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

Completed

• Conditions: Metabolic Syndrome; Depression; HIV; Alcoholism; Hepatitis

• Registration Number: NCT02126696
• Lead Sponsor: Swiss Tropical & Public Health Institute

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.

Study Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Study Start: 2014-05
• Primary Completion: 2014-11
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1754

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of comorbidities among patients on anti-retroviral therapy in rural Lesotho	at enrollment	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	At enrollment	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

Name	Time	Method
1-year outcomes of patients with comorbidities diagnosed at enrollment	12-18 months after 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
Association of comorbidities and virologic outcomes among patients on anti-retroviral therapy in rural Lesotho	at enrollment	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.
1-year follow-up outcomes of patients with virologic failure and subsequent switch to second-line ART	12-18 months after enrollment	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
Predictors of sustained virologic failure 3 months after a detectable viral load at initial measurement	enrollment + 3 months	Potential clinical/laboratory predictors to predict sustained virologic failure among patients with a detectable viral load at initial measurement will be collected at enrollment.

Trial Locations

Locations (2)

Seboche Hospital; 🇱🇸 Butha-Buthe, Lesotho

Paray Hospital; 🇱🇸 Thaba-Tseka, Lesotho