SOL-674-16-000034 _A01_redlined_RFP.pdf

Regional Office of Acquisition and Assistance

RFP Issuance Date: August 23, 2016 Questions Due Date: August 31, 2016 at 8:00AM, Pretoria Local Time Proposal Due Date: September 26, 2016 at 8:00AM, Pretoria Local Time

SUBJECT: REQUEST FOR PROPOSAL (RFP) No. SOL-674-16-000034, Voluntary Medical Male Circumcision (VMMC) Service Delivery III Project

To All Prospective Offerors:

The United States Agency for International Development (USAID) Mission in Southern Africa (the “Government”) is seeking proposals from qualified Offerors interested in implementing the Voluntary Medical Male Circumcision (VMMC) Service Delivery III Project.

This procurement is conducted as a full and open competition, under which all types of qualified organizations (for-profit firms, non-for-profit organizations, non-governmental organizations, including universities, research organizations, professional associations, and relevant special interest organizations) in geographic code 935 to compete. The applicable NAICS code for this acquisition is 541690.

In support of the Government’s interest in expanding the number and sustainability of development partners, USAID/Southern Africa encourages proposals from new potential partners. Please refer to the Statement of Work in Section C of this RFP for a complete statement of goals and expected results.

USAID/Southern Africa intends to award a combination (hybrid) contract with two separate contract line items (CLINs): a requirements contract line item (CLIN 0001) and a cost-plus-fixed-fee, term form contract line item (CLIN 0002). The performance period is five (5) years from the date of award, subject to the availability of funds. Offerors must propose prices and costs that are appropriate, realistic and reasonable for the accomplishment of the work specified in Section C.

This solicitation consists of this Cover Letter and the attached RFP. Offerors must read the entire solicitation. Please pay special attention to Section L – Instructions to Offerors and Section M – Evaluation Factors for Award. Sections B through J of this RFP will become the basis for the contract. Any blanks in Sections B through J will be completed by the Contracting Officer before award. Offerors must comply with FAR Clause 52.204-7, System for Award Management (SAM), and adhere to the requirements set forth in Section K – Representations, Certifications and Other Statements of Offerors.

Amendments to this solicitation will be posted on the Federal Business Opportunities website at http://www.fbo.gov. It is the Offeror’s responsibility to check this site periodically for any official updates and amendments to the solicitation. This solicitation in no way obligates USAID to award a contract, nor does it commit USAID to pay any costs incurred in the preparation and http://www.fbo.gov/

Request for Proposal (RFP) SOL-674-16-000034 Voluntary Medical Male Circumcision (VMMC) Service Delivery III submission of a proposal in response hereto. Furthermore the Government reserves the right to reject any and all offers, if such action is considered to be in the best interest of the Government.

All questions and requests for clarifications about this solicitation must be submitted in writing via email by no later than the deadline above to proposals@usaid.gov. Include the RFP number in the email subject line. Oral instructions, answers or guidance from any USAID source prior to the award of the contract will not be binding.

Sincerely, Michael Ashkouri, Esq.

Supervisory Regional Contracting Officer mailto:proposals@usaid.gov

[SF-33 in PDF]

Table of Contents

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 PURPOSE

B.2 CONTRACT TYPE

B.3 CONTRACT PRICES/COSTS AND OBLIGATED AMOUNTS

B.3.1 CLIN 0001 - REQUIREMENTS CONTRACT LINE ITEM

B.3.2 CLIN 0002 - COST-PLUS-FIXED-FEE, TERM FORM CONTRACT LINE ITEM

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 OBJECTIVE

C.2 OVERVIEW

C.3 STATEMENT OF WORK

C.4 GEOGRAPHIC LOCATION

C.5 KEY PERSONNEL QUALIFICATIONS

SECTION D – PACKAGING AND MARKING

D.1 AIDAR 752.7009 MARKING (JAN 1993)

D.2 BRANDING STRATEGY AND MARKING PLAN

SECTION E – INSPECTION AND ACCEPTANCE

E.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY

REFERENCE

E.2 INSPECTION AND ACCEPTANCE

SECTION F – DELIVERIES OR PERFORMANCE

F.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY

REFERENCE

F.2 PERIOD OF PERFORMANCE

F.3 PLACE OF PERFORMANCE

F.4 AUTHORIZED WORK WEEK (CLIN 0002)

F.5 PERFORMANCE STANDARDS

F.6 REPORTS AND DELIVERABLES OR OUTPUTS

F.7 KEY PERSONNEL

F.8 LEVEL OF EFFORT (CLIN 0002)

F.9 52.216-18 ORDERING (OCT 1995) (CLIN 0001)

F.10 CONTENTS OF ORDERS (CLIN 0001)

SECTION G – CONTRACT ADMINISTRATION DATA

G.1 AIDAR 752.7003 DOCUMENTATION FOR PAYMENT (NOV 1998)

G.2 CONTRACTING OFFICER

G.3 TECHNICAL DIRECTIONS/RELATIONSHIP WITH USAID

G.4 PAYMENT AND INVOICES

G.5 ACCOUNTING AND APPROPRIATION DATA

G.6 CONTRACTOR’S PRIMARY POINT OF CONTACT

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 USAID IMPLEMENTING PARTNER NOTICES (IPN) PORTAL FOR

ACQUISITION (JUL 2014)

H.2 LANGUAGE REQUIREMENTS

H.3 BUSINESS CLASS TRAVEL

H.4 CONTRACTOR’S STAFF SUPPORT AND ADMINISTRATIVE AND

LOGISTICS ARRANGEMENTS

H.5 CONSENT TO SUBCONTRACT

H.6 REPORTING OF FOREIGN TAXES (JUL 2007)

