PARTNER: Ethiopian Public Health Association

Title of Study:

Identifying the barriers to couples' utilization of VCT services

Time and Money Summary:

Expected timeframe of study from protocol development to completion: 6 months

Total projected budget: $150,000

Local Co-Investigator:

The study will be contracted out on competitive basis to an Ethiopian public health research team with

necessary areas of expertise. The selection criteria will be based on the quality of technical proposal and

reasonable cost, as assessed by group of experts from the Ethiopia Public Health Association (EPHA) and

USG. The research team will undertake activities from the level of protocol development to analysis and

reporting final study output.

Project Description:

PEPFAR assistance in FY2004-2006 to expansion and strengthening of HIV counseling and testing (HCT)

services in Ethiopia has greatly increased access for HIV counseling and testing, from 600 sites with

COP06 funding to 800 sites--including hospitals and health centers—with COP07 funds.

Assessments undertaken by PEPFAR partners have identified major issues that constrain and influence

utilization and quality of voluntary counseling and testing (VCT) services. Among these are low performance

level and high turnover of counselors; substandard level of record keeping, timely reporting and utilization of

data at VCT sites; and problems in supply chain management.

Review of data from the National VCT Model centers showed that turnout of couples as clients is as low as

15% for those tested at the same time. A recent study also showed disclosure of HIV test results to spouses

or partners is low. Little is known as to why VCT service utilization by couples is so low. Therefore,

identifying factors associated with low utilization of VCT is critical in the development of strategies in

intervention activities to increase demand for VCT services.

Evaluation Question:

A number of factors affect demand for couples' VCT. Some hypotheses are that low couples' demand is

due to lack of knowledge about where VCT can be found, fear of stigma, and gender inequity between

husband and wife, which does not support joint decision-making. The primary study question is "what are

the primary factors that serve as a barrier to couples' utilization of services?" The study will additionally

identify potential strategies for overcoming these barriers.

Programmatic Importance:

Given the low demand for VCT among couples, program coordinators, policymakers and other influential

groups have not promoted couples' VCT, thus missing the potentially important target groups of HIV-

positive couples and discordant couples. The proposed study will identify the primary barriers to couples'

utilization of VCT services and will provide potential strategies to overcome these barriers. Dissemination of

these study findings will enable program planners and managers to incorporate new strategies to increase

couples' testing, thus reaching currently under-served target populations.

Methods:

A cross-sectional study design will be employed to identify factors for low utilization of VCT service among

married couples in Ethiopia and their magnitude. Multi-stage cluster sampling will be used to select

accessible districts with VCT service and sample communities (wards) will be drawn from categories of

districts in Ethiopia with VCT services facility based on levels of VCT service utilization.

Study subjects will be selected randomly among married couples in each selected ward. The sample size

for the study will be determined based on a standard formula for a single population study, with due

consideration to the study design and non-respondents.

A structured interview questionnaire will be used to collect data from sampled couples of selected districts.

Additionally, focus group discussion will be conducted among different community groups, service

providers, program managers, decision-makers, religious leaders, and community leaders. The collected

data will be entered into computer and cleaned. Analysis of data will be undertaken using software for

qualitative and quantitative data. Quantitative data will be tested using appropriate statistics and

disaggregated by district and other socio-demographic characteristics.

The researcher team will be provided with supportive supervision from EPHA and USG Ethiopia throughout

the study period.

Population of Interest:

The primary population of interest is married couples, including PLWH and discordant couples.

Information Dissemination Plan:

There will be dissemination workshop on the findings and all EPHA members and other relevant

stakeholders will be provided with publication of the study output.

Budget Justification for Year One Budget:

Salaries/fringe benefits - $50,000

Equipment - $0

Supplies - $10,000

Travel - $43,605

Participant Incentives - $0

Activity Narrative: Laboratory testing - $0

Review Protocol - $2,300

Publication of document - $6,000

Dissemination workshop - $17,000

Dissemination of document - $700

Sub-Total - $129,605

EPHA 15% indirect costs - $20,395

Grand Total - $150,000

New/Continuing Activity: Continuing Activity

Continuing Activity: 18798

Continued Associated Activity Information

Activity Activity ID USG Agency Prime Partner Mechanism Mechanism ID Mechanism Planned Funds

System ID System ID

18798 18798.08 Department of To Be Determined 8863 8863.08 New PHEs

State / Office of

the U.S. Global

AIDS Coordinator

Table 3.3.14:

