Community involvement and participation

Development of these overheads was made possible through funding from the European Commission (EC), and through the South African AIDS Vaccine Initiative (SAAVI), a lead programme of the South African Medical Research Council (MRC).

What is a community?• A group of people who share something in common• Members can:

– have different positions based on e.g. age, class, gender etc.– belong to subgroups e.g. be one of the supporters

in the soccer community.– play different roles e.g. leader, follower etc.

• Like a spider’s web:– made of many threads of different

people/groups joined together.

What is involvement & participation?

• Involvement means drawing someone in

• The beginning of participation– taking part in something

• Different ways to participate

• Involvement & participation must be ongoing

What is community involvement & participation?

• Drawing communities & individuals into– e.g. the HIV vaccine research & development process

• Once they are involved, they can participate

• By being part of decisions & activities that affect them

• Contributes to better research

• Helps to build & develop communities

Why community involvement & participation is important

• A project is likely to fail if the community:– do not feel the project is theirs,

– do not support it, or

– feel it does not benefit them

– use of a ‘top-down approach’

• A participatory approach is better

Participatory approach

• Encourages CI & participation from the start & throughout

• Those running the project should:– consult as many community members as possible.

– involve community members in making decisions that affectthe community.

– empower the community by developing their knowledge & skills

• Community members network in & outside the community– to discuss issues/ concerns or to get assistance.

Ladder of participation

• Different levels of community participation

• Bottom steps of ladder show the least

• Top steps show more and more

• In HIV vaccine R & D we aimfor the top steps

Why researchers should ensure CI & participation.

• So community know about & understand the research - puts themin a better position to support it.

• So trials are ethical:– the community is involved & participates in decision-making about

issues that affect them.

• So legal & human rights of trial participants & their communities are:– respected, protected, promoted & fulfilled.

How researchers ensure CI & participation

• Being honest & transparent.

• Giving as much information as possible, e.g. info on:– What HIV vaccines are, how they work, different designs, stages &

phases in development, benefits & risks involved

– Ethical, legal & human rights issues

– Research standards e.g. GCP

– Practical information e.g. steps in a trial

• Using the participatory approach.

Why communities should be involved & participate

• To benefit from the research.

• To empower the community & the people in it.

• To give back to their community.

• To have a say in decisions that affect them.

• If we participate in something that affects us, there is a bigger chance that we will be:– committed to it, and

– able to influence it.

CI & participation to developing countries & communities

• Faster access to a successful HIV vaccine

• Finding a vaccine the works against the most common subtype

• Countries build their facilities & the abilities of their researchers

• Communities help find a solution to HIV and AIDS

• Community & people development

Benefits of

Risks to becoming involved & participating

• Possible harm, e.g., risks of the research

• Possible exploitation– e.g. if communities take part in the research but do not have access

to a successful HIV vaccine - UNAIDS says this is unethical.

• Community conflict & stigmatisation– e.g. if they do not want the trial there

– e.g. discrimination against community/ trial participants

• Reduce risks by following, e.g. ethical guidelines & GCP

Steps in a clinical trial

Step 1:Consultation, choosing the trial site & establishing a CAG

Step 2: Trial site staff recruit & pre-screenpotential trial participants

Step 3:Researchers screen volunteers again for eligibility

Step 4:Enrolment (part 1): Informed consent and allocation to a trial group

Step 5:Enrolment (part 2) and getting the first dose of the vaccine or placebo

Step 6:Monitoring for immediate adverse events

Steps in a clinical trial

Step 7:Follow-up visits and doses

Step 8:Data is analysed by researchers

Step 9:Feedback and unblindinginterviews

Step 10:Long-term follow up of participants with breakthrough infections and/or pregnancy

Step 11:Decisions about whether to take the vaccine to the next phase

Community entry process

• See Consultation overheads

• The community is complex

• Need to visit it more than once. Through repeated visits:– Community expose more about themselves

– You get to know, understand & build relationships with the community

• Need ongoing consultation & dialogue during research

• See Penina’s cup

Penina’s cup

• Represents different layers in a community.