H.7 AUTHORIZED GEOGRAPHIC CODE

H.8 EXECUTIVE ORDER ON TERRORISM FINANCING

H.9 HOMELAND SECURITY PRESIDENTIAL DIRECTIVE -12 (HSPD-12)

(SEP 2006)

H.10 ENVIRONMENTAL COMPLIANCE (22 CFR 216)

H.11 752.222-70 USAID DISABILITY POLICY (DEC 2004)

H.12 NONDISCRIMINATION (JUN 2012)

H.13 FOREIGN GOVERNMENT DELEGATIONS TO INTERNATIONAL CONFERENCES (JAN

2002)

H.14 CONFERENCE PLANNING AND REQUIRED APPROVALS (AUG 2013)

H.15 DEFENSE BASE ACT INSURANCE AND SERVICES

H.16 USAID-FINANCED THIRD-PARTY WEB SITES (AUG 2013)

H.17 SUBMISSION OF DATASETS TO THE DEVELOPMENT DATA

LIBRARY (DDL) (OCT 2014)

H.18 PROHIBITION OF ASSISTANCE TO DRUG TRAFFICKERS

H.19 752.7101 VOLUNTARY POPULATION PLANNING ACTIVITIES (JUN 2008)

H.20 CONSCIENCE CLAUSE IMPLEMENTATION (ACQUISITION) –

SOLICITATION PROVISION (FEB 2012)

H.21 CONSCIENCE CLAUSE IMPLEMENTATION (FEB 2012)

H.22 CONDOMS (ACQUISITION) (SEP 2014)

H.23 PROHIBITION ON THE PROMOTION OR ADVOCACY OF THE

LEGALIZATION OR PRACTICE OF PROSTITUTION OR SEX

TRAFFICKING (SEP 2014)

H.24 ELECTRONIC PAYMENTS SYSTEM

H.25 CLOUD COMPUTING (MAY 2016)

PART II – CONTRACT CLAUSES

SECTION I – CONTRACT CLAUSES

I.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY

REFERENCE

I.2 52.216-21 REQUIREMENTS (OCT 1995) - CLIN 0001

I.3 52.247-67 SUBMISSION OF TRANSPORTATION DOCUMENTS FOR

AUDIT (FEB 2006)

I.4 52.203-99 PROHIBITION ON CONTRACTING WITH ENTITIES THAT

REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS-

REPRESENTATION (APR 2015)

I.5 52.216-19 ORDER LIMITATIONS (OCT 2015)

I.6 752.7032 INTERNATIONAL TRAVEL APPROVAL AND NOTIFICATION

REQUIREMENTS (APR 2014)

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J – LIST OF ATTACHMENTS

SECTION K – REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

OFFERORS

K.1 NOTICE LISTING SOLICITATION PROVISIONS INCORPORATED BY REFERENCE 69

K.2 52.204-8 ANNUAL REPRESENTATIONS AND CERTIFICATIONS (APR 2016)

K.3 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS

K.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS

K.5 52.222-56 CERTIFICATION REGARDING TRAFFICKING IN PERSONS COMPLIANCE

PLAN (MAR 2015)

K.6 52.230-1 COST ACCOUNTING STANDARDS NOTICES AND

CERTIFICATION (OCT 2015)

K.7 52.230-7 PROPOSAL DISCLOSURE--COST ACCOUNTING PRACTICE

CHANGES (APR 2005)

K.8 INSURANCE - IMMUNITY FROM TORT LIABILITY

K.9 AUTHORIZED NEGOTIATORS

K.10 SIGNATURE

SECTION L –INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORs

L.1 NOTICE LISTING SOLICITATION PROVISIONS INCORPORATED BY REFERENCE 80

L.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

L.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

L.4 GENERAL INSTRUCTIONS TO THE OFFERORS

L.5 PROPOSAL SUBMISSION INSTRUCTIONS

L.6 INSTRUCTIONS FOR THE PREPARATION OF THE TECHNICAL

PROPOSAL

L.7 INSTRUCTIONS FOR THE PREPARATION OF THE COST/BUSINESS

PROPOSAL

L.8 EMPLOYMENT OF COOPERATING COUNTRY NATIONALS (CCNS) AND THIRD

COUNTRY NATIONALS (TCNS)

L.9 INSTRUCTIONS FOR THE PREPARATION OF BRANDING AND MARKING PLANS100

SECTION M: EVALUATION FACTORS FOR AWARD

M.1 GENERAL

M.2 EVALUATION OF THE TECHNICAL PROPOSAL

M.3 EVALUATION OF THE COST PROPOSAL

M.4 DETERMINATION OF THE COMPETITIVE RANGE

M.5 SOURCE SELECTION

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 PURPOSE

The purpose of this contract is to provide direct service delivery to support high quality, high volume, Voluntary Medical Male Circumcision (VMMC) and related services in rural and urban areas of South Africa, as described in detail in Section C, Statement of Work. The project will also support the transition of direct VMMC service delivery to the South Africa Government National Department of Health (NDOH).

B.2 CONTRACT TYPE

In accordance with FAR 16.102(b), this is a combination (hybrid) contract with two separate contract line items (CLINs): a requirements contract line item (CLIN 0001) and a cost-plus-fixed-fee, term form contract line item (CLIN 0002).

CLIN 0001: Pursuant to FAR 16.503, under this requirements contract line item, the Government will fulfill actual requirements for supplies and services during the contract period, with deliveries or performance to be scheduled by placing orders with the Contractor. The Contractor must provide the supplies and services specified in Section C at the fixed unit prices included in Section B.3.1 in the quantities required by Government-issued orders. Orders will be issued though modifications to the contract, in accordance with the ordering procedures in Sections F.9 and F.10 of this contract.

CLIN 0002: Pursuant to FAR 16.306(d) (2), under this cost-plus-fixed-fee (CPFF), term form contract line item, the Contractor must provide the Level of Effort specified in Section F.8 to accomplish the activities specified in Section C of this contract.

For the consideration set forth herein, the Contractor must provide the outputs as described in Section C and the deliverables as described in Section F, in accordance with the performance standards specified in Section F of this contract, and otherwise comply with all contract requirements.

B.3 CONTRACT PRICES/COSTS AND OBLIGATED AMOUNTS

B.3.1 CLIN 0001 - REQUIREMENTS CONTRACT LINE ITEM

a) Estimated Maximum Quantity:

The estimated total quantity anticipated under this CLIN 0001 is 685,000 units of comprehensive VMMC service packages. However, the Government is not obligated to nor limited to ordering this estimated total quantity of units. The amount of funds currently obligated for units ordered under this CLIN 0001 is $TBD”.

b) Fixed Unit Price:

Quantities and price schedules will be included in each order. The order prices will be based on the following fixed unit prices for the comprehensive package of VMMC services:

Each fixed unit price is inclusive of all associated operational costs, indirect costs and fees (if any).

B.3.2 CLIN 0002 - COST-PLUS-FIXED-FEE, TERM FORM CONTRACT LINE ITEM

a) Estimated Cost, Fixed Fee, and Obligated Amount:

(i) The estimated cost for the performance of the work required hereunder exclusive of fixed fee is: [$TBD]. The estimated fixed fee is [$TBD]. The total estimated cost plus fixed fee for CLIN 0002 is [$TBD].

(ii) Within the estimated cost plus fixed fee specified in paragraph (i) above, the amount currently obligated and available for reimbursement of allowable costs incurred by the Contractor (and payment of fee, if any) for performance hereunder is [$TBD]. The Contractor must not exceed the aforesaid obligated amount unless authorized by the Contracting Officer pursuant to the clause of this contract entitled "Limitation of Funds" (FAR 52.232.22).

(iii) Funds obligated hereunder are anticipated to be sufficient through [TBD].

b) Budget Line Items:

Category Total

Salaries and Wages Fringe Benefits Allowances Travel and Transportation Equipment Other Direct Costs (ODCs) Subcontracts (if any) Total Direct Costs Indirect Costs Fixed Fee (if any) TOTAL Estimated Cost Plus Fixed Fee

Fixed Unit Price

Fixed Unit Price

Fixed Unit Price

Fixed Unit Price

Fixed Unit Price

Comprehensive VMMC Package $TBD $TBD $TBD $TBD $TBD

Year 5 Category

Year 1 Year 2 Year 3 Year 4

c) Level of Effort (LOE):

Under CLIN 0002, the Contractor must provide 2,574 person days of professional technical LOE, including consultants and subcontractors’ LOE directly related to the technical aspects of the project, but excluding of any support personnel (such as administrative assistance, administrative clerical, drivers).

d) Indirect Costs/Rates:

The Contractor is allowed to recover applicable indirect costs, if it is part of the Contractor’s usual accounting procedures, consistent with FAR Part 31, and Negotiated Indirect Cost Rate Agreement (NICRA).

Pending establishment with the Government of revised provisional or final indirect cost rates, allowable indirect costs will be reimbursed on the basis of the following negotiated provisional or predetermined rates and appropriate bases for the Prime Contractor and their Major Subcontractors (“Major Subcontractors” are subcontractors whose proposed cost exceeds 20 percent of the Prime Contractor’s total proposed cost):

Description Rate Base Type Period

[TBD]

e) Cost Reimbursement:

The U.S. dollar costs allowable must be limited to reasonable, allocable and allowable costs determined in accordance with FAR 52.216-7, Allowable Cost and Payment, FAR 52.216-8, Fixed Fee, if applicable, and AIDAR 752.7003, Documentation for Payment. See FAR 52.232-22 Limitation of Funds for notification requirements for incrementally funded awards.

f) Payment of Fixed Fee:

Payment of fixed fee, subject to FAR 52.216-8, may be made upon receipt of a proper invoice. Subject to FAR 52.216-8, Fixed Fee will be allocated based upon the proportion of the labor provided over the period covered by the invoice. In the event that the contractor does not provide the total Level of Effort stipulated in the contract budget, the total amount of fixed fee will be reduced in similar proportion. For example, if the Contractor has expended 85% of the total level of effort, then the Contractor is entitled to 85% of the fixed fee amount, provided that the performance has been satisfactory. The total amount of Fixed Fee is payable upon receipt of the Contractor’s statement that the level of effort specified in the contract has been expended in performing the contract work.

[END OF SECTION B]

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

Voluntary Medical Male Circumcision (VMMC) Service Delivery

C.1 OBJECTIVE

USAID/Southern Africa’s key strategic objective is to assist the South African Government (SAG) to improve health outcomes for South Africans and to reduce HIV and TB infections through the targeted provision of voluntary medical male circumcision (VMMC) services. The Voluntary Medical Male Circumcision Service Delivery Project was developed in line with the National HIV/AIDS Strategic Plan for South Africa, 2012-2017. The new National Strategic Plan for the next five year period currently in development should maintain the same focus on VMMC for HIV prevention. The VMMC Service Delivery III project has the following objectives:

• To increase demand for high quality, high volume, cost-efficient VMMC services in South Africa among males ages 15-34 for specific sites in rural and urban areas identified in collaboration with USAID and SAG, through social mobilization1.

• To provide high quality, high volume, cost-efficient VMMC services in South Africa to males ages 15-342 through fixed, outreach and mobile VMMC sites in rural and urban districts identified in collaboration with USAID and SAG in order to reach 80% coverage of the target population to prevent new HIV infections in support of the South African Government.