PHE added 1/23/09

PHE Tracking Number: ET.07.0209

PHE Title: Effects of PEPFAR Supported Interventions on the Health Sector

New/Continuing Activity: New Activity

Continuing Activity:

Program Budget Code: 15 - HTXD ARV Drugs

Total Planned Funding for Program Budget Code: $25,132,215

Total Planned Funding for Program Budget Code: $0

Program Area Narrative:

Ethiopia's size and difficult terrain require a substantial logistics investment. Furthermore, Ethiopia's 2006 decision to decentralize

antiretroviral treatment (ART) services to the primary healthcare unit has demanded intensive support from all stakeholders to

reach the national targets. The Ministry of Health (MOH) has undertaken a strong effort to achieve universal access to both

primary health care and HIV services. These efforts, while rapidly increasing the number of individuals on ART, have produced

major stresses, particularly in supply chain and human resource systems. These stresses, if not alleviated, may ultimately

threaten the stability of the entire health care system. Two national HIV commodity quantification exercises in 2007 revealed

massive gaps in most commodities needed for HIV programs. While funding for ARV and sexually transmitted infection (STI)

drugs, as well as rapid test kits (RTKs) is relatively secure, there are major gaps in financing for most other commodities, including

opportunistic infection (OI) drugs, infection prevention (IP) materials and ready-to-use therapeutic food (RUTF)

PEPFAR's supply chain management funding supports all portions of the PEPFAR portfolio, ensuring an effective distribution

system to provide condoms for prevention programs, drugs for ARV, prevention of mother-to-child transmission (PMTCT), OI and

STI programs, IP materials for all HIV and health care programs, RTKs, other lab reagents and supplies for voluntary counseling

and testing (VCT), ART, OI, PMTCT and STI programs, as well as home-based care (HBC) kits and RUTF for facility and

community-based activities.

The logistics operations support all aspects of PEPFAR's urban and periurban focused program, as well as rural "hot spots",

allowing the focus on high impact/high yield areas to be maximally effective. PEPFAR focuses on sustainability through capacity

building and implementation of the national logistics master plan, while supporting private pharmacies to increase ART coverage.

Coordination with other donors is emphasized, with links to the Clinton HIV/AIDS Initiative (CHAI) and the Global Fund To Fight

AIDS, Tuberculosis and Malaria (GFATM) particularly important.

Distribution of free ARV drugs began in January 2005 with PEPFAR and GFATM support. According to the MOH's HIV/AIDS

Prevention and Control Office (MOH/HAPCO) June 2008 report, adult and/or pediatric ARV drugs are currently provided at 346

sites, up from 265 in May 2007. The decentralization has resulted in over 22% of patients currently being served at health

centers, up from 11% in May 2007 and zero in June 2006.

From FY2004 to FY2006, Management Sciences for Health/Rational Pharmaceutical Management Plus (MSH/RPM+) effectively

supported procurement of ARVs for Ethiopia's program. MSH/RPM+ also supported coordination of warehousing, in-country

distribution and stock status monitoring by PHARMID, the country's parastatal central medical stores, since returned to the public

sector and renamed the Pharmaceutical Fund and Supply Agency (PFSA). The project's Regional Pharmacy Associates, based

in regions supporting PFSA implementation efforts, now focus at site level. RPM+ also assisted MOH/HAPCO in the distribution

of first line adult ARV drugs supplied through the GFATM, and provided emergency supplies when MOH procurement was

delayed. Since PEPFAR support began in 2006, there has been only one ARV stock out (of one product for one day), a

remarkable achievement in logistics. During FY2007, this procurement support, as well as national and regional support for

supply chain management, was transitioned to the Partnership for Supply Chain Management (PFSCM), through the Supply

Chain Management System (SCMS). Under COP09 it is envisioned that the MSH/RPM+ site level logistics support will be

assumed by SCMS.

In COP 06 and COP07, PEPFAR Ethiopia supported procurement of second line adult ARV drugs, all pediatric formulations and

also reserved funds for emergency purchases of adult first line drugs. MOH/HAPCO supplied adult first line drugs, using GFATM

funds. Under COP08, the CHAI assumed responsibility for procuring the pediatric and adult second line ARVs formerly supplied

by PEPFAR, with SCMS handling customs clearance, supply chain management and distribution support costs in coordination

with PFSA. Since CHAI support for second line ARVs ends as of December 31, 2009, discussions with the MOH on how the

support will be maintained will occur in coming months.

