Kumasi Cohort Study

Summary

The main objective is to access efficacy of first and second line antiretroviral therapy (ART) and its determinants in patients treated at the Komfo Anokye Teaching Hospital in Kumasi (KATH), Ghana, and to compare the clinical, virological and immunological efficacy of second line ART in patients who were switched after virological failure compared to patients who were switched after clinical or immunological failure.

Other specific study objectives are:

1. To establish an HIV Cohort Study at the study site.
2. To assess the rate of virological failure among patients on first line therapy
3. To compare the clinical, immunological and virological efficacy of second line antiretroviral therapy amongst patients randomised to virological monitoring whilst on first line compared with those monitored routinely using clinical and immunological monitoring.
4. To assess the incidence and outcome of tuberculosis (TB) and other opportunistic infections in patients treated at the Komfo Anokye Teaching Hospital HIV services
5. To obtain parameters for quality of care, e. g. performance of TB screening procedures
6. To develop strategies to minimise treatment failures, on the basis of the results of the study
7. To generate a large prospective second-line ART cohort, to serve as basis for further research projects
8. To implement point-of-care viral load analysis at the Komfo Anokye Teaching Hospital
9. Capacity building: epidemiology, medical documentation and data base management. Enrollment of one PhD and one Master student

Conditions

• HIV

Interventions

OTHER

Virological monitoring

Sponsors & Collaborators

• Kwame Nkrumah University of Science and Technology

  collaborator OTHER

• Kumasi Centre for Collaborative Research (KCCR)

  collaborator OTHER

• Komfo Anokye Teaching Hospital

  collaborator OTHER

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Bernhard Nocht Institute for Tropical Medicine

  lead OTHER_GOV

Principal Investigators

• Fred S Sarfo, FWACP, PHD · Kwame Nkrumah University of Science and Technology

• Kirsten A Eberhardt, Dr., MD · Bernhard Nocht Institute for Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2021-06-28

Completion

2021-07-28

Countries

• Ghana

Study Locations