• To coordinate the forecasting, procurement, quality assurance, distribution and storage of VMMC surgical kits and commodities.

• Support the transition of direct VMMC service delivery to the Department of Health facilities according to guidance provided by PEPFAR in South Africa.

C.2 OVERVIEW

C.2.1 Introduction:

The Voluntary Medical Male Circumcision Service Delivery Project (“the Project”) will be funded through the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). PEPFAR’s third phase, authorized in 2013, emphasizes sustainability and country ownership, expansion of prevention, care and treatment, and integration of HIV services within broader health systems and development programs.

1 Demand creation activities for males ages less than 15 (<15) and over 34 (>34) should not take place under this contract.

Demand creation activities for VMMC through mass media (i.e., television and radio spots) are already funded in South Africa by USAID. Collaboration with the implementing partner of this award to utilize collateral material produced through the award will be essential.

2 Males under 15 years may be circumcised if in compliance with SAG regulations, the client has proper informed consent forms, the young man understands the procedure, and will tolerate it when done under local anesthesia. Males over 34 years may also be circumcised through the project. However, no activities should take place to increase demand among individuals younger than 15 or older than 34 years.

PEPFAR’s overarching strategy for all technical areas including HIV prevention is described in the 2012 PEPFAR Blueprint: Creating an AIDS-Free Generation3. More specifics regarding PEPFAR’s approach to prevention are contained in the 2011 PEPFAR Guidance for the Prevention of Sexually Transmitted HIV Infections4. Both documents call for a “combination prevention” approach including biomedical, behavioral and structural interventions. Within a combination approach, PEPFAR prioritizes interventions with the strongest evidence of impact in reducing HIV transmission and acquisition. Voluntary Medical Male Circumcision (VMMC) is among those interventions that have shown high efficacy in randomized research trials. Results from three randomized, controlled trials (RCTs) published between 2005 and 2007 showed that VMMC reduced men’s risk of acquiring HIV infection from heterosexual intercourse by an average of 53% (South Africa5, Kenya6, and Uganda7).

The role of VMMC as a core intervention in curbing the HIV epidemic is underscored in PEFAR 3.0, Controlling the Epidemic: Delivering on the Promise of an AIDS-Free Generation8. While many challenges remain to scaling-up these potentially life-saving interventions for population-level impact, this document notes that scale-up for maximum impact on the epidemic, with substantial declines in HIV incidence, is the only way to reach a truly sustainable response and the final pathway to ending AIDS.

The Voluntary Medical Male Circumcision Service Delivery III Project will be directly in line with the National HIV/AIDS Strategic Plan (NSP) for South Africa, 2012-2017, which recognizes the importance of this intervention and includes high-volume, high quality VMMC service provision among its activities. Under this project, the contractor will support one of three development objectives of the 2013-2017 Country Development Cooperation Strategy of the United States Agency for International Development (USAID) in South Africa, which is to assist the South African Government (SAG) to improve health outcomes for South Africans.

C.2.2 Background:

South Africa has the largest number of people infected with HIV in the world: an estimated 6.8 million South Africans are living with HIV.9 An average of 1,300 South African adults become infected with HIV each day10, and nearly 400 South Africans die each day from AIDS-related illness11. As a result, there is an urgent need to scale up the HIV prevention response in South Africa, including the expansion of safe VMMC.

3 PEPFAR Blueprint: Creating an AIDS-Free Generation, 2012, http://www.pepfar.gov/documents/organization/201386.pdf 4 PEPFAR Guidance for the Prevention of Sexually Transmitted HIV Infections, 2011, http://www.pepfar.gov/documents/organization/171303.pdf 5 Auvert B, et al. Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk: the ANRS 1265 Trial. PLoS Med 2005 Nov; 2 (11): e298. Epub 25 October 2005.

6 Bailey R, et al. Male Circumcision for HIV Prevention in Young Men in Kisumu, Kenya: A Randomised Controlled Trial.

Lancet Infect Dis 2007; 369: 643-56.

7 Gray R, et al. Male Circumcision for HIV Prevention in Men in Rakai, Uganda: A Randomised Trial. Lancet Infect Dis 2007;

369: 657-66.

8 PEFAR 3.0, Controlling the Epidemic: Delivering on the Promise of an AIDS-Free Generation, 2014, file:///P:/Health%20Team/Male%20Circumcision/Awards%20&%20Contracts/Procurements%20in%20Progress/Fy16%20MMC %20Procurment/Background%20Documents/PEFPAR%203.0.pdf 9 UNAIDS,HIV and AIDS Estimate, South Africa 2014, http://www.unaids.org/en/regionscountries/countries/southafrica 10 L.C.Simbayi, South African National Prevalence, Incidence and Behavior Survey, Human Science Research Council. 2014 11 UNAIDS,HIV and AIDS Estimate, South Africa 2014, http://www.unaids.org/en/regionscountries/countries/southafrica

Results from three RCTs published in 2005-2007 showed that VMMC reduced men’s risk of acquiring HIV infection from heterosexual intercourse by an average of 53% (South Africa12, Kenya13, and Uganda14). VMMC also benefits women over time by decreasing the number of HIV-infected men in the population, thereby reducing the probability that women encounter HIV-infected sexual partners. VMMC also reduces the risk of acquiring several sexually transmitted infections (STIs), including human papilloma virus (HPV) infection, syphilis, chancroid, and herpes simplex virus-2, which is very common in South Africa.15

Although circumcision of HIV infected men has not been found to reduce HIV transmission to their female partners, the circumcision of HIV-negative men does have an impact on the epidemic among women. As HIV incidence decreases in men following VMMC scale-up, the probability of women encountering infected male sexual partners decreases, thereby reducing HIV incidence among women. Furthermore, modeling shows that if enough men are circumcised in South Africa alone, 310,000 new HIV infections (26%) could be averted by scaling up VMMC over 15 years, with a savings of $900 million in antiretroviral therapy (ART) costs.16

Recognizing the important potential of VMMC to dramatically reduce the number of new HIV infections in the country, South African President Jacob Zuma and the National Department of Health (NDOH) prioritized the scale-up of high volume, safe VMMC for HIV prevention. A national meeting was held in March 2010 to vet the VMMC implementation and clinical guidelines with provinces and to engage them in the planning process for national VMMC program scale-up. In May 2010, South Africa’s Deputy President Kgalema Motlanthe and Minister of Health Dr. Aaron Motsoaledi gave the green light to launch the roll-out of VMMC.

