Clinical trial NCT02126696: Comorbidities and Virologic Outcome Among Patients on Anti-retroviral Therapy in Rural Lesotho
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Metabolic Syndrome
Depression
Alcoholism
Hepatitis
Keywords: Anti-retroviral Therapy
Lesotho
Southern Africa
Comorbidity
Virologic failure
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Swiss Foundation for Excellence and Talent in Biomedical Research
name: SolidarMed - Swiss Organization for Health in Africa
name: University of Basel
name: Central Laboratories, University Hospitals Basel-Land (Liestal)
First posted: 2014-04-30
Enrollment: 1754
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on anti-retroviral therapy ≥ 6 months followed at one of the facilities involved in the study.

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.

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 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

Primary outcomes:
measure: Prevalence of comorbidities among patients on anti-retroviral therapy in rural Lesotho
timeFrame: at enrollment
measure: Prevalence of virologic failure and genotype resistance patterns among patients on anti-retroviral therapy who were not monitored virologically
timeFrame: At enrollment
Secondary outcomes:
measure: 1-year follow-up outcomes of patients with virologic failure and subsequent switch to second-line ART
timeFrame: 12-18 months after enrollment
measure: 1-year outcomes of patients with comorbidities diagnosed at enrollment
timeFrame: 12-18 months after enrollment
measure: Predictors of sustained virologic failure 3 months after a detectable viral load at initial measurement
timeFrame: enrollment + 3 months
measure: Association of comorbidities and virologic outcomes among patients on anti-retroviral therapy in rural Lesotho
timeFrame: at enrollment
Other outcomes:
measure: Association of patient-wealth and virologic failure among patients on ART in rural Lesotho
timeFrame: at enrollment
measure: Virologic outcome of patients on anti-retroviral therapy at decentralized centers as compared to patients followed at the hospitals
timeFrame: at enrollment
Locations:
city: Butha-Buthe
country: Lesotho
facility: Seboche Hospital
city: Thaba-Tseka
country: Lesotho
facility: Paray Hospital
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Niklaus D Labhardt, MD, MIH
role: PRINCIPAL_INVESTIGATOR
affiliation: Swiss Tropical & Public Health Institute
name: Christoph Hatz, Prof
role: STUDY_DIRECTOR
affiliation: Department of Biomedicine, University of Basel
name: Thomas Klimkait, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.