Male Circumcision: Policy & Programming - PowerPoint Presentation

Slide1

Male Circumcision: Policy & Programming

Ensuring QualitySlide2

Knowledge Check

Answer the following questions to see how much you know about this topic.

Government and program requirements for making male circumcision safe include all of the following EXCEPT:

Use of appropriate and sterile surgical equipment

Trained providersDemonstrated provider competency in all three WHO-described male circumcision techniquesAdequate postoperative careA referral system in place for serious complicationsResearchers have concluded that in the context of a randomized controlled trial male circumcision results in INCREASED HIV risk behavior.TrueFalse

According to a study in Rakai, Uganda, on optimizing provider skills after male circumcision training: (Select the BEST answer.)

Adverse events were higher immediately after training

Additional supervision is needed for at least the first 20 procedures after completing training

Male circumcision skills do NOT improve over time

a and bSlide3

Knowledge Check (continued)

Answer the following questions to see how much you know about this topic.

The biggest barriers to male circumcision among potential clients include all of the following concerns EXCEPT:

Cost

SafetyEffectivenessPainPEPFAR-funded programs will need to report all of the following male circumcision indicators EXCEPT:Number of males circumcisedNumber of circumcised clients experiencing at least one moderate or severe adverse event

Number of HIV-positive men who request circumcision

Number of health care workers who successfully complete an in-service training program

Percentage of males in the population circumcisedSlide4

Quality Assurance: Quality Is Very Important.

In establishing male circumcision (MC) services, country programs will need to ensure that quality assurance standards are in place. This will require a standard definition of quality for the health system or program, a standard way to measure quality, and guidance for improving quality.

Goals for all MC programs should include:

Safety

Provision of a minimum package of servicesEfficiency and productivityHighlights: Volume should not supersede quality.

Did You Know?

Human rights, legal, and ethical principles must guide service delivery. See the WHO and UNAIDS guidance on

the

human rights approach

.

Source

: WHO and UNAIDS 2007bSlide5

MC: A Combination HIV Prevention Strategy

The World Health Organization (WHO)

recommends that the following

minimum package of services be delivered when MC is implemented:1. HIV testing and counseling*2. Active exclusion of symptomatic sexually transmitted infections (STIs); syndromic treatment where required3. Provision and promotion of male and female condoms4. Counseling on risk reduction and safer sex*5. MC surgical procedures performed as described in the Manual for Male Circumcision under Local Anaesthesia

.

(WHO, UNAIDS, and Jhpiego 2009)

*Counseling will be addressed in the Communication, Counseling, Demand Generation session.Slide6

What Are the Risks of MC?

Despite the multiple benefits that medical MC can provide,* as with any surgical procedure, there are potential

risks. Any

problems with MC

(see next slide) usually occur during or soon after the procedure.However, these complications are rare when MC is performed by well trained, adequately equipped, experienced health care providers, and they are usually resolved rapidly and easily.In fact, the greatest direct risk surrounding the procedure is NOT abstaining from all sexual activity for six weeks after MC while the wound heals. During this time the risk of HIV infection may actually be higher: HIV-negative men may be more likely to get infected, and HIV-positive men may be more likely to transmit HIV to their partners.

*Multiple benefits of MC are described earlier in this course. See

Compelling Evidence – Protection

Against

HIV

and

Other Benefits for Men and Women

.Slide7

What Are the Risks of MC? (continued)

Problems may include

:

Pain

BleedingHematoma (formation of a blood clot under the skin)Infection at the site of the MCIncreased sensitivity of the glans (head) of the penis for the first few months after the procedureIrritation of the glans

Meatitis (inflammation of the opening of the

urethra

)

Painful or difficult urination

Injury to the penis

Adverse reaction to the anesthetic used during

surgery

Did You Know? Data from controlled trials show that fewer than 1 in 50 medical MC procedures result in complications.

Source: Krieger et al. 2005; Auvert et al. 2005; WHO, UNAIDS, and Jhpiego 2009Slide8

Safety of the Medical MC Procedure Can Be Assessed by Low Adverse Event Rates.

Although

adverse events (AEs)

– bleeding, formation of a blood clot under the skin, infection, severe pain, and painful or difficult urination – were reported during MC trials in Uganda and Kenya, the rates of these events declined over time as the providers became more proficient.

Programs can use the Sample MC AE Form (WHO, UNAIDS, and Jhpiego 2009) to assess and record AEs.Did You Know?The biggest barriers to MC among potential clients are cost, concerns about safety (risk of infection or mutilation), and pain.Slide9

Safety of the Medical MC Procedure Can Be Assessed by Low Adverse Event Rates. (continued)

Highlights: AE

rates are low in MC settings that provide ample resources and plenty of training.

Rate of AEs Related to the Intervention in the Three Randomized Controlled Trials (RCTs)

Orange Farm, South Africa: 60 AEs (3.8%)Kisumu, Kenya: 21 AEs (1.5%); resolved quicklyRakai, Uganda: 84 moderate or severe AEs (3.6%); all resolved with treatmentSlide10

Making MC Safe

Safe MC

Requirements

Use of appropriate and sterile surgical

equipmentTrained providersA hygienic operating environmentAdequate counseling, education, and postoperative careA referral system in place for serious complications

MC training in Namibia

The government and programs should ensure that MC is carried out safely.Slide11

Making MC Safe (continued)

MC safety depends upon training that includes:

A focus on competency demonstrated by successful completion of

standardized

MC checklists (WHO, UNAIDS, and Jhpiego 2010a)Demonstrated competency in one of the three WHO-described MC techniques (forceps-guided, dorsal slit, or sleeve resection)Did You Know?“Two-thirds of African men are circumcised

–

most by traditional or unqualified practitioners in informal settings.

“Safety of circumcision in communities where it is already widely practiced must not be ignored.”

Source

: Bailey, Egesah, and Rosenberg 2008Slide12

Minimizing the Potential for Increased Risk Behavior after MC

Ideas

in Action

The flyer,

pictured on the left, was distributed during the Tanzania MC campaign. It provided postoperative MC information and promoted post-procedure abstinence.The flyer also linked clients to an emergency hotline in case they experienced AEs.Slide13

Minimizing the Potential for Increased Risk Behavior after MC (continued)

Concern has been raised that if circumcised men believe MC confers substantial or complete protection against HIV infection, they may engage in increased risk behavior (e.g., resuming sex before wound healing, discontinuing condom use, increasing the number of sexual partners).

The three MC RCTs in South Africa, Kenya, and Uganda found no consistent evidence of any substantial increase in sexual risk-taking behavior following MC

.Slide14

Minimizing the Potential for Increased Risk Behavior after MC (continued)

A separate study (Mattson et al. 2008) of men enrolled in the Kenyan RCT measured and analyzed a comprehensive set of sexual behaviors. This study concluded that in the context of an RCT, circumcision did not result in increased HIV risk behavior. In fact, both circumcised and uncircumcised men significantly reduced their HIV risk behavior from baseline to six months and twelve months post-enrollment.

However, continued monitoring and evaluation of behavioral disinhibition and risk compensation associated with MC are needed to support this conclusion as MC becomes more widely promoted for HIV prevention.

In addition, ongoing MC education, counseling, and outreach to clients and their partners are key to minimizing high-risk sexual behavior post-MC

. See Education and Counseling for MC Clients in the Communication, Counseling, Demand Generation session.Slide15

Human Resources: Appropriately Trained Non-Physician Providers Can Perform MC.

An MC provider and site manager at Tosamaganga Mission Hospital, Iringa, Tanzania

Conventional service models in various countries utilize one

surgeon*

to perform a maximum, on average, of eight to ten MCs in one day.Health systems in developing countries are relatively weak; they have a critical shortage of skilled health workers.Source: Adapted from WHO 2010

*

In this course, the term

surgeon

refers to the person on the MC surgical team who does the cutting. This could be an appropriately trained doctor, nurse, or clinical officer.Slide16

Human Resources: Appropriately Trained Non-Physician Providers Can Perform MC. (continued)

So, it is necessary to optimize the time of highly qualified health personnel (e.g., surgeons).

Other non-physicians who have been appropriately trained are able to provide a number of surgical procedures (e.g., cesarean section, mini-laparotomy, no-scalpel vasectomy).

In Kenya and Zambia, clinical officers (non-physician clinicians) and nurses have been trained in adult/adolescent MC techniques.

WHO recommends that countries should identify non-physician providers who can be trained to perform MC.Source: Adapted from WHO 2010Slide17

Ten Quality Assurance Standards for MC

1. An effective management system established to oversee the provision of MC services

2. A

minimum package of MC services

provided3. Necessary medicines, supplies, equipment, and environment at the facility for providing safe MC services of good quality4. Qualified and competent providers5. Information and education on HIV prevention and MC provided to clients6. Assessments performed to determine client's condition7. MC surgical care delivered according to evidence-based guidelines8. Infection prevention and control measures practiced

9. Continuity of care provided

10. Monitoring and evaluation system established (This system should include thorough documentation/recording and reporting.)Slide18

Why Include External Quality Assurance (EQA)?

Highlights

An

EQA assessment

can:Provide unbiased guidance for service delivery improvementCreate incentives for clinics to align services with national standards

Complement

quality

assurance self-assessment

*

Promote public recognition and confidence in MC services

provided

Source

: PEPFAR

2009a

*

WHO’s MC Quality Assessment Toolkit

can

be used for self-assessment and EQA assessment. A complementary EQA assessment, developed by PEPFAR through the Centers for Disease Control and Prevention (CDC), was piloted in Kenya in 2009

.Slide19

Training Competent MC Providers Is Key to Quality Assurance.

MC Training Goals

Influence in a positive way the attitudes of participants to MC

Provide

participants with the knowledge and skills they need to provide MC and to provide other reproductive health counseling and servicesProvide participants with the knowledge and skills they need to establish or improve infection prevention practices at health facilitiesSlide20

Training Competent MC Providers Is Key to Quality Assurance. (continued)

MC Learning Objectives

Enable participants to:

Describe the relationship between MC and HIV infection

Link MC to the provision of other male sexual and reproductive health servicesEducate and counsel adult and adolescent clients about MCEffectively screen clients for MCDemonstrate competency in one of three surgical methods of adult/adolescent MCProvide postoperative care following MC and identify and manage AEs resulting from MC

Prevent infection in the health care setting

Monitor, evaluate, and supervise an MC serviceSlide21

Using Standardized Checklists to Measure MC Competency

Competency is measured using

standardized checklists

.

See practice checklists for group education on MC and male reproductive health; individual counseling on MC and male reproductive health; screening of clients and preparation for MC; checklists for forceps-guided, dorsal slit, and sleeve resection MC procedures; 48-hour postoperative review. (WHO, UNAIDS, and Jhpiego 2010a)Did You Know?In competency-based training, MC providers are trained on anatomic models to achieve competency before

they perform the procedure on a client.Slide22

Using Standardized Checklists to Measure MC Competency (continued)

The number of procedures required to achieve competency will vary from person to person.

To assure quality, new MC providers are supervised by experienced MC providers.

In Tanzania, anatomic models were used as part of competency-based training for medical MC.Slide23

Optimizing Skills after MC Training

Competency

(as discussed on the previous

two slides)

is measured as the ability to perform a skill according to a standardized checklist.Different providers take a longer or shorter time period/number of cases to achieve competency. Highlights: To assure quality, continuous and supportive supervision for MC providers is important during and after training.

Did You Know?

WHO and UNAIDS recommend that programs establish

supervision systems for quality assurance

along with

referral systems to manage AEs and complications

.

Source

: WHO and UNAIDS 2007bSlide24

Optimizing Skills after MC Training (continued)

Conclusion

: Additional supervision is needed for at least the first 20 procedures after completing training.

Source

: Kiggundu et al. 2009The study from Rakai, Uganda, described on this slide, can give insight into average time to achieve competency for program planning purposes

.

In Rakai, Uganda, Kiggundu et al. assessed numbers of adult MC procedures required to optimize MC provider skills after training. As the graph 

on the left illustrates

, AEs were higher immediately after training. Slide25

Infection Prevention

Hand hygiene in Iringa, Tanzania

MC scale-up will result in increased numbers of MC clients and will require an increased number of staff. Staff and clients will be close to one another in an area of increased biohazards and infectious wastes. So, as in all clinical settings, close attention must be paid to infection prevention precautions.

Highlights:

Infection Prevention Considerations

The MC surgical team should wear personal protective equipment including a clean apron, eye and mouth protection, and a surgical cap. The apron should be changed between procedures,

if soiled

.

Usually a full scrub is performed in the morning and after

lunch.

Handwashing

with an alcohol-based handrub is acceptable between cases as an alternative to a full surgical

scrub.

Source

: Adapted from WHO 2010Slide26

Infection Prevention (continued)

The WHO quality assurance guide and quality assessment toolkit address infection prevention in MC for HIV prevention settings.* The recommendations in these documents should be closely followed. For example:

Infection prevention and control policies should be available

Infection prevention and control measures should be practiced according to policy and procedures

Individuals should be designated who are accountable for infection control activities at the facilitySource: WHO 2010

*Urls for

these

online WHO documents are available on

the slide 11 notes page in the Key Resources PowerPoint session

.Slide27

PEPFAR Indicators

PEPFAR has established a standardized system of MC indicators, which can help assure quality by monitoring AEs and postoperative care, promoting MC service delivery as part of a minimum package of HIV prevention services, documenting health care worker training, and supporting national standards

.