The NDOH set a goal of 4.3 million VMMCs over five years.

This target was estimated to provide 80% coverage of men aged 15-49 at the time of the target being set. The aim of this immediate “catch-up phase” was to rapidly achieve optimal coverage among adult men in an age group that is most likely to be sexually active and in which HIV incidence would be greatest. This type of strategy is recommended through UNAIDS’ Joint Strategic Action Framework to Accelerate the Scale-Up of Voluntary Medical Male Circumcision for HIV Prevention in Eastern and Southern Africa17.

12 Auvert B, et al. Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk: the ANRS 1265 Trial. PLoS Med 2005 Nov; 2 (11): e298. Epub 25 October 2005.

13 Bailey R, et al. Male Circumcision for HIV Prevention in Young Men in Kisumu, Kenya: A Randomised Controlled Trial.

Lancet Infect Dis 2007; 369: 643-56.

14 Gray R, et al. Male Circumcision for HIV Prevention in Men in Rakai, Uganda: A Randomised Trial. Lancet Infect Dis 2007;

369: 657-66.

15 Castellsagué X, Bosch FX, Muñoz N, Meijer CJLM, Shah KV, de Sanjosé S, Eluf-Neto J, Ngelangel CA, Chichareon S, Smith JS, Herrero R, Moreno V, Franceschi S, and the International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Male Circumcision, Penile Human Papillomavirus Infection, and Cervical Cancer in Female Partners. N Engl J Med 2002; 346: 1105-12.

16 Kripke K, Chen PA, Vazzano A, Thambinayagam A, Pillay Y, Loykissoonlal D, et al. 2015. Cost and impact of voluntary medical male circumcision in South Africa: Focusing the program on specific age groups and provinces; PLoS Med.

17 UNAIDS, 2011, Joint Strategic Action Framework to Accelerate the Scale-Up of Voluntary Medical Male Circumcision for HIV Prevention in Eastern and Southern Africa, http://www.unaids.org/sites/default/files/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2251_Action_Fram ework_circumcision_en.pdf

In November 2011, U.S. Secretary of State Hillary Clinton put forth a call to action to achieve an AIDS-free generation through a combination strategy that included expansion of VMMC with a goal of supporting over 4.7 million VMMCs in Eastern and Southern Africa through PEPFAR by the end of 2013. In line with this call, PEPFAR has continued to increase funding for VMMC and has prioritized 14 countries in sub-Saharan Africa for scale-up: Botswana, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Rwanda, South Africa, Swaziland, Uganda, the United Republic of Tanzania, Zambia and Zimbabwe.

PEPFAR, through USAID, the U.S. Centers for Disease Control and Prevention (CDC), the Department of Defense (DOD), the Global Fund to Fight AIDS, TB and Malaria, as well as the Bill and Melinda Gates Foundation, through the Clinton Health Access Initiative (CHAI), have made important contributions to the SAG VMMC program through investments in the scale-up of high volume VMMC sites and technical assistance. USAID/Southern Africa (SA) has been engaged in the roll out of VMMC since mid-2010, when the national program was launched.

USAID/SA works closely with the SAG to support demand creation for and the provision of high quality and safe VMMCs; shape relevant policy; vet VMMC implementation guidelines with the provinces; and engage provinces and districts in planning for VMMC scale-up.

USAID/SA has also supported a study to estimate the unit cost of the VMMC services in South Africa and the Decision Maker’s Program Planning Tool (DMPPT) 2.0. The DMPPT 2.0 tool generates data that (1) inform realistic budgets and targets for VMMC programs; (2) identify the current level of funding required to achieve program goals; and (3) model the costs and impacts of different service delivery models. Finally, together with the CDC, USAID is supporting the NDOH with the pilot roll-out of new World Health Organization (WHO) pre-approved non-surgical devices for VMMC.

Currently, USAID is supporting approximately 350 VMMC sites in Free State, Gauteng, KwaZulu Natal, Limpopo, Mpumalanga, and North West Province. Sites generally operate as one of three different modalities, as defined in the PEPFAR Best Practices for Voluntary Medical Male Circumcision Site Operations18: fixed, outreach or mobile. The selection of site modality is based on the existing clinic infrastructure, availability of staff, and access by the target population. Services are provided in public, private and non-governmental facilities. Sites in those provinces were identified due to low rates of VMMC and high HIV prevalence in the site catchment area. Currently, VMMC service delivery in these sites is being implemented with USAID/PEPFAR funding by the South African NGO Right to Care and a consortium of partners including the Center for HIV and AIDS Prevention Studies (CHAPS), and Maternal Adolescent and Child Health (MatCH), through a requirements contract.

Since the inception of the program, the CDC has also established a strong program throughout the country with approximately 200 sites in all nine provinces. PEPFAR partners from both agencies are expected to coordinate service delivery and demand creation efforts, especially in provinces where they operate in neighboring or the same district. Partners meet together multiple times a year, through several fora, to share challenges, lessons, provide technical assistance to

18 PEPFAR Best Practices for Voluntary Medical Male Circumcision Site Operations https://www.usaid.gov/sites/default/files/documents/1864/pepfar_best_practice_for_vmmc_site_operations.pdf the NDOH and coordinate implementation.

