Why community involvement and participation?HIV vaccine research and development is about developing, testing and finding a successful HIV vaccine. It is also about developing people and their communities through meaningful community involvement and participation.

What is a community?We often talk about a community, as if it were one group of people who are all the same. But in fact, a community is more like a spider’s web. It is made up of many different people, who can look, feel and believe differently from each other, but are linked because they share something in common. For example, they may live in the same area or belong to the same organisation.

What is community involvement and participation?We can say that involvement is the beginning point of participation. It leads to participation. For example, involvement means drawing a person, a community or a group of people in to raise awareness about an issue, e.g., HIV vaccines. This includes getting ‘buy in’ and involvement in the issue from different individuals and subgroups through use of a ‘participatory approach’.

By becoming involved in the issue, people begin to participate in different ways (see over the page). This may lead not only to discovering a successful vaccine, but also to a stronger community with, e.g., more effective structures and organisations, and individuals with increased confidence, knowledge and skills.

What is the participatory approach?A project is more likely to fail if there is no community ‘buy in’ - people in the community do not feel that the project is theirs, they do not support it, or they feel that it is of no benefit to them. Sometimes this is because the project was introduced by ‘experts’ who had their own ideas about what should be done. This is called the top-down approach.

It is often better to use a participatory approach to ensure the project’s sustainability. This is when community involvement and participation are encouraged from the beginning and throughout the life of the project or the research. In this approach those running HIV vaccine research should:

Community involvement and partiCipation

• consult with as many people as they can in the community recognising and bringing the leaders, structures, committees, decision-making processes, resources, experience and knowledge that already exist into the research process. Consultation should begin early and be ongoing.

• involve the community in making decisions that affect them. They may help set up a group that represents the community, like a Community Advisory Group or CAG, to do this; and/or, they may work with organisations, committees and structures that already exist in the community.

• empower people by developing their knowledge and skills to take action on certain issues or needs. This tends to move communities higher up the ladder of participation (see ladder below).

• network with others in the community and outside it. This is to discuss specific issues or concerns or to get assistance.

Ladder of participationThere are many different levels at which communities can get involved and participate. These can be seen in the ladder below. Here the bottom steps show the least amount of involvement and participation while the top steps show more and more. In HIV vaccine research and development, communities are encouraged to get involved and participate in ways that are further up the ladder. A

co

mm

un

ity is

like

a s

pid

er’s

w

eb w

ith d

iffer

ent

gro

up

s o

r ‘th

read

s’ jo

ined

to

get

her

.

The

lad

der

of p

artic

ipat

ion

- a

dap

ted

fro

m ‘C

hild

ren

’s p

artic

ipat

ion

fr

om

to

ken

ism

to

citi

zen

ship

’ by

Ro

ger

Har

t, U

NIC

EF,

199

2.

Community involvement and participation cont.

How can communities be involved and participate?There are many ways that communities can become involved and participate in the HIV vaccine research and development process. These include forming or joining a CAG, becoming a trial participant or peer educator, or by helping with awareness events, etc. The CAG is a group of volunteers elected to represent the different interests and views of the community and is usually formed as part of Step 1 below.

What are the steps involved in participating in a clinical trial?The following steps occur in most HIV vaccine clinical trials. However, trials may differ in the exact way that each step is done.Step 1: Consultation with stakeholders, choosing the trial site and establishing a CAG.Step 2: Trial site staff recruit and pre-screen potential trial participants.Step 3: Researchers screen volunteers again to see if they meet the trial criteria. If, for example, a trial requires healthy individuals, over the age of 18, a person can join the trial if they meet these trial criteria. Step 4: Enrolment (part 1): Informed consent and allocation to a trial group.Step 5: Enrolment (part 2): Administration of the first dose of the vaccine or placebo.Step 6: Monitoring for immediate adverse events.Step 7: Follow-up visits and doses.Step 8: Researchers analyse the data.

Step 9: Feedback and unblinding interviews. Unblinding is a process during which trial participants are told whether they received the HIV vaccine or the placebo.Step 10: Long-term follow up of participants who, e.g., become pregnant, or HIV-positive, during a preventative HIV vaccine trial. Step 11: Decisions about whether to take the potential HIV vaccine to the next phase of the clinical trials.

Ongoing community involvement and participation Researchers and community educators should use a participatory approach to encourage communities to be actively involved and participate in all parts of the HIV vaccine research and development process.

This includes consultation with various community stakeholders when identifying a particular trial site. Community stakeholders may include different levels of government (national, provincial and particularly local government) and other relevant leaders and community structures. There should also be ongoing consultation and dialogue with the wider community throughout the research. Usually the trial site will also help set up the CAG.

What are the main roles of the CAG?• The CAG’s main responsibility is to represent the

community. They should engage with researchers as an equal partner and should contribute in a meaningful way to decision making about research issues that affect the community.

• The CAG is a communication link between the community and the trial site staff. It gives information, answers questions and educates the community about HIV vaccine research and development.

• The CAG advises researchers on community issues, for example, how to best give information and what recruitment methods are culturally sensitive.

• It encourages community involvement and participation in research processes.

• It can make sure that any human rights and ethical issues, and personal concerns from the community and or the trial participants are addressed.

• For more information, please see the SAAVI CAG Guidelines at www.saavi.org.za.

Co

mm

un

ity m

emb

ers

can

att

end

mee

ting

s o

n H

IV

vacc

ines

This Fact Sheet was produced by Masikhulisane, the South African AIDS Vaccine Initiative’s (SAAVI) Community Involvement Programme. SAAVI is currently funded by the National Department of Health (NDOH), and the Italian Cooperation with the technical and scientific collaboration and support of the Italian National Health Institute (ISS). ©June 2010

Department of Health