Uganda Research Activities

4.22.09 Program Update: The success of Baylor-Uganda depends on its ability to deliver high quality, high impact and highly ethical family based pediatric and adolescent HIV/AIDS prevention, care and treatment services. Our clients' satisfaction is extremely important and may determine whether they return or even refer others to the clinic. In recognition of this aspect, the research unit, led by Dr. Alice Asiimwe, recently undertook a two phase client satisfaction survey aimed at establishing clients' opinion about the organization's services, interventions and initiatives. Phase 1 consisted of interviews with care takers and phase 2 consisted of focus group discussions. This was followed by data analysis and presentation of findings to management and staff. Below are a few highlights of the results:

85% of our care takers are female
53% have attained a minimum of secondary level education another 30% upper primary
93% felt that our health workers were very knowledgeable
94% caretakers feel they got the best treatment at our clinic
90% would recommend the clinic to others (90%)

Baylor-Uganda believes in continuous assessment and quality improvement; this process will be repeated periodically to ensure we maintain the highest standards for patient care.

Baylor -Uganda engages in both observational and interventional research. The Cohort, RELATES and HHV8 (described below) are some of the observational studies that are ongoing while the ARROW trial is currently the only intervention study.

The Cohort study
This study aims to assemble and follow a well characterized HIV patient cohort to generate observational data on demographics, clinical and general health status, and health outcomes of participating subjects.

The Cohort assembly started in July 2003 at the PIDC; enrolling children from 0 - 19 years who were HIV infected but ART naive, living within a 20 Km radius of Kampala, were unlikely to move for the 2 year follow up period and had attended at least two clinic visits in the past six months. Those who were willing to be followed up provided informed written consent.

A total of 408 children were enrolled; 100 adolescents and 308 children. Some children have since become adolescents and the adolescents, youth. Majority of these, have been started on HAART with only about 42 still ART naive.

Relates
This prospective cohort study aims to examine the relationship between the HIV-1 subtype infecting Ugandan children attending the Baylor-Uganda Paediatric Infectious Disease Clinic (now BCMCF-U COE) and the Postnatal Clinic of Mulago hospital, and their clinical and virological response to ART.

A total of 112 children aged between 6weeks and 16 years and were ready to initiate HAART were enrolled and are still being followed up.

HHV 8 Study
In Collaboration with the University of Washington, Baylor-Uganda has undertaken to study the natural history of primary human herpes virus 8 (HHV 8) infections in Ugandan children between birth and 3 years of age with respect to the frequency, timing and clinical presentation of primary infection. The study will recruit 30 HIV-1 and HHV-8 virus co-infected pregnant mothers with their new born children and all other children aged <7 years and recruitment started in March 2008. Study participants will be followed up until the new born child is 3 years. The information that will be generated will be central to the rational development of interventions to prevent and treat HHV-8 related disease.

So far, due to the extremely stringent recruitment criteria, less than 5 mothers and their children have been enrolled.

ARROW study (AntiRetroviral Research fOr Watoto).
The study is an open parallel group four-centre; two-country randomized controlled trial (RCT) in HIV infected children in Africa that is intended to go on for 5 years.

It aims to determine whether Clinically Driven Monitoring (CDM) will have a similar outcome in terms of disease progression or death as routine Laboratory and Clinical Monitoring (LCM) for toxicity (hematology/biochemistry) and efficacy (CD4).
It also aims to determine whether induction with 4 drugs (2 ART classes) followed by maintenance with 3 drugs (as either one or 2 classes) after 36 weeks will be more effective over the longer term than a continuous NNRTI-based triple drug regimen in terms of CD4 and clinical outcome.

HIV infected Children who were ART naive (except for perinatal or PMTCT ART) and eligible to start HAART, aged 6months to 17 years, with an adult carer who is HIV infected and is in care and gave informed written consent were enrolled.

A total of 1200 children have been enrolled from MRC/UVRI, Entebbe, JCRC, Kampala and the Baylor-Uganda Children's COE in Uganda and from UZ-CRC, Harare in Zimbabwe.

The Pharmacokinetics (PK) study:
Since conclusion of recruitment, the ARROW study has embarked on recruitment for a new sub-study. The PK study aims to evaluate the pharmacokinetics of the scored tablets of combivir, 3TC, ABC including switch from twice to once daily.

It will also address switch from liquids to tablets when the children reach 15kg. Once this study is complete it may be possible to improve adherence to antiretroviral drugs (ARVs) by reducing the pill burden and the frequency with which they are taken.