In order to achieve national scale-up of VMMC, both the SAG and PEPFAR/SA are supporting high-quality, cost-efficient services at high-volume VMMC sites by using the WHO’s Models for Optimizing Volume and Efficiency (MOVE) VMMC implementation approach. The MOVE approach consists of a set of models and options which can be implemented to increase operational efficiencies and outputs. MOVE combines human resource, supply chain, facility, technological, surgical and client flow innovations to ensure MMC operations bottlenecks are eliminated. The MOVE approach is essential for the catch-up phase of VMMC as it enables approximately 50 males per day to be circumcised by one small team of service providers, which would have circumcised only 8-10 males using prior methods.

The MOVE approach was developed at the Orange Farm VMMC RCT study site in South Africa, where high-volume VMMC services and training for MOVE providers are still being funded by USAID/SA. The MOVE model requires significant commodities to ensure swift and safe procedures and many high volume sites lack the space, staff bandwidth and/or autoclave capability to sterilize hundreds of instruments per day. To circumvent this issue, disposable, single-use kits are currently used by the majority of PEPFAR implementing partners and remain critical to the success of daily site operations. The VMMC disposable, single-use kits for the Right to Care consortium are currently primarily provided by USAID/PEPFAR, through its supply chain partner.

While the MOVE model has improved efficiencies at the site, the South African national VMMC program still faces several considerable challenges. For many communities in South Africa circumcision is usually part of a traditional rite of passage for adolescent males that does not occur in the clinic. Furthermore, the utilization of clinical service among males in South Africa is generally low. Creating acceptance for clinic-based VMMC has required investment in significant demand creation. Historically, USAID has supported other implementing partners to coordinate demand creation activities focused on increasing uptake of VMMC services. These activities include the production of mass media such as public service announcements for television and radio; billboards; print media in newspapers; the use of social media and mobile applications; and community-based social mobilization. Demand creation activities have, in turn, had an important impact on knowledge of MMC as an HIV prevention option as well as the uptake of services.

According to the Third South African National Communication Survey, 2012, 47% of men and women know that male circumcision reduces the risk of HIV infection, compared to just 8% in 200919. Based on client feedback at clinics, social mobilizers have also played a particularly important role in creating demand and in linking individuals to specific clinics in their community providing VMMC services. In addition, social mobilizers often organize transportation to clinics in coordination with service delivery implementing partners. Access to clinics and limited transportation, which is often cost prohibitive, especially in rural communities, is another barrier to services. While social mobilization has improved service uptake, coordination among multiple partners implementing social mobilization and VMMC

19 Third South African National Communication Survey, 2012, http://www.hivsharespace.net/en/resource/third-south-african-national-hiv-communication-survey-2012-key-findings service delivery has been logistically difficult to manage.

Unlike many countries in East Africa, the VMMC program in South Africa is doctor-driven, which is a challenge in a country with insufficient medical doctors for public health programs.

Recruitment and retention of medical doctors for the VMMC program among implementing partners has been challenging. Many partners have started integrating the program among private general practitioners in order to increase service delivery. This has been an effective partnership that has greatly increase performance in certain districts in South Africa.

Despite these challenges, the national VMMC program has made considerable progress in the past few years. As of December 2015, the number of VMMCs that have been performed to date total approximately 2.25 million, leaving the SAG with slightly more than 2 million VMMCs to perform by December 2016 to achieve the national target. Of the 2.25 million VMMC performed in the country, PEPFAR has contributed 1.3 million VMMCs (58% of the overall total performance).

As the national VMMC program has scaled-up there has been increasing emphasis on effective management of the quality and safety of services. In collaboration with the SAG, PEPFAR has conducted several external quality and data quality assessments on the VMMC program implemented by PEPFAR-funded partners. In 2014, through The Applying Science to Strengthen and Improve Systems (ASSIST) Project, implemented by the University Research Co. (URC), the continuous quality improvement (CQI) method was applied to the program.

This method was introduced to the PEPFAR VMMC program in South Africa, as well as in several other countries. The method empowers site-level quality improvement (QI) teams to identify gaps against WHO standards and test changes to address those gaps, as well as equipping QI teams with the skills to use their own data to improve the quality of care and scale-up best practices through shared learning. Initial findings have shown that CQI has improved the quality and demand of service delivery in several sites where it has been applied. CQI remains an important component of the PEPFAR-funded VMMC services to ensure quality and safety.

C.3 STATEMENT OF WORK

C.3.1 Key Results:

Under this project, the contractor will reach 80% coverage of the target population through:

• Increased demand for high quality, high volume, cost-efficient VMMC services in South Africa among males ages 15 to 34 for specific sites in rural and urban areas identified in collaboration with USAID and SAG, through social mobilization20.

• Provide high quality, high volume, cost-efficient VMMC services in South Africa to

20 Limited demand creation activities for VMMC through mass media (i.e. television and radio spots) are already funded in South Africa by USAID. Coordination with USAID and the implementing partner of this award to understand existing demand creation activities and utilize collateral material produced through the award will be required.

males ages 15 to 3421 through fixed, outreach and mobile VMMC sites in rural and urban districts identified in collaboration with USAID and SAG to prevent new HIV infections in support of the SAG.

• Coordinate the forecasting (including supplies buffer stock capability), procurement, quality assurance, distribution and storage of VMMC surgical kits, consumables and value-added commodities as well as related waste management and sanitation.

