera Region of Tanzania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV (Human Immunodeficiency Virus)
AIDS (Acquired Immunodeficiency Syndrome)
Keywords: HIV/AIDS
Retention
ART (anti-retroviral therapy) ineligible
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Social Welfare, Tanzania
name: National Institute of Mental Health (NIMH)
First posted: 2013-11-25
Enrollment: 948
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Proportion of those lost to follow-up (LTF) who are no longer engaged in HIV care
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kamachumu
country: Tanzania
facility: Ndolage District Hospital
state: Kagera
city: Mugana
country: Tanzania
facility: Mugana District Hospital
state: Kagera
city: Nyakahanga
country: Tanzania
facility: Nyakahanga District Hospital
state: Kagera
city: Rubya
country: Tanzania
facility: Rubya District Hospital
state: Kagera
Study officials:
affiliation: ICAP-NY, Columbia University
name: Batya Elul, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fox MP, Rosen S. Patient retention in antiretroviral therapy programs up to three years on treatment in sub-Saharan Africa, 2007-2009: systematic review. Trop Med Int Health. 2010 Jun;15 Suppl 1(s1):1-15. doi: 10.1111/j.1365-3156.2010.02508.x.
citation: Rosen S, Fox MP, Gill CJ. Patient retention in antiretroviral therapy programs in sub-Saharan Africa: a systematic review. PLoS Med. 2007 Oct 16;4(10):e298. doi: 10.1371/journal.pmed.0040298.
citation: Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach: 2010 Revision. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138540/
citation: WHO (2009). Towards Universal Access: Scaling up priority HIV/AIDS Interventions in the Health Sector: Progress report 2009. Geneva, WHO.