Voluntary Medical Male Circumcision PEPFAR South Africa through USAID VMMC Partners Meeting

Voluntary Medical Male Circumcision PEPFAR South Africa through USAID VMMC Partners Meeting Emmanuel Njeuhmeli, MD, MPH, MBA Senior Biomedical Prevention Advisor Co-Chair PEPFAR Male Circumcision Technical Working Group Office of HIV/AIDS / US Agency for International Development

Voluntary Medical Male Circumcision for HIV Prevention

Scientific Evidence Over 50 studies to date, most of them in Africa • Epidemiological • Biological • Inner membrane surface of the foreskin highly vulnerable to HIV infection • Up to nine times more vulnerable than cervical tissue • Three RCTs • South Africa, Uganda and Kenya Strong association between • Lack of male circumcision • Higher risk of heterosexual (female-to-male) HIV transmission • MC has a strong protective effect against HIV acquisition. • Estimated by WHO/UNAIDS to be around 60%

Male Circumcision Target Countries

20,373,693M adult 15-49 years men to be circumcised across all 14 countries

Cumulative Number and Percentage of HIV Infections Averted between 2011 to 2025 by scaling up MC

Indirect Impact on women

Importance of the Implementation Coverage • Decreasing the MMC coverage target from 80% to 50% results in a • decline in the number of HIV infections averted from 3.4M to 1.1M • In Zimbabwe from 41.7% of new HIV infection averted to 23.6% of new HIV infection averted • On the other hand, increasing target MMC coverage from 80% to 100% results in • an increase in the number of HIV infections averted from 3.4M to 5M • In Zimbabwe from 41.7% of new HIV infection averted to 50.5% of new HIV infection averted

Importance of the Implementation Pace • Also as expected, reducing the time to achieve 80% MMC coverage from 5 years to 1 year leads to • an increase in the number of HIV infections averted from 3.4M to 4.1M • In Swaziland, from 33.9% of new HIV infection averted to 41.5% of new HIV infection averted • a decrease in the cost per HIV infection averted, • and an increase in net savings per HIV infection averted. • Increasing time to achieve 80% MMC coverage from 5 years to 10 or 15 years does the reverse. • In Swaziland, 23.6% of new HIV infection averted for 10 years implementation

Number of MC needed per Infection Averted from 2011 to 2025

Number MC done as off April 2011

Achievement toward Target of 80% coverage

Voluntary Medical Male Circumcision Quality Assurance

Quality Assurance (QA)? QA is the process of evaluating a program or system against known and accepted standards • Define quality • Provide basis for measuring – and recognizing – quality • Provide guidance for improving quality Goals of quality with MC include: • Safety • Efficiency and productivity to achieve impact on HIV incidence (MC as a public health intervention) • Provision of a minimum package of services in addition to surgery

External Quality Assurance (EQA) for MC? • Provides objective assessment to guide improvements • Creates incentives for clinics to align services with national standards and donor guidelines • Facilitates achievement of MC service targets • Complements WHO QA self-assessment tool • Promotes public recognition and confidence in the MC services provided

PEPFAR Standards for MC In addition to public health impact and efficiency, PEPFAR’s standards focus on • SOPs, guidelines, policies • Facilities, supplies and equipment • Clinical record keeping; monitoring and evaluation • Minimum package of services and linkages • Staffing • Surgery, including pre- and post-op and follow-up care • Communication to Clients • Waste management

Voluntary Medical Male Circumcision External Quality Assurance in South AfricaPreliminary Findings Emmanuel Njeuhmeli, MD, MPH, MBA Senior Biomedical Prevention Advisor Co-Chair PEPFAR Male Circumcision Technical Working Group Office of HIV/AIDS / US Agency for International Development

Preliminary Findings • This assessment was for VMMC Site supported by USAID only • 14 sites was visited • 5 in Gauteng • 1 Free State • 2 in KwaZulu-Natal • 6 in Mpumalanga • 5 Partners supporting those sites • CHAPS for 2 sites • Right to Care for 7 sites • MATCH for 2 sites • ANOVA for 2 sites • PHRU/ANOVA for 1 site • Sites were • Hospitals Public and Private • NGO

PEPFAR Standards for MC In addition to public health impact and efficiency, PEPFAR’s standards focus on • SOPs, guidelines, policies • Facilities, supplies and equipment • Clinical record keeping; monitoring and evaluation • Minimum package of services and linkages • Staffing • Surgery, including pre- and post-op and follow-up care • Communication to Clients

Findings (1) • Not all sites have all the SOP, Guidelines, Policies and records in place • Patient Rights Policies • Staff Job Description • Personnel files • Inform Consent Process Guidelines • HIV/AIDS Counseling and Testing Guidelines • STI Guidelines • Supplies and Equipment Inventory/Reports • Medication Inventory List • Emergency Guidelines • Waste Management Guideline and SOPs • Quality Control Register for HIV Tests • Equipment maintenance registers • Infection Prevention and Control Policies and Procedures • MC Surgery Guidelines • Complications/AE management Guideline • Other M&E Tools