• Support the transition of direct VMMC service delivery to the Department of Health facilities according to guidance provided by PEPFAR and the NDOH in South Africa.

These key results will be achieved through the activities described below.

C.3.2 The Minimum Package of VMMC Services (CLIN 0001):

Under this contract, the contractor will deliver the minimum package of VMMC services per each circumcision as outlined by SAG, WHO, UNAIDS, and collaborating institutions in their clinical guidelines and toolkits for the provision of VMMC services. With this package the contractor will provide associated staff; quality assurance; services required for adverse events;

site operations; equipment; forecasting, procurement, quality assurance, distribution and storage of VMMC surgical kits and commodities; waste management; record keeping; social mobilization; demand creation; and overhead.

The contractor will ensure inclusion of both rural and urban; and fixed, outreach and mobile sites as determined through collaboration with SAG and USAID. Selection of all VMMC sites must be preapproved by USAID prior to launch. All new sites will be identified based on low VMMC prevalence and estimated high HIV incidence as well as population density and accessibility to men. SAG and USAID targets and geographic priorities will also be taken into strong consideration in site selection. Initially, there will be no overlap with sites VMMC sites currently being supported by USAID, although this contract may absorb those sites once USAID’s current mechanism ends, assuming demand continues to be high and both USAID and SAG agree that those sites should be sustained.

While the NDOH has noted that 15-49 is the target age group for the national program, PEPFAR funding will primarily focus on providing VMMC service to the age group of 15-34.

Mathematical modeling through the DMPPT 2.0 has shown that this age group will have the most immediate impact on the HIV epidemic in South Africa, and will be the most cost-effective in terms of infections averted.

The contractor will be USAID’s primary support to assist the NDOH in achieving the targets set forth in the NSP. There will be close collaboration with the NDOH VMMC team; provincial and district health teams; PEPFAR; and other partners (including, but not limited to, other USG agencies and non-USG donors) to assure tightly coordinated service delivery and demand

21 Males between 10 and 15 years may be circumcised if in compliance with SAG regulations, the client has proper informed consent forms, the young man understands the procedure, and will tolerate it being done under local anesthesia. Males over 34 years may also be circumcised through the project. However no activities should take place to increase demand among individuals younger than 15 or older than 34 years until USAID indicates otherwise.

creation, to avoid overlapping efforts or gaps in service coverage. This coordination will become increasingly important as the proportion of males circumcised in any given area increases.

Through full consultation with national, provincial, and district government, this activity will ensure full alignment with SAG priorities for VMMC.

The contractor will be accountable to USAID and NDOH to achieve coverage level results for circumcisions. Under this effort, circumcisions will avert infections as highlighted in the DMPPT 2.0 and based on PEPFAR’s VMMC district level VMMC prevalence estimates.

The contractor will implement services according to WHO, NDOH and PEPFAR guidelines and standards. In order to increase cost efficiencies, ensure quality service delivery and actively motivate achievement of coverage targets, the contractor is highly encouraged to use innovative mechanisms and to utilize local resources to accomplish the contract’s objectives.

The minimum package of services for both urban and rural provision of VMMC is comprehensive and in providing it, the contractor will:

• Perform VMMC successfully on males aged 15 to 34 years old22, as per the quality standards expressed in the WHO MOVE approach, PEPFAR VMMC guidance, and the SAG VMMC implementation and clinical guidelines;

• Coordinate the forecasting, procurement, quality assurance, distribution and storage of VMMC surgical kits, consumables and commodities23;

• Foster relationships with SAG and other partners to facilitate reaching objectives and avoid duplication;

• Ensure a strong management structure;

• Ensure appropriate staffing as well as staff training and supervision;

• Ensure access to and demand for VMMC services among men ages 15 to 34, including site specific social mobilization and collaboration with community and clinic-based partners that can help build demand;

• Liaise with USAID communication partners implementing limited mass media activities to generate demand for VMMC, as indicated by USAID, to ensure that social mobilization approaches and strategies are aligned and that collateral material is utilized;

• Provide universal pre- and post- VMMC counseling, including informed consent for VMMC, HIV prevention education and risk reduction, and appropriate wound care;

• Ensure that 100% of VMMC clients are offered voluntary HIV Counseling and Testing Services (HCT);

• Provide appropriate referrals for HIV-positive clients for care and treatment services and

22 Males between 10 and 15 years may be circumcised if in compliance with SAG regulations, the client has proper informed consent forms, the young man understands the procedure, and will tolerate it being done under local anesthesia. Males over 34 years may also be circumcised through the project. However no activities should take place to increase demand among individuals younger than 15 or older than 34 years until USAID indicates otherwise.

23 Note VMMC kits must be pre-approved by USAID.

use approaches to track these referrals to ensure their access to care;

• Ensure access to follow-up services two, seven and fourteen days after the provision of VMMC services;

• Successfully manage and accurately report all adverse events (AEs). Management of AEs will follow the WHO AE Guide. Rates of AEs should remain below the global WHO standard of no more than two percent of total VMMC performed and measures should be developed to respond to and reduce any pattern of cases of AEs;

• Manage health care waste produced by sites to ensure safe and appropriate disposal (for fixed, temporary and mobile sites);

• Liaise with USAID’s Global Health Supply Chain partner to ensure quality assurance of VMMC kits and other required equipment needed for VMMC sites;

• Provide robust monitoring and evaluation and quality assurance, including the application of continuous quality improvement methods and data quality assessment, for all aspects of VMMC service delivery to ensure continuous service improvement so that high quality services are maintained and targets are met;

• Utilize a system to monitor service delivery, demand creation activities and performance in real-time in order to plan VMMC services and demand creation more effectively and to meet reporting requirements;

• Liaise with external quality improvement or assessment partners or teams when indicated by USAID/PEPFAR;

• Incorporate innovative strategies to expand coverage and maximize the number of voluntary, high quality VMMCs that are performed through mobile and outreach services, seasonal surges, or other strategies;

• As appropriate, incorporate gender considerations into demand creation, service delivery, and counseling (e.g., engage mothers and partners, as and when appropriate); and

• Ensure that all VMMC services are in full accordance with quality, health and safety standards outlined by SAG, WHO, and PEPFAR in their clinical and operational guidelines for the provision of VMMC services.

