This activity contributes to the Uganda National HIV care and support goal of improving the quality of life of

people living with HIV/AIDS (PHAs). (Uganda's National Strategic Framework on HIV/AIDS).

AIDS Information Centre-Uganda (AIC) is a Non-Governmental Organization established in 1990 to provide

Voluntary Counseling and Testing (VCT) services on the premise that knowledge of ones own sero-status is

an important determinant in controlling the spread of HIV. AIC also uses HCT as an entry point for the

provision of and referral to HIV/AIDS service-provider initiated services including prevention of HIV

transmission, treatment of opportunistic infections, like Tuberculosis, PMTCT and ART services as well as

other care and support services.

TB and HIV are two diseases that make each other worse implying the need to scale up on HIV-TB

integration. Mycobacterium tuberculosis infects a third of the world's population. Uganda is one of the

world's 22 TB high-burden countries, and it is an estimated trend in incidence rate of 2.2% per year and an

incidence of 175 smear positive TB cases per 100,000 people per year [WHO, 2006]. TB is one of the most

common causes of morbidity and the leading cause of mortality in people living with HIV/AIDS. HIV is the

biggest risk factor for the development of active TB and at present an estimated 50% of TB patients are also

co-infected with HIV [MOH-NTLP, 2004]. The provision of latent TB screening and treatment is however not

widespread. For those who receive the nine month treatment there is still an increasing number of cases

who fail to adhere to the complete treatment requiring follow up. Among the achievements, AIC has

registered during FY07 is offering education on TB to 118,302 clients who had come for VCT, prophylactic

INH (IPT) to a total of 2,420 clients in its 4 branches of Kampala, Jinja, Mbarara and Mbale. Of these 16

have developed active TB during IPT. The number receiving treatment for active TB was 433, with 67

(15.4%) defaulting and 1 on re-treatment. There has been relative good follow up with education during out-

reaches. AIC has had successful external quality control carried out by CDC/UVRI, re-trained 12 laboratory

technicians on TB diagnosis and 10 medical counselors on screening, treatment and referral mechanisms

for those suspected or have TB disease.. Over all AIC has contributed to policy development on TB/HIV

collaborative approach at National fora.

During FY 08, AIC will provide clinical examination, clinical monitoring, laboratory services, treatment and

prevention of TB in all the 8 branches. AIC will offer preventive therapy (IPT) to the eligible clients as well

as screening and treatment for active TB among the HIV infected clients. During FY 08, AIC will provide

IPT to 15,000 clients and active TB treatment to 500 individuals. To improve drug adherence, AIC will

implement the DOTS program in all its branches covering 1,000 clients. These clients will also receive

treatment for OIs and will be initiated on ART.

In collaboration with selected 24 health facilities, AIC will provide TB diagnostic services for HIV positive

clients. Those found to be infected with HIV will be provided with CD4 cell counts and later on referred for

ART. All TB suspects and patients in the supported health facilities will be offered HIV counseling and

testing. Work practice TB infection control measures will be implemented, involving training of health

workers and education of patients on TB infection control.

Training will be offered to staff and volunteers to identify clients suspicious of having TB disease, during out

reach visits and refer them to AIC branches and supported sites for screening. A total of 50 service

providers will be trained in HIV/TB and ART management.

FY07 COP Activity ID#:10036

Title of study: Evaluating the Utility of Re-testing HIV-negative VCT clients

Time and money summary: This is year 2 of the activity, and is expected to be completed in the second

year. Funds received in the first year were US$ 35,000. These funds will be expended in the second year.

Local Co-investigator:

Principal Investigator: Wolfgang Hladik

Co- Investigators:

CDC staff : Robert Downing, Fulgentius Baryarama, Jordan Tappero, Rosemary Odeke

AIDS Information Center (AIC) - Uganda: Raymond Byaruhanga, Geoffrey Mulindwa.

Project Description:

Substantial PEPFAR funds are being used for the provision of voluntary counseling and testing (VCT). In

Uganda and other sub-Saharan African countries, VCT guidelines often recommend re-testing of HIV-

negative clients after 3-6 months to rule out the possibility of "window period infections", i.e., shortly after

infection onset but before the appearance of HIV antibodies. Scientific literature suggests that this period is

just 2-4 weeks long. At the AIDS Information Center (AIC), 33% of all testing during 2002-2005 was

performed for this purpose, implying that substantial resources are spent to identify a potentially very small

group of HIV-infected clients.

Evaluation Question:

We propose to evaluate the utility of repeat-testing for VCT clients who initially tested HIV-negative. The

objective is to estimate the likelihood of HIV-negative clients actually being HIV-infected and the potential

costs saved by discontinuing this policy.

Methodology:

Routine client questionnaire data will be analyzed to determine the proportion of repeat testers who likely

repeat-test due to repeated risk behavior and that who return because of the counseling message

recommending repeat testing.

Left-over blood specimens from VCT clients frequenting AIC centers already are routinely collected and

stored for further testing with informed consent. Approximately 100,000 HIV-negative blood specimens will

be pooled in small batches and tested for HIV DNA/RNA. The number and proportion of first-time HIV-

seronegative testers actually infected will be determined. Testing and total program costs to identify such

persons will be estimated. Identified seronegative but virus-positive VCT clients will be contacted for

retesting and re-counseling. A sufficiently large sample size provided, risk factors (using the routine

questionnaire data) for truly incident HIV infections will be evaluated.

Population of Interest:

VCT clients at AIC sites. The findings are likely applicable to all (HIV-negative) VCT clients and VCT

facilities in Uganda and will be of interest for other PEPFAR countries.

(a)HIV-pos life expectancy (in weeks, assuming a median of 9 yrs) 459

(b)Window period (weeks) 2

(c)Estimated probability to test during window period (b/a) 0.4%

(d)Estimated HIV-prevalence in first-time VCT clients 8%

(e)Target sample size (# HIV seronegative clients to be tested) 100,000

(f)Total sample (HIV-neg and HIV-pos clients) (e/[1-d]) 108,696

(g)Proportional No. of expected # HIV seropositive clients (f*d) 8,696

(h)Of these, estimated # infected in window period (g*c) 38

(i)Probability HIV-seroneg client is HIV antigen-pos (h/e) 0.04%

(j)95% confidence limits 0.028%-0.052%

(k)No. spx per batch tested 20

(l)Estimated No. batches HIV-DNA/RNA-pos (h) 38

(m)Cost per Taqman run $6.00

Estimated total number of Taqman runs (k*l+e/k) 5,758

Total estimated testing costs: $35,000

Costs are mainly related to PCR testing. Specimen and data collection as well as analysis are covered by

AIC's and CDC's operational budget

Status of study/progress to date:

The protocol was approved by Atlanta GAP and Center ADS on August 13th 2007. The onset of the study

was delayed awaiting approval. Since the approval has just been obtained the study is behind schedule and

the completion date has been revised to April 2008.

Information Dissemination Plan:

Relevant findings may be presented at meetings or published. The significance and implications of these

findings will be discussed with VCT program staff.

Planned FY08 activities: Laboratory testing and data analysis

Budget Justification for FY08 monies

Salaries/fringe benefits: $0

Equipment: $0

Supplies: $0

Travel: $0

Participant Incentives: $0

Laboratory testing: $0

Other: $0

Activity Narrative: Total: $0