Source

: PEPFAR 2009bDid You Know?Monitoring and Evaluation (M&E)

When M&E costs are cut, MC programs may be unable to attribute the quality and effectiveness of their programs

.Slide28

PEPFAR Indicators (continued)

The following five

MC indicators

will need to be

reported by PEPFAR-funded programs:Number of males circumcised as part of the minimum package of MC for HIV prevention services within the reporting periodNumber of circumcised clients experiencing at least one moderate or severe AE* during or following surgery, within the reporting periodNumber of locations providing MC surgery as part of the minimum package of MC for HIV prevention services within the reporting periodNumber of males circumcised within the reporting period who return at least once for postoperative follow-up care (routine or emergency) within 14 days of surgeryNumber of health care workers who successfully completed an in-service training program

Source

: PEPFAR 2009b

*See the

Sample MC AE Form

(WHO

, UNAIDS, and Jhpiego 2009). It is a helpful job aid that can be used for recognizing and categorizing AEs, rating their severity (mild, moderate, severe), and recording those that occur during and after surgery.Slide29

PEPFAR Indicators (continued)

In

addition, the following

two indicators

need to be reported by the national government:Number of males circumcised per national standards within the reporting period (regardless of funding source)Percentage of males in the population circumcisedSource: PEPFAR 2009b

Did You Know?

It

is important to have an M&E system in place to track and provide accurate documentation of AEs that occur during or following surgery

.

MC program managers will need to ensure that a system is put in place to monitor and manage AEs as they occur

.Slide30

Knowledge Recap

Answer the following questions to see how much you know about this session.

Government and program requirements for making male circumcision safe include all of the following EXCEPT:

Use of appropriate and sterile surgical equipment

Trained providersDemonstrated provider competency in all three WHO-described male circumcision techniquesAdequate postoperative careA referral system in place for serious complicationsResearchers have concluded that in the context of a randomized controlled trial male circumcision results in INCREASED HIV risk behavior.TrueFalse

According to a study in Rakai, Uganda, on optimizing provider skills after male circumcision training: (Select the BEST answer.)

Adverse events were higher immediately after training

Additional supervision is needed for at least the first 20 procedures after completing training

Male circumcision skills do NOT improve over time

a and bSlide31

Knowledge Recap (continued)

Answer the following questions to see how much you know about this session.

Male circumcision is a stand-alone procedure for prevention of HIV infection.

True

FalseThe biggest barriers to male circumcision among potential clients include all of the following concerns EXCEPT:CostSafetyEffectivenessPain

PEPFAR-funded programs will need to report all of the following male circumcision indicators EXCEPT:

Number of males circumcised

Number of circumcised clients experiencing at least one moderate or severe adverse event

Number of HIV-positive men who request circumcision

Number of health care workers who successfully complete an in-service training program

Percentage of males in the population circumcisedSlide32

Ensuring Quality

Knowledge Recap Answer Key

Government and program requirements for making male circumcision safe include all of the following EXCEPT:

c. Demonstrated provider competency in all three WHO-described male circumcision techniques Governments and programs should ensure that male circumcision providers have demonstrated competency in ONE of the three WHO-described techniques (forceps-guided, dorsal slit, or sleeve resection).Researchers have concluded that in the context of a randomized controlled trial male circumcision results in INCREASED HIV risk behavior.

b.

False: Researchers have concluded that in the context of a randomized controlled trial male circumcision DOES NOT result in increased HIV risk behavior. Research suggests that, in the context of a comprehensive package of HIV prevention services, HIV risk behaviors may well decline.

According to a study in Rakai, Uganda, on optimizing provider skills after male circumcision training: (Select the BEST answer.)

d.

a and b

Please note that the questions and answers match those in the

Knowledge Recap

. The number and order of questions in the

Knowledge Check

may differ.Slide33

Ensuring Quality

Knowledge Recap Answer Key (continued)

Male circumcision is a stand-alone procedure for prevention of HIV infection.

b. False: Male circumcision is a combination HIV prevention strategy. A minimum package of services should be delivered when male circumcision (MC) is implemented: 1. HIV testing and counseling 2. Active exclusion of symptomatic sexually transmitted infections (STIs); syndromic treatment where required 3. Provision and promotion of male and female condoms

4. Counseling on risk reduction and safer sex

5. MC surgical procedures performed according to WHO-described techniques

The biggest barriers to male circumcision among potential clients include all of the following concerns EXCEPT:

c.

Effectiveness

PEPFAR-funded programs will need to report all of the following male circumcision indicators EXCEPT:

c.

Number of HIV-positive men who request circumcision

Please note that the questions and answers match those in the

Knowledge Recap

. The number and order of questions in the

Knowledge Check

may differ.