Findings (2) • Most partners don’t have those documents at site level but keep them in their office and we have not seen them • Some sites have developed their own SOP, guideline documents and those adaptation does not translate accurately the NDOH guidelines

Challenges • Lack of specific National guidelines that sites can use or refer to and this lead each partners to develop their own guidelines • Lack of WHO adverse event management guidelines • Where national guidelines are existing , they are not being present at site level, for example • STI • HTC National guideline • Waste management

Recommendations • Partners should use existing guidelines from WHO, NDOH • Partners should work with PEPFAR and the NDOH to fill the gap on guidelines that are not developed yet

Findings • Most facilities have adequate and dedicated space for male circumcision • Sites are using existing supply chain management for supplies and equipment • We were not able to assess the Hospital SCMS • We found them to be adequate in most sites • Site keep limited stock of supplies in some sites just for one week and we have reported stock out of some supplies in some sites • Some site lack of equipments • Chairs for the waiting room, group counseling • TV in the group counseling, waiting room and recovery room

Recommendations • Dedication of space for VMMC is critical for site efficiency and to reach public health impact with this intervention • Site space needs to be designed in respect of client flow as described by WHO MOVE document • Sites need to have adequate equipment • Sites need to keep stock for at least one month to avoid stock out

Findings (1) • All clinics keep records of the VMMC services provided • In two MMC clinics, the client records were not kept on site • Majority of the clients (>88% on average) are above the age of 15. • In VMMC clinics on average 5% of clients test positive for HIV. • Completeness of records ranges from 70% for client history and physical examination to 100% for clients demographic information.

Findings (2) • The type of procedures performed in all the MMC clinics are not recorded, however clinic managers reported that forceps guided is the only surgical method used. • All sites also use diathermy for hemostasis but this isn’t recorded anywhere in the clients charts reviewed. • Consent forms are missing in 10% of clients files. • 50% of the files documented at least one follow up post circumcision. • Majority of these follow ups 75% were for clients who return to the clinic after 2 days for their first post op reviews • and 25% at the second day post MC.

Best Practices • Age of clients very well reported and most of the sites request birth certificate to verify the age of the client • Sites requesting parents or guardians to sign consent form when client are accompanied minors • Standard surgical method, use of electrocautery and definition of adverse events • One site – uses a ONE recording format that has most of the information that need to be completed for one client. This approach of having one standardized recording format that has provisions for recording demographics of the client, counseling and testing, consent, history and physical examination, surgical procedure note, post procedure follow up, adverse events recording and management, referral notes will help reduce paper work, reduce the chance of missing pages from client files and provides opportunity to have all documents in one record rather than multiple pages

Challenges • Completeness of records need to be 100% for all necessary information • Date of surgery • History and physical examination • Type of service providers • Type of surgical methods • Intro Op adverse events • Use of diathermy • Post op follow up • Adverse events • There are no standardized client record forms, HTC forms, consent forms, referrals, adverse event reporting and management forms and post operative care forms. • The absence of comprehensive monitoring and evaluation system for VMMC is pushing partners to develop their own system and tools. This makes standardized reporting and experience sharing a challenge. • In addition, the presence of multiple recording formats that are not properly introduced to service providers caused the quality of the records to be low. • The monitoring information isn’t changed into electronic formats as expected, but everything is done manually. This proves to be cumbersome and affects the completeness as well as quality of data and reports.

Issues • Standards recording and reporting tools for the national VMMC program are not available. • Client files kept outside MMC clinics. • Counseling and testing • Incomplete records in most sites • Mandatory testing in some sites • Consent Form • Missing consent signed forms in the client record in most sites • At least one MMC site had no consent form signed on client records • No records of parents or guardians consent for minors in the client records • Consent form for testing missing in client records in most sites • No provincial or national adverse events management system in place • Monitoring of adverse events • Management of adverse events

Recommendations • One monitoring and evaluation system for the VMMC program in RSA is critical to effectively monitor progress, assure safety and plan for expansion. • Recording and reporting can and should be computerized and data should be accessible for NDOH for decision making real time • Standardized recording and reporting tools needs to be developed as part of the monitoring system • Consensus amongst partners and donors on one monitoring system, orientation and training of providers on standardized tools are important considerations for the VMMC programs in RSA supported BY PEPFAR • Clients records need to be kept on site • HIV Counseling and Testing is not mandatory • Consent Forms need to be signed and kept in clients file and parents should consent for minors , consent need to be signed for testing and the surgery • Date of Surgery, history and physical examination • Need to be carefully recorded in ALL clients files • Even though type of providers, use of electrocautery and surgical methods are standard, need to be reported in client file • Adverse event • National or provincial adverse event monitoring and management system need to be design and implemented

Findings • Generally sites visited provide the minimum package of services: • HIV testing and counseling, • Risk reduction counseling, • Screening and treatment of STIs. • Only few sites refer clients for STI services outside VMMC. • Clinics Linkage to care and treatment is also implemented in different facilities at different levels. • VMMC clinics provide little or no information to women and partners about the services. • No couple counseling services are provided

Best Practices • Discovery’- clients who test positive and CD4 count below 350 are ‘escorted’ to care and treatment clinics to be enrolled. • Such active linkage between MC and other services need to be strengthened

Challenges • Follow up of clients after referral, according to most of the sites, has proved challenging. • There is no mechanism to confirm if clients actually accessed services at the receiving end of the referrals. • Especially referrals to care and treatment are not receiving feedbacks about clients. • In addition, the VMMC service has little to offer to women in the form of access to information, opportunity to access couple counseling and testing and risk reduction. • Although a couple of sites reported efforts to educate women, in general there is a lack of IEC materials that targets women and families. • Also providers are not trained to provide couples counseling in the VMMC clinic.

Issues • Clinics make decisions to circumcise clients who test positive and have a CD4 count of >200 and < 350. • While this cut off for CD4 along with clinical assessment works well in all the clinics clients who, according the national guidelines, need to be enrolled for care and treatment as a priority are lost in favor of performing circumcision. • The linkage to care and treatment after circumcision is weaker than the linkage before circumcision. clinics need to prioritize enrollment to care and treatment over circumcision.

Recommendations • Active referral system need to be design and implemented to track clients referred to other services mainly care and treatment. • Possible utilization of dedicated personnel (case manager, peer educator, expert client) to provide active referral and linkage • A recording and reporting mechanism to track and document where clients went, when they accessed services. • A simple SMS system to provide and or exchange feedbacks between referring and receiving clinics can be helpful.

Findings • No standard composition of the site staff • Most sites have staffs working 5 days a week but with variation of time per day • Physicians time is variable from part time to full time • Some of the staffs do not provide MC counseling. They were not trained

Best Practices • Very motivated, hard working and competent staff. • The site has enough number of nurses dedicated for MC. • A good number of counselors who are dedicated for all types of counseling.

Challenges • Each site have different composition of teams: MOVE team • Some sites have no dedicated physician(s) for MC clinic. • Some clinic does not open full time • Some of the staffs do not offer counseling because they were not trained • Most of the site have no data manager

Recommendations • Each site need to have a standard composition of the MC team and each MC site need to have a dedicated physicians • The ration of physician – nurse recommended in the WHO MOVE document is 1 physician for 4 fixe nurses and 1 mobile nurse for 4 clients/surgical bed • Clinic should maximize use of staff time and facility space by having either one or two surgical team • All the staffs working at the clinic need to be trained on risk reduction counseling • Each site should have a data clerk or data manager who will be responsible for data management, record keeping and reporting.

Findings • Most of the standards are met. • Mixture of Lignocaine and Marcaine is used for Local anesthesia. Standard dose is used for all clients • One artery forceps broke during procedure. • The MOVE model used by all facilities

Best Practices • MOVE model is applied. • Good surgical procedure. • Sterile techniques are followed • Attention to the client throughout of the procedure. • The surgical bays are very well arranged and all the necessary equipments and the waste bins are located at the surgical bay. This is very efficient way to minimize contamination and maintain high level of waste management.

Challenges (1) • Using the standard dose for Local anesthesia instead of weight based dosage. • No marking of the intended point of incision is done prior to the placement of forceps by some providers • The recommended vertical mattresses for 3, 9 and 12 o’ clock positions are not applied by some providers • Duration of surgery is not recorded. No clock in the surgical bay in most sites • Waste bins are very far from the surgical bays in some sites, this led the nurse to run from the surgical bay to the disposing area whenever he touches unsterile surrounding environment.

Challenges (2) • The recovery room for the clients is not clearly defined. This may lead to not providing proper post op recovery services which includes the 30 minutes observation with taking the vitals. • Diathermy’s inactive rod is handled by the client during the electrocautery. • Screening of the client is done in the surgical theatre and is brief in some sites • Hand cleaning is not standard for surgical procedure. • Only ring blocking is done while administering local anesthesia • No segregation of medical wastes at the point of origin.

Challenges (3) • Post op written instructions are not given to all clients. • Partially applied surgical techniques, such as picking up needles with fingers instead of pick up forceps. • Task sharing is not practiced in some sites. Surgeon does all steps of the procedure from injecting anesthesia to final stitches. Nurses bandage the penis.

Voluntary Medical Male Circumcision PEPFAR South Africa through USAID VMMC Partners Meeting