Pre-ART Retention in Care in Tanzania

NCT01992887 | Completed

• 2 other identifiers: AAAI02513R01MH089831
• Study Type: observational
• Target: 948
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

HIV/AIDS; Retention; ART (anti-retroviral therapy) ineligible

Outcome Measures

Primary Outcomes (1)

• Proportion of those lost to follow-up (LTF) who are no longer engaged in HIV care

  24 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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.

You may not qualify if:

• \<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)
• ≥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.
• \<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:

Sponsors & Collaborators

• Columbia University: lead
• Ministry of Health and Social Welfare, Tanzania: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Ndolage District Hospital

Kamachumu, Kagera, Tanzania

Location

Mugana District Hospital

Mugana, Kagera, Tanzania

Location

Nyakahanga District Hospital

Nyakahanga, Kagera, Tanzania

Location

Rubya District Hospital

Rubya, Kagera, Tanzania

Location

Related Publications (4)

• 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.

  PMID: 20586956 BACKGROUND

• 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.

  PMID: 17941716 BACKGROUND

• 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/

  PMID: 23741771 BACKGROUND

• WHO (2009). Towards Universal Access: Scaling up priority HIV/AIDS Interventions in the Health Sector: Progress report 2009. Geneva, WHO.

  BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Batya Elul, PhD, MSc

  ICAP-NY, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Epidemiology

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 25, 2013
• Study Start: March 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: February 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

TA (4)