This PHE activity, "Comparison between volunteers providing HBC and peer group interventions in

improving adherence rates to ART", was approved for inclusion in the COP. The PHE tracking ID

associated with this activity is MZ.07.0076

This PHE was formerly: Prime Partner: US Centers for Disease Control and Prevention, Agency: HHS/CDC,

Funding Mech: Local

This is a continuing study from FY06: Activity ID # 5200. The title is "Comparison between volunteers

providing HBC and Peer Group Interventions in Improving Adherence Rates to ART". Year 1 (2006):

$60,000. Year 2 (2007): a modification of the 2006 contract is in process to provide an additional $45,000

for a total of $105,000 No FY08 monies are planned. The Local Co-investigator is The National Institute of

Health based in the Ministry of Health in collaboration with CDC and FHI (Family Health International).

• Project description: The main evaluation question is: which community level intervention is more effective

(including cost effective) in improving rates of adherence to ART in Mozambique, and is the improvement

significant. The community interventions in question are: volunteers providing Home Based Care within the

MOH guidelines and a peer group intervention. The design is a randomized controlled study and results will

inform policy development for the MOH in national adherence support strategies.

• Status of study/progress to date: The protocol has been developed and has passed the local ethics

committee and the ethics committee of FHI, and is currently awaiting CDC ethics review. It is planned to run

for 18 months after initiation. It is behind schedule due to delays in approval of a modification to the GAP6

Task Order as well as human resource constraints in all of the organizations involved. A national meeting is

planned to disseminate results at the end of the study.

New/Continuing Activity: Continuing Activity

Continuing Activity: 15697

Continued Associated Activity Information

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

System ID System ID

15697 15697.08 Department of To Be Determined 8865 8865.08 New PHEs

State / Office of

the U.S. Global

AIDS Coordinator

Table 3.3.08:

This PHE activity, "Evaluating barriers of access to pediatric HIV-care in a Mozambican rural setting (Multi-

country)", was approved for inclusion in the COP. The PHE tracking ID associated with this activity is

MZ.08.0093.

PARTNER: Track 1 ARV Moz Supplement/Elizabeth Glaser Pediatric AIDS Foundation

Study Title: "Evaluating barriers of Access to Pediatric HIV-care in a Mozambican rural setting"

This study will be done as part of a multi-country study, conducted in Tanzania and Mozambique, supported

by EGPAF.

Timeframe and budget summary:

Timeframe:

Month 1&2: Finalizing of study protocol, including instrument development; Submission of protocol for

approval by ethical committees; Planning of fieldwork and recruitment of interviewers

Month 3: Training of study team and data entry clerks. Training of interviewers and pre-testing of study

instruments

Month 4&5: Data collection

Month 6: Data entry and encoding of qualitative data

Month 7: Data Analysis & preliminary results

Month 7-8: Writing of report

Month 9: Dissemination of results

Budget Summary: Total budget requested: USD 155,000

Local co-investigators:

The study will be implemented in collaboration with the MOH and DPS in the respective provinces and

CDC.

The National Pediatric HIV ART scale-up coordinator appointed to DNAM will be co-investigator.

Project Description:

The availability and capacity to provide ART in Mozambique has increased over the past year. Considerable

resources are being invested to train providers to also treat HIV-positive children and to provide pediatric

ARV formulations. However, despite concerted efforts to improve access to ARV treatment for children less

than 5,000 (or 6%) of the roughly estimated 75,000 children in need of ARV are on treatment. EGPAF plans

to conduct an evaluation in each of the 4 provinces where it supports HIV care and treatment program to

identify key enabling factors and barriers within the community and the health system that impact children's

access to and utilization of HIV care and treatment services. This study will be part of a multi-country study;

EGPAF is implementing a similar study in Tanzania.

Evaluation Question:

"What are key enabling factors and barriers within the community and the health system that impact

children's access to and utilization of HIV care and treatment services" is the question under evaluation.

The primary objective is to identify barriers to HIV care and treatment services for HIV-exposed and HIV-

positive children. Therefore this evaluation will examine programmatic issues as well as beliefs, attitudes

and experiences of clients, health care providers and community members with regards to providing and

seeking access to care and treatment for children.

Programmatic importance:

Identifying reasons for poor access to and use of HIV care and treatment will lead to identifying policies and

specific interventions that will improve the identification, access to care and treatment and reduce loss to

follow up of HIV exposed and infected children and thus improve survival of HIV-infected infants and

children.

Methodology:

This evaluation is a cross-sectional multi-site survey, and will utilize quantitative and qualitative methods

including structured interviews, key informant interviews and focus group discussions as well as observation

of processes at the health facilities. The study will take place in the 4 provinces where EGPAF supports the

implementation of HIV care and treatment program: Maputo, Gaza, Nampula and Cabo Delgado.

Participants in the study will include health care providers, heads of health facilities where service are

provided, caregivers of HIV exposed and infected children, children on ART themselves, as well as

community members.

Structured interviews will be conducted with caregivers, children and community members.

Semi-structured interview guides and focus group discussion topic guides will be developed to further

explore process, attitudes, beliefs and experiences regarding:

- Individual client aspects/characteristics that enable or hinder follow up

- Community aspects/characteristics that enable or hinder follow up

- Health staff aspects/characteristics that enable or hinders follow up

The interviews and focus group discussions will be implemented by two interviewers trained in both

quantitative and qualitative methodology. The complete PHE protocol will be developed with technical

assistance from EGPAF research staff based in Washington DC. The protocol, the informed consent forms

and questionnaires and other documents used in this survey will be submitted to the Mozambican and CDC

Ethical Committee, to ensure that all ethical issues, particularly those pertaining to participation of children

in the study, are cleared. Children will be required to have a legal guardian to provide informed consent for

study participation.

Data will be double-entered into SPSS. In depth interviews and FGD will be tape recorded, transcribed and

coded for categories and themes. Data analysis will focus on the identification of barriers as well as

enabling factors to enrollment into and continued follow up to the HIV care and treatment program. Main

end points are: Number of children enrolled into HIV Care & Treatment programs in each of the 4 provinces

and the number and accessibility of routine HIV testing sites for HIV-exposed and HIV-infected children.

Secondary endpoints will include:

• knowledge and attitude of parents and caregivers towards enrollment of symptomatic children into

HIV/AIDS treatment programs

• Health care provider knowledge and attitude towards HIV testing of known HIV-exposed and HIV-

symptomatic children

• Level of health institution encouragement of uptake of antiretroviral therapy by eligible children determined

by structured interviews and assessment of processes

• Community knowledge and attitude towards risk for HIV/AIDS, and care and treatment among children

• Practices of how children currently on antiretroviral therapy enrolled into existing programs are supported

Activity Narrative: Population of Interest:

The study will be conducted over a total period of 9 months, where the study will be implemented in 2

districts per province (8 in total) and a minimum of 320 individuals will be interviewed. The populations to be

interviewed include potential clients or parents/caregivers of HIV exposed and positive children, community

members, and health care staff including nurses, clinical officers and physicians. In-dept interviews will be

conducted with health providers, traditional healers, community leaders, HIV+ mothers (who completed

PMTCT), members of the community and HIV+ children included in the Care & Treatment program. Two

persons of each population group will be interviewed per site. In each site, focus group discussions will be

held with community members, health care providers, HIV-positive mothers who entered in the PMTCT

program, and with children. Finally, in each site, one focus group discussion will be held per population

group.

For the study, a total of 320 individuals will be interviewed and an equal number will participate in FGD. To

identify study participants, first we will select randomly two sites in each province where HIV care and ARV

treatment is provided. Actual participants will then be randomly selected from pre-prepared sampling frames

by respondent group, including lists of members of health staff providing care and treatment services, staff

in pediatric departments, lists of pediatric patients on ART and in PMTCT program and community

members.

For each phase, the study team will contact selected respondents in the participating regions. A study

assistant will inform selected participants about the study and invite them to participate in interviews or FGD

anonymously. Interested parties will then be requested to provide informed consent prior to participation.

Information Dissemination Plan:

Results of this PHE will be presented in each of the provinces and within MOH to relevant ministry of health

officials. After this presentation, the results will also be presented to health staff in the supported districts as

well as community-based organizations that have been supporting HIV care and treatment services and

particularly have a role in the identification, referral and tracing of infants and children. Results will be

presented in a larger forum of MOH officials, the NGO community and national community-based

organization with the purpose to explore policies and strategies that may improve access to care and

treatment for HIV exposed and infected children. A paper will be prepared for potential publication and/or

presentation in international fora.

Budget Justification:

Budget item

1. Salaries/benefits of study team $ 53,860.00

2. Equipment $ 10,000.00

3. Supplies $ 8,000.00

4. Travel $ 39,040.00

5. Participants incentives $ 12,200.00

6. Other: Activities, training, supervision $ 31,900.00

TOTAL Project Costs $ 155,000.00

1. This budget items covers costs related to salaries and benefits for project staff including coordinator,

interviewers, a consultant statistician and data entry staff

2. Included are laptops for data entry during field work and tape recorders to be used during focus groups

discussion and individual interviews.

3. Office supplies include paper for duplication of data collection instruments and training materials, folders

and files and other office supplies needed during fieldwork and the course of the study

4. Travel includes any domestic travel and accommodation costs during training and fieldwork by the study

team. It also includes one trip by EGPAF HQ research staff to support planning and implementation of the

study as well as transportation vouchers for FGD participants.

5. This funding will also cover transport fees for focus group participants as well as overtime payment for

staff working on the study.

6. This category includes costs related to instrument development, training of the study team and

interviewers and dissemination of results.

New/Continuing Activity: Continuing Activity

Continuing Activity: 15718

Continued Associated Activity Information

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

System ID System ID

15718 15718.08 Department of To Be Determined 8865 8865.08 New PHEs

State / Office of

the U.S. Global

AIDS Coordinator

Table 3.3.09: