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

Swiss Tropical and Public Health (TPH) Institute

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT02126696

CART-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,754 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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

Trial design

1,754 participants in 1 patient group

Patients on anti-retroviral therapy

Description:

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.