Eurosupport 6: Testing the effectiveness of a computer-assisted counselling intervention on safer sex (CISS) for people living with HIV (PLHIV)

Due to medical treatment advances, greater numbers of HIV-infected persons are
living with HIV infection in good health for longer periods of time. The focus
of medical care has thus shifted from preventing death to increasing the
quality of life, of which sexual and reproductive health and rights (SRH&R) is
an important part. Research has shown that PLHIV prioritize sexual well being
as a topic. There is considerable evidence that women and men living with HIV
need support in fulfilling their sexual and SRH&R, including support for HIV
transmission risk reduction, i.e. adoption of safer sex. Health care providers
can play a critical role in providing this support.

- To develop evidence-based and theory-guided target group specific
interventions to improve the SRH of two specific groups of PLHIV, MSM and
migrants, with particular emphasis on reduction of HIV transmission behaviour.
- To test the effectiveness of this intervention on reduction of sexual risk
behaviour (i.e. unprotected vaginal or anal intercourse) at 3 months
post-intervention - as compared to baseline - in HIV clinical care and
community-based settings.
- Additionally, the sustainability of the behavioural change will be assessed
at 9 months post-intervention.

This is a randomised clinical trial, which compares a face-to-face counselling
intervention of 3 individually tailored sessions delivered by trained service
providers to the condition of standard care.

The CISS is to be provided as a CD-rom to all Eurosupport6 participating
centres. It will provide the guided focus of the counselling intervention. The
role of the counsellor will be to support the client in his or her use of the
CISS with the objective to make informed decision on safer sex behaviour and
achieve a reduction in HIV transmission risk reduction behaviour.
The CISS has different parts or modules which we will call *kisses* for now.
The CISS has certain underlying assumptions:
• It is important for clients to direct the way in which they choose which
*kisses* they access as this provides an individually targeted approach.
• There is no need for the client to access all *kisses*.
• The CISS presents materials in a way which is informal, emotive and which
reminds clients of sexual situations
• CISS presents materials in a culturally appropriate way. We recognize that
*migrants* are a heterogeneous group, therefore CISS targets rather the
specific vulnerabilities that migrants share with respect to HIV and SRH rather
than representing a specific migrant culture.
• CISS presents materials for heterosexual migrants in a gender-sensitive way,
i.e. materials contain specific issues adapted to the diverse needs of women
and men living with HIV
• The role of the counsellor is to be accepting of the client*s difficulties
with safer sex and to work in a collaborative way with the client on the CISS
materials.

Different visual materials - pictures, audio transcripts, video suggestions
will be included to support the non-directive, and client-centred counselling
process that uses elements of motivational interviewing in terms of the
counselling technique. The basic skills will be trained in the workshops and
will also be integrated in the online training tool to be developed. Training
intercultural competencies also forms an important part of the skills training
for service providers in the ES 6 training workshop and training materials.

For further details of the CISS elements, see Annex 3 in the study protocol.

As in any trial, there is a potential risk involved relating to the
randomisation to the treatment condition. Potential participants are informed
of randomisation prior to enrolment, and an explanation of random assignment to
the treatment group is being provided in the consent form. Referrals to other
health care or community services providing counselling and support are
available to all participants regardless of whether they are in the
intervention or control condition. Assessment staff is trained to detect
potential needs for referral and to provide such referrals throughout the
course of the study.
The staff implementing the intervention is recruited among trained and
experienced counsellors in HIV- or sexual health-care. On top of their general
training and experience, they receive a specific two day training to help them
to offer this intervention in an optimal way.

The first step is to fill out a computer questionnaire to see whether one is
eligible to join the study. This will take about 5 minutes. At the end of this
first brief questionnaire participants get immediate feedback to tell whether
they are eligible. If they are not, nothing else will happen. If they are,
they will have a new set of questions to do. This second questionnaire will
take about 30 minutes. After having taken this questionnaire, they will be
assigned - at random - either to the side of the study where you see and use
the computer materials, with the support of someone here, or else to the side
of the study where you don*t see the materials, but they get the support that
is usually offered at the clinic.
In the CISS arm of the study participants will meet with a counsellor at the
clinic to be introduced to the materials. There will be 3 meetings altogether
over a period of about 6 weeks. The counsellor will show the participant how
to use these materials and then give a CD-ROM which the participant can take
home, so that he/she can look at it alone. One session will last about 45 - 50
minutes. There will also be some questionnaires to complete:
- At the beginning of the study;
- After 6 weeks (after the 3 counselling sessions);
- 3 months later;
- 6 months after the latter.
If the participant chooses this, he/she will be given the DVD to use by
him-/herself at home.
The participant will be asked personal questions about sex, about mood and
other things that matter to him/her. By joining in the study, the participant
agrees to answer these questions as best as he/she can, although the
participant is also always free not to answer questions he/she doesn*t want to.
Some of the questions and computer-materials may raise unpleasant feelings
since they could be perceived as very intimate and personal, however, the
utmost best has been done to phrase everything in a very sensitive way.