An observational study in HIV, Metabolic Syndrome and Depression, sponsored by Swiss Tropical & Public Health Institute. Completed at 2 sites in Lesotho. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2016-04-21.
Sponsored by Swiss Tropical & Public Health Institute · Observational
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.
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:
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.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's enrollment of 1,754 is above the median of 197 across 496 observational studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Swiss Tropical & Public Health Institute is the lead sponsor of 58 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients on anti-retroviral therapy ≥ 6 months followed at one of the facilities involved in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: 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.
Time frame: At enrollment
1-year follow-up outcomes of patients with virologic failure and subsequent switch to second-line ART
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
Time frame: 12-18 months after enrollment
1-year outcomes of patients with comorbidities diagnosed at enrollment
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
Time frame: 12-18 months after enrollment
Predictors of sustained virologic failure 3 months after a detectable viral load at initial measurement
Potential clinical/laboratory predictors to predict sustained virologic failure among patients with a detectable viral load at initial measurement will be collected at enrollment.
Time frame: enrollment + 3 months
Association of comorbidities and virologic outcomes among patients on anti-retroviral therapy in rural Lesotho
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.
Time frame: at enrollment
Association of patient-wealth and virologic failure among patients on ART in rural Lesotho
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
Time frame: at enrollment
Virologic outcome of patients on anti-retroviral therapy at decentralized centers as compared to patients followed at the hospitals
Patients will be stratified if they were followed at a health center (nurse-led) or at a hospital.
Time frame: at enrollment
The record gives a start of May 2014, a primary completion of Nov 2014 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Swiss Tropical & Public Health Institute