Both urban and rural sites will be supported through fixed, outreach and mobile service delivery models. Determination of rural and urban sites and/or areas will be based on the 2011 South Africa Census.

As new VMMC technologies including WHO-approved devices or other methods are proven safe, effective, feasible and acceptable to implement in the South African context, the contractor will work with USAID and NDOH to determine if, when, and how to integrate these new technologies into contract implementation.

C.3.3 Targeted Technical Assistance (CLIN 0002):

In addition to the minimum package of VMMC services, USAID will request the contractor to provide technical assistance (TA) and in some instances equipment to support VMMC service delivery. This support will be associated with specific sites or districts as identified by USAID.

As district coverage levels are reached and at USAID’s direction, the contractor will provide TA to support the transitioning of direct VMMC service delivery to the Department of Health facilities according to guidance provided by PEPFAR/SA. In most cases, the contractor will work with the NDOH as well as provincial Departments of Health to develop a transition plan.

This will include, but not be limited to, an inventory of PEPFAR-funded human resources; a comprehensive training plan; an asset register and disposal plan; an assessment and summary of key stakeholders, and the scale-up of early infant male circumcision (EIMC). The contractor may also be required to support provincial and district leadership and provision of technical assistance to strengthen the management of the VMMC program or the scale-up of EIMC in close consultation with the NDOH, provincial Departments of Health and USAID. In some cases, it may be requested that demand creation services or the management of monitoring and evaluation activities continue for a limited period after the transition of direct service delivery for specific facilities.

In addition, USAID may direct the contractor to support health facilities through the provision of certain items in order to scale up service delivery and/or to transition services to the Department of Health. Support may include equipment, minor but necessary renovations to facilities, and vehicles/mobile units. Where possible, all efforts should be made to utilize existing infrastructure and to leverage Department of Health infrastructure.

C.4 GEOGRAPHIC LOCATION

VMMC service delivery will be provided in existing USAID-supported sites in Free State, Gauteng, KwaZulu-Natal, Limpopo, Mpumalanga, and North West provinces once the current VMMC contract ends in March 2017 and based on concurrence by USAID and SAG. New sites will be initiated in those provinces with potential expansion to other provinces as indicated by USAID and SAG. Both urban and rural sites will be included and fixed, outreach and mobiles models will be implemented based on SAG preference, efficiency, and feasibility. USAID and SAG approval will be required prior to launching new VMMC sites. There will be no overlap with other PEPFAR or Global Fund VMMC sites.

All sites must be pre-approved by USAID and SAG prior to initiation.

C.5 KEY PERSONNEL QUALIFICATIONS

The Contractor must furnish Key Personnel as stated below:

Position Name

- Chief of Party (COP) [TBD]

- Director of Financial Management and Operations [TBD]

- VMMC Senior Technical Advisor [TBD]

- Supply Chain Advisor [TBD]

- Demand Creation Advisor [TBD]

Key Personnel are listed in Section F. The minimum qualifications required for each key personnel position are as follows:

1. Chief of Party (COP). The COP will be responsible for overall technical leadership and management of the project and will serve as the principal institutional liaison to USAID. S/he must have:

• Master’s or postgraduate degree in management, international development, public health policy, or a related field;

• At least ten years of relevant experience in planning, managing, leadership and evidence-based decision making of similar HIV/AIDS service delivery programs;

• At least two years of experience managing VMMC programs in the Southern Africa region, preferably in South Africa;

• At least five years of relevant and diverse experience in managing and coordinating complex development programs in the Southern Africa region, preferably in South Africa;

• At least three years of successful experience interacting with the governments at national, provincial, and/or district levels in the Southern Africa region, preferably in South Africa;

and

• Strong interpersonal and communication skills, proven ability to develop and communicate a common vision among diverse partners, and proven ability to lead a multi-disciplinary team.

2. Director of Financial Management and Operations. This individual will be responsible for overall financial management and administration of the project. S/he must have:

• Master’s degree in financial management, Business Administration, Finance, Accounting or other relevant field, or a Bachelor’s or certified accounting degree with 10 years of experience;

• At least five years of relevant development financial working experience;

• At least seven years of experience in accounting, operations and financial management of large-scale, international development assistance programs;

• Familiarity with USG financial reporting and compliance requirements;

• Demonstrated experience and skills in developing and managing large budgets;

• Proficiency in relevant computer applications and databases; and

• Excellent written and oral communication skills.

3. VMMC Senior Technical Advisor. The VMMC Senior Technical Advisor will work under the direction of the Chief of Party to design, implement and manage all technical aspects of the program and to provide regular support and mentorship to all service delivery sites. S/he must have:

• Medical degree;

• At least three years of relevant experience working in VMMC in the Southern Africa region, preferably in South Africa;

• At least three years of successful experience working with government at national, provincial, and/or district levels in the Southern Africa region, preferably in South Africa;

• Strong leadership, communication and interpersonal skills, including proven ability to develop and communicate a common vision among diverse partners and lead a dynamic team;

• Demonstrated technical leadership in VMMC; and

• Excellent written and oral communication skills.

4. Supply Chain Advisor: This individual will lead demand planning and distribution of

Voluntary Medical Male Circumcision (VMMC) Kits, devices, and other health commodities and…