• Must consult each one.• Start at the top to get to the

3rd layer.

Top Layer of the communityIce that is light & hardThey often say they speak for the community, & can stop you from reaching the community.

2nd layerCold, icy water that’s semi-hardRepresent the more advantaged community members. Some are natural leaders who know the community better than the top layer.

3rd layerWarmer than the restThe silent majority. Usually the last to be seen & consulted.

Step 1: Consultation

• Researchers need to consult & get agreement from community stakeholders when choosing a trial site:– different levels of government (national, local etc.),

– other community leaders & community structures

• If successful, a new level of community involvement begins

• Inform wider community about research

• Encourages community to get involved& to participate from early on

First level of consultation

Consultation with the wider community

• Through workshops & meetings

• Background research into the community– e.g. leaders, culture, subgroups etc.

• Work with existing community structures& organisations e.g. NGOs, CBOs, ASOs

• Understand how they fit into local, provincial & national structures, e.g. District Health System

Hospital Boards, Clinics & Community Health Centre

Committees

Provincial Health Council

National Consultative Health Forum

National Health Council

District Health Council

Step 1: Consultation

How Government encourages community involvement

• Through the SA Constitution & other laws

• Example of the National Health Act, 2003– Section 42 [1] (a,b,c) – committee for a clinic/s or community health

centre/s

– Section 42 [2] (a,b) – the committee must include one or more local councillors and one or more members from the community that the health facility serves

• Through governance structures such as the District Health System

What is a community advisory group (CAG)?

• A formal structure or group that represents the interests of thecommunity & engages with the researchers

How is a CAG formed & how does it operate?

• Usually trial site helps to establish it.

• They can invite the following people to join:– community leaders, public health officials & interested individuals

– representatives from community organisations & structures

• Or an open invitation – allows ordinary community members to join

• Can encourage representatives from marginalised group to join

• The community also has a responsibility to establish a formal group like the CAG

How does a CAG work?

• Each CAG may work slightly differently

• May look at more >1 health research area

• Example of a process:– Trial site help set up CAG

– CAG develop Mission, Vision & Constitution

– Appoint people to positions, e.g. chairperson

– Trial site & CAG discuss how to work together

– Regular meetings & activities, + records, e.g. minutes

Main responsibilities of a CAG?

• Represent community interests

• Should engage with researchers as an equal partner

• Meaningful contribution to decisions about the research& the trials that affect the community

CAG responsibilities to community & trial participants

• Represent community interests

• Make sure human rights, ethical & community concerns are addressed

• Give information & answers questions

• Encourage community to get involved & to participate

• Help solve conflict between groups, e.g. researchers & community

• Participate in research decisions that affect the community

• Help create a supportive environment

CAG responsibilities to trial site staff

• Communication link between the community & trial site staff

• Advise researchers on matters about the community, e.g.:– the best way to give information to the community

– recruitment methods that could work better

– informed consent methods that could work better

CAG responsibilities to others

• Form networks & partnerships with other community organisations

• Consult with formal community structures, other stakeholders, & government programmes

• This leads to co-ordinated activities & avoids duplication

• Discuss issues with other groups/advisorson behalf of the community

Ways to participate

CAG & or

Go to meetings & workshops on

HIV vaccines.

Volunteerfor trials.

Help raise awareness.

Help the CAG/ other community groups.

Report on/keep up to date on HIV vaccines.

Join/form a group to debate related issues.

Apply to be an HIV vaccine educator/

peer educator.

Trial site staff recruit & pre-screen potential participants• Community outreach staff recruit volunteers

• Radio, newspaper, TV, posters, & meetings etc.

• To volunteer, you can ask or call HIV vaccine trial site staff, or call– the SAAVI Info-Line: 080 8222 463

• Pre-screen volunteers by asking about:– e.g. age, HIV status - according to trial criteria.

• Other ways to participate too

Step 2

Researchers screen volunteers for eligibility

• More screening, stricter criteria

• In preventative HIV vaccine trials:– e.g. HIV test, pregnancy test, but need informed consent

– May be questions about sexual behaviour to assess HIV risk level• e.g. phase I needs people at low risk of HIV infection, phase III needs

people at high risk of HIV infection

• Complete medical check up

Step 3

Enrolment (part 1): Informed consent & allocation to a trial group

• Volunteers go through informed consent (IC)

• If they decide to participate:– they sign & date the consent form.

– so does the person who did the IC

• Randomly allocated to either:– the intervention group (get vaccine), or

– the control group (get placebo)

• Double-blind study

• Informed consent is ongoing

Step 4

Informed consent is a process

• A trained counsellor explains, & answers questions about, e.g.:– How the trial will work, the test vaccine, the risks & benefits involved &

the rights of volunteers & trial participants etc. (see Module 5 for more)

• Counsellor checks understanding, then asks volunteer to sign form

• Volunteer gets time to study the information & to ask questions

• Can take it away for a few days to read & to decide

• Must be free of all pressure & haveall the information they need

• Ongoing IC throughout the trial

Step 4

The informed consent form

• In the language the volunteer understands

• Must have clear & accurate information

• Contains names & numbers of key people, e.g. the PI, REC

• If changes to trial procedures, participants must be informed & the informed consent form updated & signed

• REC must approve changes & the updatedform before this happens

Step 4

Informed

Consent

If volunteers cannot read or sign the form

• There must be:– a neutral witness or a legally

acceptable representative

• He/she must be with the volunteer through the whole IC process

• If the volunteer decides to participate, this person should:– sign the informed consent form on the

volunteer’s behalf

Step 4

Enrolment (part 2) & first dose of the vaccine/placebo

• First collect baseline information via tests & medical check up– Shows status of the body, immune system & health

– Compare it to future data • To track changes & take action if necessary e.g. treat an adverse event

• Risk-reduction counselling– To prevent HIV infection, and or pregnancy

– Still a test vaccine - won’t necessarily prevent/treat infection

• First dose of vaccine or placebo, & observation for a few hours

Step 5

Enrolment (part 2) & first dose of the vaccine/placebo

Step 5

Monitoring for immediate adverse events

• Participants keep a trial diary for a few weeks after the dose

• How they feel physically & emotionally,& sexual behaviour

• Physical e.g. nausea

• Psychological e.g. anxiety

• Trial site staff must analyse & note changes & take necessary action

Step 6

Follow-up visits and doses

• Several follow up visits

• Check for safety & effects on the body by– Discussing trial diary

– HIV, pregnancy & other tests

– Medical check up

• Dose of vaccine/placebo, but not at every visit

• May be telephone interviews between visits

• Ongoing informed consent

Step 7

Data is analysed by researchers• Done at certain points in the trial

• Usually by the Data Safety Monitoring Board (DSMB) or Independent Data Monitoring Committee (IDMC)

• Results submitted to relevant parties e.g. regulatory authority, REC

• Results may be published for peer review

• If promising results, Sponsor may apply to do next phase of trials, or for licensure

Step 8

Feedback and unblinding interviews

• Once trial results available

• Participants invited to a final interview

• Trial site staff explain the results

• And whether they got the vaccine/placebo– called unblinding

• Discuss long-term follow up

Step 9

Long-term follow up of participants

• Participants are followed up after the trial

• People are unlikely to get further doses of the vaccine or placebo if: – they become pregnant during the trial, or

– they have a breakthrough infection (become HIV-positive) during a preventative trial.

• Those with breakthrough infectionswill be followed up for several years– to monitor treatment & disease progression.

Step 10

Deciding whether to take the vaccine candidate to the next phase

• Only the most promising vaccine candidates will go through to:– the next phase of clinical trials, or

– application for licensure

Step 11