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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126696
• Other study ID #: CART-1
• Status: Completed
• Phase: N/A
• First received: April 28, 2014
• Last updated: April 19, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lesotho: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1754
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Alcoholism
• Depression
• Hepatitis
• HIV
• Metabolic Syndrome
• Metabolic Syndrome X

Locations

Country	Name	City	State
Lesotho	Seboche Hospital	Butha-Buthe
Lesotho	Paray Hospital	Thaba-Tseka

Sponsors (5)

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

Country where clinical trial is conducted

Lesotho, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	at enrollment	No
Other	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.	at enrollment	No
Primary	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	No
Primary	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	No
Secondary	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: clinical outcome: alive and on ART / lost to follow-up / dead; virological outcome: viral load suppressed / viral load detectable	12-18 months after enrollment	No
Secondary	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: clinical outcome: alive and on ART / lost to follow-up / dead; virologic outcome: viral load suppressed / viral load detectable	12-18 months after enrollment	No
Secondary	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.	enrollment + 3 months	No
Secondary	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.	at enrollment	No