This shift in ARV funding responsibilities allowed PEPFAR, under COP08, to cover a portion of the very substantial HIV

commodity gap in some critical program areas, such as OI drugs, RUTF, HBC kits, PMTCT supplies and equipment, and IP

materials, in collaboration with the MOH and other stakeholders. SCMS supported the first National HIV Commodity

Quantification Exercise in March 2007, updated in October 2007. This quantification/costing of all major HIV commodities showed

a total need for $477 million in commodities for calendar year 2009, with only $160 million committed to cover the needs for

universal access to HIV services, per the targets of the MOH's Road Map 2007-2008: Accelerated Access to HIV/AIDS

Prevention, Care and Treatment in Ethiopia. This $317 million gap highlights the need to prioritize key commodities and

quantities to be procured. Under COP09, PEPFAR will continue to support and provide technical support for this process through

SCMS, with MOH leadership.

SCMS was funded with a total of $122 million under COP06, COP07 and COP08. As of September 30, 2008, $56 million of this

had been expended, leaving a pipeline of $66 million. Spending projections estimate that the entire remaining pipeline will be

expended by December 31, 2009.

Of the total funding, over $60 million has been committed through SCMS to cover a portion of the large commodity gap in 2009:

$19 million for OI drugs, $16 million for IP materials, $10.5 million for lab reagents and supplies, $6 million for RUTF, $4.8 million

for PMTCT supplies and equipment, and $4 million for HBC kits.

SCMS will utilize approximately $6 million of the proposed $26.5 million of COP09 funds for operations and technical assistance,

with TA going to support systems strengthening as the ambitious national Pharmaceutical Logistics Master Plan (PLMP) rolls out.

Already under COP08, PEPFAR has, through SCMS, procured the vehicles needed by national and regional warehouses, to

distribute commodities to site level. COP09 efforts will focus on development and deployment of the logistics management

information system (LMIS), as well as training staff in the new system. SCMS also covers distribution costs for all ARVs in the

country, as well as other GFATM and CHAI-procured products, with $7 million dedicated for this purpose. Under COP09,

PEPFAR contributions to commodity procurement will be substantially reduced from COP08 levels, with approximately $13 million

dedicated for procurement, seeking to maintain PEPFAR's commitment to provide emergency buffer ARV stock, as well as some

RUTF (which no other donor is funding in a significant way).

The ARV buffer is a USG commitment under the USG-Government of Ethiopia (GOE) Memorandum of Understanding which

defines commitments in a number of commodity areas. Around $4.5 million of emergency ARV support was provided to the MOH

in 2008. While the buffer is maintained for most of the year, it is hoped that a substantial portion of this $12 million fund will be

available for gap-filling purchases in other commodity areas such as OI drugs and infection prevention materials, although not to

the level achieved in 2008, when the large pipeline allowed greater support. USG assistance in developing GFATM or other

funding proposals to fill some of these gaps will be critical, since adequate funding is not available at this time.

SCMS also began seconding staff to support supply chain management, placing one individual at the Ethiopian Health and

Nutrition Research Institute (EHNRI), the national reference laboratory, one at HAPCO, and several at PFSA. As of March, 2008,

at least 300 individuals were seconded to national, regional and facility levels by PEPFAR partners, supporting quality information

systems, with a major focus on logistics and pharmaceutical management. Around 275 of these were data clerks at facility levels,

compiling pharmacy, logistics and other health information.

During COP09, under the direction of PFSA, PEPFAR Ethiopia will support the provision of ARV to 131 hospitals and 300 health

centers, reaching over 200,000 patients by September 30, 2010. Other HIV commodities will be provided to virtually every

existing hospital and health center in the country, supporting a total of approximately 800 sites. The tiered approach utilized by

PEPFAR will support prevention and home-based care services at those sites where HIV prevalence is low, thus allowing a

gradual extension of services to more rural areas, while maintaining the focus on periurban and urban areas with higher

prevalence and patient load.

