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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Swiss Foundation for Excellence and Talent in Biomedical Research
SolidarMed - Swiss Organization for Health in Africa
Department of Biomedicine - Haus Petersplatz, University of Basel
Central Laboratories, University Hospitals Basel-Land (Liestal)
Information provided by (Responsible Party):
Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:
NCT02126696
First received: April 28, 2014
Last updated: November 25, 2014
Last verified: November 2014
  Purpose

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.


Condition
HIV
Metabolic Syndrome
Depression
Alcoholism
Hepatitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study on Non-communicable and Selected Communicable Chronic Comorbidities Among HIV-positive Patients on Anti-retroviral Therapy in Rural Lesotho and Their Association to Virologic Outcome

Resource links provided by NLM:


Further study details as provided by Swiss Tropical & Public Health Institute:

Primary Outcome Measures:
  • Prevalence of comorbidities among patients on anti-retroviral therapy in rural Lesotho [ Time Frame: at enrollment ] [ Designated as safety issue: No ]

    The prevalence of the following comorbidities/conditions will be assessed:

    • Diabetes Mellitus
    • Arterial Hypertension
    • Dyslipidemia
    • Depression
    • Alcohol use disorder
    • Hepatitis B
    • Hepatitis C

  • Prevalence of virologic failure and genotype resistance patterns among patients on anti-retroviral therapy who were not monitored virologically [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 1-year follow-up outcomes of patients with virologic failure and subsequent switch to second-line ART [ Time Frame: 12-18 months after enrollment ] [ Designated as safety issue: No ]

    Patients with virologic failure at enrollment will be followed-up after 12-18 months to assess the following outcomes:

    1. clinical outcome: alive and on ART / lost to follow-up / dead
    2. virological outcome: viral load suppressed / viral load detectable

  • 1-year outcomes of patients with comorbidities diagnosed at enrollment [ Time Frame: 12-18 months after enrollment ] [ Designated as safety issue: No ]

    Patients diagnosed with a specific comorbidity at enrollment (see first primary outcome) will be followed-up to assess their outcome after one year:

    1. clinical outcome: alive and on ART / lost to follow-up / dead
    2. virologic outcome: viral load suppressed / viral load detectable

  • Predictors of sustained virologic failure 3 months after a detectable viral load at initial measurement [ Time Frame: enrollment + 3 months ] [ Designated as safety issue: No ]
    Potential clinical/laboratory predictors to predict sustained virologic failure among patients with a detectable viral load at initial measurement will be collected at enrollment.

  • Association of comorbidities and virologic outcomes among patients on anti-retroviral therapy in rural Lesotho [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
    Virologic outcome of anti-retroviral therapy will be compared between patient-groups with and without one or more of the comorbidities listed under the first primary outcome.


Other Outcome Measures:
  • Association of patient-wealth and virologic failure among patients on ART in rural Lesotho [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
    Patient wealth will be assessed using the wealth index developed by the Demographic Health Survey Lesotho (http://dhsprogram.com/publications/publication-FR241-DHS-Final-Reports.cfm). Virologic outcome of patients will be stratified by wealth-quintile

  • Virologic outcome of patients on anti-retroviral therapy at decentralized centers as compared to patients followed at the hospitals [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
    Patients will be stratified if they were followed at a health center (nurse-led) or at a hospital.


Biospecimen Retention:   Samples Without DNA

Frozen human plasma


Estimated Enrollment: 1000
Study Start Date: May 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

Background

Owing to successful scale-up and decentralization of anti-retroviral therapy (ART) in rural Lesotho, the number of persons infected with HIV who stay alive increased dramatically. The new situation of HIV having turned from a deadly disease into a chronic but manageable condition creates a new challenge to health care providers in rural facilities of the country. Patients on long-time ART may suffer from comorbidities endangering the success of ART and their health and/or from ART-failure due to development of resistance of the virus. The magnitude of the burden of comorbidities as well as ART- failure has not been examined extensively in Lesotho yet.

Objectives of the Study

The study has six major objectives:

  1. To assess the prevalence of virologic failure and genotype-resistance of HIV among patients on ART in rural Lesotho.
  2. To assess the prevalence of hepatitis C and hepatitis B among patients on ART in rural facilities in Lesotho
  3. To assess the prevalence of diabetes mellitus, arterial hypertension and dyslipidaemia among patients on ART in rural facilities in Lesotho
  4. To assess the prevalence of depression and alcohol use disorder among patients on ART in rural facilities in Lesotho
  5. To examine associations between chronic comorbidities and virologic outcome among patients on ART in rural Lesotho
  6. To follow-up patients with virologic failure and/or comorbidity(ies) among patients on ART in rural Lesotho

Design/Methods

The study is planned to take place in two districts of Lesotho: Botha-Bothe and Thaba-Tseka. Prevalence of the selected comorbidities is measured in a cross-sectional, facility-based survey in eight health centers and two hospitals from the two districts. Patients with a detectable viral load will receive enhanced adherence counselling and a second viral load measurement after 2-3 months. In case of confirmed virologic failure, a genotype resistance testing will be done before patients are switched to second-line. Patients with specific comorbidities or patients with virologic failure who had been switched to second-line ART will be followed-up in a cohort study 12-18 months after the survey.

Expected Results and Impact

Prevalence of the selected comorbidities will inform the Ministry of Health as well as its implementing partners on which chronic conditions might be most urgent to be addressed among patients on ART in Lesotho and the national HIV-programme may be used to leverage on for other chronic conditions. Data on virologic failure will inform on the prevalence of virologic failure among a previously not virologically monitored cohort. Moreover it will provide data on the resistance patterns among patients who fail on first-line ART and on the one-year outcome after switch to a second-line regimen.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  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: NCT02126696

Locations
Lesotho
Seboche Hospital
Butha-Buthe, Lesotho, 400
Paray Hospital
Thaba-Tseka, Lesotho
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Swiss Foundation for Excellence and Talent in Biomedical Research
SolidarMed - Swiss Organization for Health in Africa
Department of Biomedicine - Haus Petersplatz, University of Basel
Central Laboratories, University Hospitals Basel-Land (Liestal)
Investigators
Principal Investigator: Niklaus D Labhardt, MD, MIH Swiss Tropical & Public Health Institute
Study Director: Christoph Hatz, Prof Swiss Tropical & Public Health Institute
Study Chair: Thomas Klimkait, Prof Department of Biomedicine, University of Basel
  More Information

No publications provided

Responsible Party: Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT02126696     History of Changes
Other Study ID Numbers: CART-1
Study First Received: April 28, 2014
Last Updated: November 25, 2014
Health Authority: Lesotho: Ministry of Health

Keywords provided by Swiss Tropical & Public Health Institute:
Anti-retroviral Therapy
Lesotho
Southern Africa
Comorbidity
Virologic failure

Additional relevant MeSH terms:
Alcoholism
Depression
Metabolic Syndrome X
Alcohol-Related Disorders
Behavioral Symptoms
Chemically-Induced Disorders
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Mental Disorders
Metabolic Diseases
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 25, 2014