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
Sponsor study identifier
observational
1,754
1 country
2
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 28, 2014
Actual (reported)April 30, 2014
Actual (reported)May 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 2014
Actual (reported)December 2015
Actual (reported)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
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.
Patients on anti-retroviral therapy ≥ 6 months followed at one of the facilities involved in the study.
Seboche Hospital
Butha-Buthe, Butha-Buthe, 400, Lesotho
Paray Hospital
Thaba-Tseka, Thaba-Tseka, Lesotho
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.
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.
Frozen human plasma
Niklaus D Labhardt, MD, MIH
Swiss Tropical & Public Health Institute
Christoph Hatz, Prof
Swiss Tropical & Public Health Institute
Thomas Klimkait, Prof
Department of Biomedicine, University of Basel
1,754 participants (actual enrollment reported by the registry).
First Submitted
April 28, 2014
First Posted
April 30, 2014
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Computer-Based Intervention in HIV-Positive Young Adults
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
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
Contact the study team to confirm eligibility.
Primary Completion
November 2014
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
April 21, 2016
Record last verified: 2016-04
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