SCMS will continue to provide technical and secretariat support for a coordinating body, the HIV Commodity Supply Management

Committee, which will lead the national quantification exercises. In conjunction with MOH/HAPCO, PFSA and EHNRI, SCMS will

prioritize commodity gaps and procure commodities with available funds to fill the most pressing needs. SCMS will continue an

activity begun in late 2006, procuring commodities for MOH/HAPCO/EHNRI using GFATM monies, leveraging its considerable

unit price advantage and Regional Distribution Centers (RDCs) to enhance Ethiopia's HIV programs, providing lower-cost, high

quality products in a timely fashion.

The centrally-funded MHS/RPM Plus project is ending, to be replaced by Strengthening Pharmaceutical Systems (SPS), also

under MSH. Its activities with the MOH Pharmaceutical Supplies and Logistics Department (PSLD) are in limbo, as PSLD's status

under the current MOH reorganization effort is unclear. Depending on final decisions as to PSLD's functions, SPS may assist in

drug utilization management, including monitoring and evaluation. SPS will continue activities with the Drug Administration and

Control Authority (DACA), Ethiopia equivalent of the U.S. Food and Drug Administration, and Regional Health Bureaus (RHBs),

supporting and promoting Rational Drug Use (RDU), drug efficacy and toxicity monitoring, Adverse Drug Reaction (ADR)

monitoring/reporting, Post-marketing Drug Surveillance (PMS), ARV adherence support, antimicrobial resistance (AMR) activities,

establishment or strengthening of Drug Information Centers (DIC) and Drug Therapeutic Committees (DTC), as well as private

sector activities. Pharmacy data clerks supported by SPS are expected to be funded by the MOH/RHBs under COP09, as

funding for these positions was included in the GFATM Rolling Continuation Channel (RCC) proposal, at PEPFAR's request.

Under PFSA and DACA's direction, SPS will also support GOE agencies in pharmaceutical training, patient education; and

promotion of collaboration between programs and stakeholders. SCMS will assume essentially all supply chain management

functions, with SPS focusing on pharmaceutical management.

A new activity, the United States Pharmacopeia (USP), will assume former RPM Plus/SPS drug quality assurance activities,

working closely with DACA to strengthen its Quality Control Laboratory and establish regional quality control mini-labs. This

activity will collaborate closely with the Presidential Malaria Initiative (PMI), leveraging $200,000 of PMI and core funds for drug

quality improvement.

Under PFSA's direction, PSCMS will coordinate PEPFAR/GFATM joint procurements, and will work to support effective in-country

distribution, providing TA to incorporate state of the art logistics practices and technologies. COP08 support in provision of

vehicles has filled currently identified needs to ensure a fully functional distribution system. Rental of warehouse space to provide

temporary space for the large quantities of commodities required for planned expansion of services will be continued, until MOH

efforts to build or expand warehouses are finalized. While PEPFAR will support the PLMP to the greatest extent possible, it will

not be possible to support all areas, for example the revolving drug fund, which may be supported through TA, but not

capitalization.

SCMS will also support PFSA in the development of an effective logistics management information system (LMIS), in

collaboration with other USG partners including USAID/DELIVER (funded with USAID Population funds) and SPS, as well as

CHAI and UNICEF. SCMS will continue to provide TA to the Ethiopian Health and Nutrition Research Institute (EHNRI) to

implement a comprehensive logistics management system for laboratory commodities, which will eventually be integrated in the

PLMP. Challenges in distribution of commodities to site level will be addressed through temporary measures, including use of

SPS vehicles and close collaboration with PEPFAR partners supporting service delivery at hospitals and health centers.

In COP09, PEPFAR Ethiopia and GFATM will further strengthen their relationship by working more interdependently to support

national scale-up efforts. PEPFAR's support to PFSA and DACA will be a central part of technical assistance efforts, including

substantial support to ensure that supportive supervision of the supply chain is consistently provided. The Memorandum of

Understanding signed between the Governments of the U.S. and Ethiopia to define GFATM/MOH and PEPFAR responsibilities

may be amended, since responsibilities for procurement of some commodity types are not delineated. While GFATM will continue

to supply adult first line drugs, CHAI will purchase adult second line adult drugs only through December 2009, and will no longer

procure pediatric ARV drugs as of December 2010; PEPFAR must work with the MOH to address these changes and buffer funds

may be used for this purpose in the later part of 2010. Due to persistent shortages of other essential commodities such as OI

drugs, lab reagents (especially rapid test kits), RUTF and IP materials, PEPFAR Ethiopia will provide gap-filling supplies to the

extent resources can cover these, to support fully functional HIV/AIDS services.

Table 3.3.15: