The Medical Research Council (MRC) has worked in Uganda since 1989 conducting population-based

evaluations in conjunction with the MOH and other partners to inform the control of the HIV/AIDS epidemic

and its consequences. For example, in collaboration with the Uganda Virus Research Institute and London

School of Hygiene and Tropical Medicine MRC is currently conducting large-scale field trails on HIV-

prevention strategies and ARV therapy approaches. As part of this, they have over 40 clusters, defined as

groups of communities being evaluated. In late FY04 a partnership between MRC, CDC and TASO was

established to conduct an evaluation to compare facility- and home-based ART service delivery systems.

The study population comprises 1000 current TASO clients served in the Jinja District branch. During that

time the study protocol was developed and approved, and systems to begin data collection were designed.

In FY05 activities focused on training TASO health care providers in delivering ART services to clients using

both the facility-based and home-based service delivery models; the enrollment of clients for the evaluation;

initial client registration data collection; an analysis of the existing TASO services and data for the clients

enrolled. In FY06, MRC through a sub-partner agreement with TASO provided funding to procure ART and

other related OI drugs for the 1,000 clients recruited as part of the targeted evaluation.

In FY08 follow-up of clients on ART will continue and clinical, laboratory, social, economic and behavioral

data will be recorded. The purpose of the evaluation is to follow the 1000 ART clients enrolled to measure

the two service delivery models effectiveness and costs, client behavior and adherence and, family

counseling and testing uptake. Other related MRC activities outlined in the strategic information section are

to provide support and technical assistance to TASO's HMIS unit and assist TASO with the conduct of

population-based client survey on behavior with treatment and adherence to the drug regime. The activity

will strengthen TASO's capacity in the collection and interpretation of client and service delivery data to

inform clinical services and program management. MRC/UVRI will also conduct the evaluation activities to

compare the effectiveness of both strategies. The primary outcome indicator for this evaluation is the

number of clients who experience treatment failure as measured by a viral load of >500 copies/microlitre

after initial successful viral suppression. Other outcomes include treatment adherence and uptake of VCT

services by clients' family members. Evaluation findings will be shared as appropriate to inform the national

program and other provider on the most effective approaches for clients to access HIV care and treatment

in resource-limited settings.

FY07 COP activity number linked to PHE project: 4691

Title of study: Comparison of Facility and Home-Based Antiretroviral Therapy Delivery Systems in Uganda

Time and money summary: We began in year 1 (2004) and we expect the work to be completed in year 4,

which is 2008. We received $450,000 in Year 1, $450,000 in Year 2, $550,000 in Year 3. We require a

further $800,000 [$650,000 for the PHE, $150,000 for ARV drugs] in year 4 for completion of the work.

Local Co-investigator: The local co-investigators are Dr Heiner Grosskurth, Director, MRC Uganda and Dr

Shabbar Jaffar, Epidemiologist, London School of Hygiene & Tropical Medicine. Both are responsible for all

aspects of the research on the ground and for strategic direction.

Project description:

Overview: this project is evaluating home-based compared with facility-based delivery of antiretroviral

therapy (ART) in Jinja, South- East Uganda. This is collaboration between The AIDS Support Organisation

(TASO) which is responsible for service provision, MRC/UVRI which is conducting the evaluation, CDC

Uganda which is providing funding and technical support and the Ministry of Health.

The facility-based arm is a clinician led model, where clinical staff play the major role in managing patients

at the health facility. In the home-based strategy, non-clinical field officers deliver drugs and monitor and

support patients in the home. Patients also have access to clinicians but routine clinical appointments are

less frequent than for patients following the facility-based strategy. All patients are managed by a health

service provider (TASO) in close to normal health service conditions.

Evaluation Question: The study is evaluating whether home-based HIV care is approximately equivalent to

a standard facility-based approach. This will inform the public health authorities on the relative values of

these two strategies and could be invaluable information for scaling-up and sustaining ART.

Study design: We are comparing home-based care with a facility-based approach using a cluster

randomised trial. The evaluation is integrated into routine service delivery. The duration of recruitment of

patients and the evaluation is planned to be 4 years. Our primary evaluation measure is plasma viral load

(i.e. we will compare the two strategies in terms of virological failure). We are also measuring cost-

effectiveness, reported adherence, rate of uptake of voluntary counseling and testing among family

members.

Importance/planned use of findings: Experience with ART in Africa especially in the public setting has been

limited. Little is known about which health delivery strategy would lead to better treatment effectiveness in a

setting where there is shortage of qualified medical personnel and health systems are weak and difficult to

access for patients. The evaluation will provide much needed information on the effectiveness of the two

ART delivery strategies and on adherence, sexual behaviour, uptake of voluntary counselling and testing

morbidity and mortality over a 3 year duration. Information generated from this evaluation will be of

immediate use to the people of Uganda and other resource limited settings.

Status of study/progress to date: is protocol developed, in scientific/human subjects/phe review, in

implementation? If behind schedule, please explain delays & plans to remedy/revised timeline.

The protocol is developed and has received ethical clearance. Enrolment of subjects into the study was

completed. Follow-up of subjects is continuing on schedule. A total of 1477 trial patients were invited to join

the evaluation, only 24 (1.6 %) refused to join the trial. Recruitment of subjects into the evaluation began on

5th February 2005 and ended on 7th December 2006. By 17 July 2007 3 (1.2%) subjects were lost to

follow-up and 78(5.4%) had withdrawn from the evaluation largely because they have moved out of the

catchment area (all 78 are still receiving antiretroviral therapy (ART)). In addition, 153 (10.5%) subjects

have died, and there have been 151 admissions to hospital of 125 subjects. The rates of deaths and

hospital admissions are broadly similar to other studies in resource limited settings.

Lessons Learned: We have not published any articles. We are in the preliminary stages of this study and

are not in a position to formally analyze our data. However, our data collection systems and follow-up of

subjects is complete and up-to-date. The study has high co-operation both from patients and from the public

health authorities.

Information Dissemination Plan: Information on the progress of this evaluation is regularly fed back to the

Ministry of Health, the AIDS Control Programme (ACP) and Uganda AIDS Commission (UAC) , TASO and

the patients. This information is being used to strengthen the ART services in the country. These meetings

will continue to be an avenue for giving feedback to all stakeholders. After the evaluation, we will

disseminate the findings to both trial subjects, the health services and ACP and UAC and other policy

makers. We will do this through meetings and presentations We will also publish the findings in international

journals in collaboration with our partners.

Planned FY08 activities

We will continue to monitor and follow-up study subjects enrolled in the evaluation. We will continue to

collect data on study subjects including on virological response, CD4 counts, reported adherence to

medication, costs of accessing care. Some of these data will be collected through laboratory testing. Some

through interview of study subjects. We will also continue to collect health services data including their costs

of delivering care.

We will continue to hold meetings between study investigators and the different stakeholders to inform them

of trial progress.

Salaries/fringe benefits: $ 360,000

Equipment: 0

Supplies: $40,000

Travel: $60,000

Participant Incentives: 0

Laboratory testing: $120,000

Other: $70,000

Activity Narrative: Total: $650,000

We have asked for $360,000 for staff salaries for over 20 full-time staff. We need the staff for various

evaluation activities. We have not requested major equipment as this has been purchased from past

budgets. We have requested $30,000 for minor equipment, stationary (e.g. printing questionnaires), office

consumables (e.g. rent) and laboratory consumables. We asked for $60,000 travel to cover the costs of field

work operations (e.g. fuel supplies, insurance for vehicles, repairs) and for overseas travel. We have asked

$120,000 for plasma viral load testing and other laboratory testing. These are essential endpoints of the

trial. We have asked for $70,000 for other costs, which includes telephone and email services, electricity,

security, and overheads.