07-P0513: AED- Strengthening Prevention in Clinical and Community Settings.

This activity links with C0911, and provides complementary funding to this activity, for a total program budget of $490,000. It also links with P0505.

Background This activity involves strengthening prevention services in clinical and community services. With FY06 funding, we are supporting an assessment of the opportunities to strengthen prevention messages and services in relevant clinical and community services for PLWHA and to adapt and pilot test some tools that will help fill some of the anticipated gaps in services. Simultaneously and through a separate contract, we have supported the development of an alcohol-focused intervention that health care providers can deliver, to identify risky drinking and provide brief, motivational interviewing to promote reduction in such drinking.

For FY07, we propose to combine the two projects into a single program focused on strengthening prevention in clinical and community settings. The project will work with a limited set of health care services in FY07. Tebelopele will definitely be a partner in the project, while the others will be identified over the course of the prevention services assessment and in light of the experience of the health-care focused alcohol-HIV project to date. The project will focus on sexual transmission prevention and, where possible and appropriate, incorporate messages and methods that incorporate screening for risky alcohol use, intersections with HIV/AIDS, and brief interventions for the reduction of risky drinking.

Focus on HIV testing sites and protocols

$100,000 from the counseling and testing program area are also included in the funding for this project (CO911). This dedicated funding reflects a commitment that the FY07 activities will focus at least 33% of its effort on strengthening HIV prevention messages for clients who test positive and those who test negative in the VCT settings, including alcohol screening and interventions. The Tebelopele VCT centers, BOCAIP and other CBOs/NGOs/FBOs will be the venues for interventions. Tebelopele and other VCT centers have been conducting anonymous HIV testing, and the few clients who have returned for supportive counseling were not easily recognized and provided followup services. Tebelopele is in the process of changing its policy and begin confidential counseling, recording client names and national identification numbers (omangs) in order to provide better referral services and provide follow up palliative care to HIV infected clients and additional services for HIV negative clients as well. Protocols for use by counselors in conducting follow up prevention counseling will be developed or adapted from existing materials, such as HHS/CDC's new generic intervention for HIV prevention in care and treatment settings. It should be noted that VCT settings provide a great opportunity for HIV prevention counseling for clients including discordant couples. There is need to pilot and adapt these materials in the VCT settings in Botswana, and also to develop a concise HIV prevention package for HIV negative clients for the first and follow-up visits, for group and individual counseling.

In sum, a portion of this project will support AED to work collaboratively with VCT staff, HHS/CDC/BOTUSA and HHS/CDC headquarters in Atlanta to develop, pilot and adapt targeted prevention messages or protocols, towards strengthening the prevention services offered in VCT settings, for both HIV negative and HIV positive clients. This activity also includes providing the necessary training to VCT staff during pilot, adaptation and roll out of the intervention. It also includes the incorporation of a brief intervention for risky drinking and the intersection between alcohol and HIV, into the VCT setting counseling protocols.

Other services targeted for prevention strengthening The remainder of the effort in this program will go to other service types besides HIV testing, to strengthen prevention services, for PLWHA and for people of unknown and negative status. The FY06 "PwP" assessment will identify additional services and groups, like Tebelopele, that are keen to enhance their prevention services, particularly for

PLWHA. We expect to support the adaptation and implementation of additional, effective prevention interventions, which are tailored to the specific service being targeted (e.g. whether within a PMTCT or support group context, etc.).

A core part of the prevention packages offered to select services will focus on alcohol-HIV intersections. Drawing directly on the experience from the last year on training for health care workers on alcohol, HIV, and brief interventions that address the intersection, this project will continue to support those activities under this award. Alcohol screening, information, and interventions will be a part of the service enhancement package for this effort. Some service providers may receive training and support only in alcohol-HIV and the brief motivational interviewing intervention that targets that link, piloted in Botswana already. Others may receive training and support in both alcohol-HIV interventions and HIV prevention, disclosure, and related interventions, as appropriate. This will depend on the need and interest of that service or group of service providers.

In sum, the objective is to offer a number of services an opportunity to strengthen their prevention services in a holistic way, including not only prevention of sexual transmission in and of itself but also the prevention of HIV and AIDS associated with risky drinking.

Expert technical assistance and trainers will be secured to provide more mentoring to a local training agency to aid in carrying out the project, to speed the development and deployment of appropriate prevention strengthening intervention and material, to improve the training plan to include more follow-up and to include a process evaluation of the effort after six months of roll-out in specific major HIV-related services (still to be determined).

Table 3.3.07: Program Planning Overview Program Area: Palliative Care: TB/HIV Budget Code: HVTB Program Area Code: 07 Total Planned Funding for Program Area: $ 4,062,116.00

Program Area Context:

In 2004, there were 10,319 reported cases of TB in Botswana and the case notification rate was reported to be 566/100,000, among the highest in the world. The directly observed therapy (DOT) strategy, adopted by the Ministry of Health (MOH) in 1993, has been implemented in all 24 health districts, though progress towards the Millennium Development Goals for case detection (70% of new smear-positive cases) and treatment success (85% of new cases detected) has been hampered by steadily increasing HIV rates. In 2003, the case detection rate was 66%, and although the overall success rate was estimated to be 77%, the cure rate among smear-positive patents reached only 34%.

HIV prevalence has increased dramatically since the 1990s, and UNAIDS estimates that approximately 272,000 Batswana are now living with HIV/AIDS. Rates of HIV among TB patients range from 60 to 86%. Based on these studies, MOH estimates that there are between 5,800 and 8,300 HIV-infected TB patients per year who could potentially access ARV therapy and therefore contribute to reaching the Botswana EP goal of 33,000 patients on ARV treatment by 2008. Reaching this target requires further expansion of the 4 core activities emphasized for TB/HIV programming: routine HIV testing (RHT) of all TB patients; referral of all HIV-infected TB patients to HIV care and treatment; screening of all HIV-infected patients for active TB disease; linking all HIV-infected TB suspects to TB diagnosis and DOT therapy.

Services

The Government of Botswana (GOB) recognizes that TB/HIV integration is essential. In Jan. 2004, Botswana implemented a new national policy of "routine, non-compulsory" HIV testing. The Botswana National TB Program (BNTP) was among the first programs to implement this policy. During FY06, the GOB established the Botswana National TB/HIV Advisory Committee with USG support. The Committee, comprising representatives from 15 government and local organizations, met 3 times this year to develop terms of reference to improve service integration and collaboration on policy issues regarding care and treatment of co-infected persons.

In FY06, the USG supported a wide range of TB/HIV collaborative activities. In an effort to increase RHT among TB patients and to support recording and reporting (R&R) systems, HHS/CDC Atlanta assisted BNTP to develop a TB/HIV training curriculum for health care workers at the district- and facility-levels. Twelve hundred medical officers, nurses and family welfare educators were trained during the last year through this effort. At the same time, the BNTP began implementing new TB registers, patient treatment cards and reporting forms that now include patient-level TB/HIV data. The national electronic surveillance system (ETR.NET) has been modified accordingly to collect these elements. These data, which include HIV status, receipt of ARVs and Isoniazid Preventive Therapy (IPT), are essential to measure achievement of EP goals.

Isoniazid preventive therapy (IPT) is recommended to reduce TB-associated morbidity and mortality in PLWHAs. Botswana is the first African country to implement a national IPT program for PLWHAs. The program also effectively functions as a gateway for both HIV and TB treatment. The goals of Botswana's IPT Program are to screen all HIV-infected persons for active TB and prevent the development of active TB by providing patients with 6 months of daily isoniazid. TB suspects identified during the screening process are referred to the TB program for evaluation and ARV treatment if indicated. The IPT program was piloted in 2000-1 and rolled out nationally in 2004. To date, more than 40,000 HIV-infected patients have been registered in the IPT program. Of 642 public health facilities in Botswana, 636 offer IPT. While highly effective in clinical trials settings, IPT's efficacy for HIV-infected persons under routine conditions has not been evaluated; this activity is slated for FY07.

Referral and linkages A cross-sectional survey of RHT in 2005 among registered TB patients found that 47% of TB patients had a recorded HIV test result; approximately 9% of these patients were documented to be concurrently

receiving ARV treatment. Preliminary data from 2006 indicate that although HIV testing has increased to 68%, the proportion of eligible TB patients on ARVs remains low. Further support is needed to achieve universal HIV testing of TB patients and to strengthen referral systems for PLWHA. Approximately 30% of staff reported not being trained to perform rapid HIV tests, and consequently must "refer" TB patients for HIV testing. Human resource shortages and inadequate supervision at the district-level remain obstacles.

Global Fund Against AIDS, TB and Malaria (GFATM) and WHO. GOB is waiting to sign the fifth round funding for TB activities. The GFATM proposal focused on 4 objectives for completion by the end of 2007: 1) scaling up community TB care; 2) increase treatment success rate under DOTS to 85%; 3) strengthen TB/HIV collaborative activities; and 4) strengthen supervision, monitoring and evaluation. Funds from this round will be released contingent upon GOB personnel action. WHO/AFRO provides approximately 90K/year to MOH for general support of DOTS strengthening, and community TB care. No other major donors support TB/HIV activities in Botswana.

Policy

BNTP Program Review. In early 2006, experts from WHO, International Union Against TB, Lung Disease (IUATLD), HHS/CDC and KNCV (Royal Netherlands Chemical Society's Tuberculosis Foundation) participated in a comprehensive TB program review. Recommendations focused on 6 areas: 1) Increasing human resource development and program strengthening supervision; 2) Improving TB/HIV integration and collaboration (including evaluation of the IPT Program); 3) Addressing the threat of drug-resistant TB (by finalizing MDR TB policy/guidelines and conducting a drug resistance survey); 4) Strengthening laboratory services (including staff-up, QA certification and equipment upgrades); 5) Intensifying partnerships and coordination across Ministries and with NGOs and other partners providing TB care; and 6) Developing a long-term development plan and resource mobilization strategy for TB Control.

Outstanding challenges and gaps

HIV patients receive care and treatment through a network of Infectious Disease Care Centers (IDCCs) operated by the national ARV program (MASA). Although the 2005 National ARV Treatment Guidelines recommend quarterly screening patients for opportunistic infections (OIs), the guidelines do not specify TB screening. As a result, no systematically collected patient-level data on the number of ARV therapy recipients who are screened for active TB or receive concurrent TB therapy in care and treatment settings are available; in addition, there are no mechanisms to record or follow-up on referrals between MASA and BNTP, despite, in many instances, the co-location of services. MASA does collect and report aggregate data on OIs, however these are inadequate to document EP targets. Cotrimoxazole preventive therapy (CPT), which is recommended for patients with CD4s < 200, is implemented by the national ARV program; CPT is not monitored by the BNTP so there are no data on the number of TB patients receiving CPT.

BNTP management recognizes that these shortcomings have serious implications for PLWHA given the high rates of coinfection among TB patients. Among these include the risk of emerging TB drug resistance which may be related to HIV, and lack of infection control in congregate settings which may contribute to the spread of TB among PLWHAs. The BNTP is receiving technical assistance from WHO to revise its TB Program and Infection Control Manuals. BNTP has also allocated funds to address human resources shortages and will be hiring 20 new full time health educators/nurses as district-level TB coordinators in FY06.

Program Area Target: Number of service outlets providing treatment for tuberculosis (TB) to 14 HIV-infected individuals (diagnosed or presumed) in a palliative care setting Number of HIV-infected clients attending HIV care/treatment services that are 450 receiving treatment for TB disease Number of HIV-infected clients given TB preventive therapy 2,700 Number of individuals trained to provide treatment for TB to HIV-infected 706 individuals (diagnosed or presumed)

Table 3.3.07:

07-C0911: AED- Strengthening Prevention in clinical and community settings.

This activity has USG Team Botswana Internal Reference Number C0911. This activity links to the following: C0612 & C0616 & C0901 & C0908 & P0103 & P0513. This activity provides complementary funding to this activity, for a total program budget of $200,000.

Background This activity involves strengthening prevention services in clinical and community services. With FY06 funding, we are supporting an assessment of the opportunities to strengthen prevention messages and services in relevant clinical and community services for PLWHA and to pilot test a set of tools targeting health care providers in ARV and/or HIV testing sites which help them more systematically provide HIV prevention messages to patients. The tools were initially developed at CDC headquarters, and are now offered to all countries to adapt and implement as appropriate. So the program will be supplemented by support from staff at CDC headquarters, through assistance with training and other technical advice.

The program was awarded late in FY06 to AED, so we do not have the results of that assessment to inform this activity. However, we expect that activity to identify numerous areas where we can provide additional training, materials, and other supportive materials to strengthen prevention services for PLWHAs and other clients of those services. Priority sites include 1) lay and professional counselors who provide HIV testing and other post-test services, including at Tebelopele 2) ARV site health care providers, and/or 3) community home-based care workers. Given the readiness within Tebelopele to reassess its prevention services protocols, we anticipate at this stage that the initial focus of the assessment's follow-up activities will be in counseling and testing sites, both free-standing VCT and the routine testing program.

Focus on HIV testing sites and protocols With this in mind, the activity in FY07 aims at strengthening HIV prevention messages for clients who test HIV positive and those who test negative in the VCT settings. The Tebelopele VCT centers, BOCAIP and other CBOs/NGOs/FBOs would be the venues for this intervention. Currently clients testing especially at the Tebelopele centers test anonymously and do not often return for supportive counseling. During FY07 Tebelopele will transition from anonymous to confidential VCT service delivery, and is planning to provide on-going risk reduction and supportive counseling to its clients. However, there is no protocol for use by counselors in conducting follow up prevention counseling. CDC has developed an information package for HIV prevention in care and treatment settings. However, it should be noted that VCT settings provide a great opportunity for HIV prevention counseling for clients including discordant couples. There is need to pilot and adapt these materials in the VCT settings in Botswana, and also to develop a concise HIV prevention package for HIV negative clients for the first and follow-up visits. There are growing concerns in the community that clients testing HIV negative are often not referred to any on-going HIV preventive services, and yet they may be at high risk of infection. These funds will support a contractor to be determined to work collaboratively with VCT staff, HHS/CDC/HHS/CDC/BOTUSA and HHS/CDC Atlanta to develop, pilot and adapt these targeted prevention messages or protocols. This activity also includes providing the necessary training to VCT staff during pilot, adaptation and roll out of the intervention.

It has also become necessary to review the current VCT protocol for same-day results at the VCT centers, to adapt them to the changing needs of clients and to be consistent with the changing strategies for counseling and testing in Botswana. The introduction of RHT in 2004 changed the counseling procedure in the public health setting. Pre-test counseling is not a prerequisite for testing. However, the VCT centers have maintained a lengthy pre-test protocol, even for repeat testers. Whereas the objectives of counseling and testing in these settings may be different, there now seems to be a consensus among VCT providers that the protocol needs review, to allow for a more targeted, "rapid counseling" protocol. In the traditional protocol, a counselor should see 8 clients a day. This standard is an impediment for the rapid scale up of VCT services to meet the ever rising demand. Some busy VCT centers usually turn away clients as a result. A shortened pre-test counseling or "pre-test group education" protocol, with a concise, targeted post-test protocol is now required. In addition, the implementation of the HIV prevention package for clients will necessitate the revision of the VCT protocol. A contractor to be determined

working with the key stakeholders and with technical assistance from HHS/CDC Atlanta will review the existing VCT protocol. Funds will also cover training of staff on the use of the revised protocol, as well as producing copies of the protocol for all counselors.

Other PLWHA services targeted for prevention strengthening If funding allows, some effort in this program may go to other services besides HIV testing sites, to strengthen prevention for PLWHA there. The assessment will identify additional services and groups, like Tebelopele, that are keen to enhance their prevention services. We hope to begin to follow up with such services and organizations under this initiative too, though the majority of the effort will remain on HIV testing sites in this fiscal year.

The New Prime Partner will be Academy for Educational Development. HHS/CDC has awarded a contract for a Counseling and Testing Outreach program that includes funds from COP06 and COP07. This activity is the last remaining funding allocation to be made.

Table 3.3.09:

These funds will supplement Activity New 1 (which is a naming of the Prime Partner to AED of Activity: 10181) There is a shortfall of funds to support the 'Outreach Counseling and Testing Activity' that was awarded to AED. As a result only phase 1 of the project was funded intially. With a budget surplus in the VCT managmenet budget, we request that the shortfall in funds needed be re-programmed to the GAP 6 mechanism so the full contract can be awarded before the end of the USG fiscal year 2006.

Table 3.3.10: Program Planning Overview Program Area: HIV/AIDS Treatment/ARV Drugs Budget Code: HTXD Program Area Code: 10 Total Planned Funding for Program Area: $ 11,855,187.00

Program Area Context:

Since January 2002, the Government of Botswana (GOB) has been providing free antiretroviral (ARV) treatment to people living with HIV/AIDS (PLWHAs). This program started with one site and has grown over the years to the current 32 sites with approximately 68,440 (as of June 2006, inclusive of the private sector) patients currently on treatment.

Government units involved in the provision of ARVs include the Ministry of Health's (MOH) Drugs Regulatory Unit (DRU), which registers the medications, the National Drug Quality Control Laboratory (NDQCL) which provides quality control, and Central Medical Stores (CMS), which handles procurement and distribution.

The program is faced with constraints such as lack of human capacity in the following areas: 1) ARV logistics, 2) ARV quality control, 3) ARV security infrastructure, 4) ARV registration, and 5) ARV procurement. Since Botswana has no pharmaceutical manufacturing facilities, all medicines are imported.

Botswana has received assistance from the Bill and Melinda Gates Foundation, Merck Foundation, Glaxo-Smith Kline, Boerhinger Ingelheim, and Pfizer in the form of donations of ARVs, medicines for treatment of opportunistic infections (OI), and ARV price reductions.

With fiscal year (FY) 05 Emergency Plan (EP) funds, the United States Government (USG) contributed approximately 13% of the total Botswana Government budget for procurement of ARVs drugs. The funds were used in a variety of ways. In addition to drug procurement (adult and pediatric), a security system was installed at CMS and at the adjacent warehouse. Funds were also used to pre-qualify suppliers, which reduced the time to purchase medicines and related medical products. Text books containing official test methods for ARVs and OI drugs were purchased for NDQCL and CMS, and ARV and OI drug primary reference standards were procured for NDQCL. Vehicles were purchased to assist in the local inspections of pharmaceutical operations, a document management system was developed for DRU and study tours for Good Manufacturing Practices (GMP) inspections in three different countries were conducted. A pharmacovigilance section was established and training of health care providers on reporting of adverse drug reactions was set up. CMS was renovated to improve the storage area and the air conditioning system.

With FY06 EP funds, 322 pharmaceutical supply officers and health care auxiliaries will be trained in supply chain management (both at CMS and health facilities countrywide). This will improve staff efficiency and effectiveness. Examples of these trainings are: 1) six officers to be trained in pharmaceutical analysis, 2) ten to be trained in ISO/IEC 17025 standards to develop a quality management system, 3) five officers to be trained in evaluation of new drug applications, 4) eight officers to be trained in GMP, 5) nine officers to be trained in pharmacovigilance, 6) nine officers to be trained in inspections of active pharmaceutical ingredients manufacturers, 7) seven officers to be trained in advanced pharmaceutical analysis and 8) three officers to be trained in quality control through practical attachments at ARV manufacturing sites.

In FY07, the GOB will continue to strengthen the procurement and distribution of ARVs and other medicines. Sixteen percent of the total GOB budget for ARVs will be provided from the proposed FY07 funds. FY07 funds will 1) increase the procurement of pediatric formulations, 2) strengthen the supply chain by hiring skilled personnel, and 3) develop and implement quality management systems for CMS and DRU. Of the total funding for ARV drugs ($13,871,536), 91% will be used for drug procurement; 11.7% of the funds for ARVs will be used to purchase pediatric drug formulations (US $1.5 million).

a. In FY07, training on pharmacovigilance will continue to empower practitioners to report adverse drug reactions and to ensure that successive procurements of the drugs are safe and bio-effective. GMP inspections of manufacturers will also continue. These inspections will facilitate the registration of generic

ARVs. A new activity in FY07 is that the Supply Chain Management System (SCMS) will provide technical assistance and support to CMS and various units for the development of modern logistics practices and technologies to efficiently carry out its responsibility of procurement, quality assurance, storage and distribution of HIV/AIDS related commodities for all government, mission, mine and non-government organizations in Botswana.

In addition, the funds will continue to strengthen the quality control of ARVs and drugs to treat HIV-related OIs through advanced training in pharmaceutical analysis, and procurement of textbooks and ARV primary reference standards. The funds will also be used to fund study tours to assess the Laboratory Information Management Systems (LIMS) that will be installed in the new NDQCL facility. This system will be linked to DRU for easy access to test results.

Quality assurance at CMS will also be strengthened by providing training for internal auditors to conduct regular internal audits. The distribution system will be improved through the purchase of two self-loading trucks and installation of self-loading mechanisms in the current fleet. CMS will also procure two refrigerated vehicles for distribution of refrigerated medications and other products.

Table 3.3.10: