Comorbidities and Virologic Outcome Among Patients on Anti-retroviral Therapy in Rural Lesotho

NCT02126696 | Completed

• 1 other identifier: CART-1
• Study Type: observational
• Target: 1,754
• Locations: 1 country
• Sites: 2

Brief Summary

This study is conducted in a cohort of HIV-positive patients on first-line anti-retroviral therapy (ART) in rural health facilities in Lesotho, Southern Africa. It examines virologic treatment failure as well as chronic communicable and non-communicable comorbidities among patients on ART. The study has two phases. Phase 1 consists of a cross-sectional survey to determine prevalence of treatment failure as well as the prevalence of the following comorbidities: diabetes mellitus, arterial hypertension, dyslipidemia, depression, alcohol use disorder, hepatitis B and hepatitis C. Phase 2 is a cohort study, where patients with treatment failure or a comorbidity or both are followed-up for 12 months.

Conditions

HIV; Metabolic Syndrome; Depression; Alcoholism; Hepatitis

Keywords

Anti-retroviral Therapy; Lesotho; Southern Africa; Comorbidity; Virologic failure

Outcome Measures

Primary Outcomes (2)

• Prevalence of comorbidities among patients on anti-retroviral therapy in rural Lesotho

  The prevalence of the following comorbidities/conditions will be assessed: * Diabetes Mellitus * Arterial Hypertension * Dyslipidemia * Depression * Alcohol use disorder * Hepatitis B * Hepatitis C

  at enrollment

• Prevalence of virologic failure and genotype resistance patterns among patients on anti-retroviral therapy who were not monitored virologically

  All patients on first-line ART ≥ 6 months will receive viral load testing. Those with a detectable viral load will receive enhanced adherence counselling and again a viral load measurement 3 months after the initial viral load (as recommended by the consolidated WHO-guidelines). In case of persistent virologic failure (2 times detectable viral load) a genotype resitance testing will be done and patients will be switched to second-line ART. This will allow to validate the WHO algorithm for virologic failure in a remote, resource-limited setting.

  At enrollment

Secondary Outcomes (4)

• 1-year follow-up outcomes of patients with virologic failure and subsequent switch to second-line ART

  12-18 months after enrollment

• 1-year outcomes of patients with comorbidities diagnosed at enrollment

  12-18 months after enrollment

• Predictors of sustained virologic failure 3 months after a detectable viral load at initial measurement

  enrollment + 3 months

• Association of comorbidities and virologic outcomes among patients on anti-retroviral therapy in rural Lesotho

  at enrollment

Other Outcomes (2)

• Association of patient-wealth and virologic failure among patients on ART in rural Lesotho

  at enrollment

• Virologic outcome of patients on anti-retroviral therapy at decentralized centers as compared to patients followed at the hospitals

  at enrollment

Study Arms (1)

Patients on anti-retroviral therapy

The cohort consists of patients on first-line anti-retroviral therapy since at least 6 months, followed at one of the facilities involved in the study.

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on anti-retroviral therapy ≥ 6 months followed at one of the facilities involved in the study.

You may qualify if:

• on anti-retroviral therapy ≥ 6 months
• informed consent given

You may not qualify if:

• on anti-retroviral therapy for \< 6 months or documented treatment interruption of ≥ 7 days during the last 3 months
• children \< 16 years without the caretaker who can provide informed consent for study participation
• patients on second-line anti-retroviral therapy

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Swiss Foundation for Excellence and Talent in Biomedical Research: collaborator
• SolidarMed - Swiss Organization for Health in Africa: collaborator
• University of Basel: collaborator
• Central Laboratories, University Hospitals Basel-Land (Liestal): collaborator

Study Sites (2)

Seboche Hospital

Butha-Buthe, Butha-Buthe, 400, Lesotho

Location

Paray Hospital

Thaba-Tseka, Thaba-Tseka, Lesotho

Location

Related Publications (2)

• Labhardt ND, Muller UF, Ringera I, Ehmer J, Motlatsi MM, Pfeiffer K, Hobbins MA, Muhairwe JA, Muser J, Hatz C. Metabolic syndrome in patients on first-line antiretroviral therapy containing zidovudine or tenofovir in rural Lesotho, Southern Africa. Trop Med Int Health. 2017 Jun;22(6):725-733. doi: 10.1111/tmi.12872. Epub 2017 May 4.

  PMID: 28342180 DERIVED

• Cerutti B, Broers B, Masetsibi M, Faturiyele O, Toti-Mokoteli L, Motlatsi M, Bader J, Klimkait T, Labhardt ND. Alcohol use and depression: link with adherence and viral suppression in adult patients on antiretroviral therapy in rural Lesotho, Southern Africa: a cross-sectional study. BMC Public Health. 2016 Sep 8;16(1):947. doi: 10.1186/s12889-016-3209-4.

  PMID: 27608764 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen human plasma

MeSH Terms

Conditions

Metabolic Syndrome; Depression; Alcoholism; Hepatitis

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Liver Diseases; Digestive System Diseases

Study Officials

• Niklaus D Labhardt, MD, MIH

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

• Christoph Hatz, Prof

  Swiss Tropical & Public Health Institute

  STUDY DIRECTOR

• Thomas Klimkait, Prof

  Department of Biomedicine, University of Basel

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: April 30, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

LE (2)