Understanding Research Voluntary Counseling and Testing
How is voluntary counseling and testing provided to volunteers in clinical research or vaccine trials?
Before a clinical trial of an AIDS vaccine candidate or a clinical research study takes place in a community, the essential components of a research and healthcare system must be in place. These components include infrastructure for a study site, training researchers and healthcare workers at study sites to counsel and test people for HIV, and a place to refer those in need for proper treatment. This is sometimes referred to as the three Ts (Training, Testing, and Treatment); without these there can be no trial.
Eligibility for enrollment in a vaccine trial or a clinical research study (see March Primer on Understanding Clinical Research Studies) will hinge upon whether a potential volunteer is infected with HIV, so everyone must have an HIV test. For AIDS vaccine trials potential volunteers can not be HIV-infected, but for other types of clinical research studies only HIV-infected individuals can enroll. HIV testing prior to joining a study is voluntary and the process is referred to as research voluntary counseling and testing (RVCT). These programs serve as the gateway to enrollment in studies. Other types of community-based VCT programs involve similar procedures but do not share the goal of enrolling people in a trial. The primary aim of community VCT programs is getting people to know their HIV status and undergo risk-reduction counseling so that they can protect themselves and their partners against HIV infection or be referred for care and treatment.
Like VCT, RVCT is confidential and seeks to help the volunteers understand the risk behaviors associated with HIV infection, the implications of the test results, and how they can reduce their future risk. RVCT also involves explaining what participation in a trial involves and getting the potential volunteer’s informed consent to participate in a clinical research or vaccine trial. During this process researchers ensure that volunteers understand what is involved in the trial before enrolling and that their participation is voluntary.
Different models are used to recruit people into RVCT programs where they can find out their HIV status and learn about how studies are conducted. Several methods of recruitment may be used from general community awareness, focus group discussions, and one-on-one interactions. All approaches involve strong community participation through community advisory boards—groups of people in the community that are familiar with the trial or study.
All volunteers meet with a trained counselor before having an HIV test. In this session the counselor provides each volunteer with basic information about HIV/AIDS and asks questions to determine the understanding of how HIV is transmitted and what methods of protection are available. An important part of RVCT is also explaining what type of research is being conducted at the specific site and informing the volunteer that they may be able to participate.
During pre-test counseling background information is discussed with each volunteer. Information is collected about the volunteer’s risk behaviors including sexual behavior, condom use, history of sexually-transmitted diseases, and use of injection drugs. Based on the information provided, the counselor will give explanations and recommendations on how to avoid and reduce the risk of HIV infection. If the volunteer joins the study this information may also be used to determine how his/her risk behavior may change over time. This will be analyzed by researchers at the site.
For volunteers considering joining an AIDS vaccine trial, the counseling session also covers the study procedures. These include regular HIV testing, use of contraceptive methods, duration of the trial, and the necessity of making all scheduled study visits. In an RVCT session the counselor will explain that some volunteers in the trial will receive an inactive substance, called a placebo, instead of the candidate vaccine. Most vaccine trials are double-blinded, which means that neither the doctor nor the volunteer knows who is receiving vaccine or placebo. RVCT counselors will also emphasize that the researchers do not know whether the vaccine candidate is protective or not, and that until Phase III efficacy trials show otherwise the vaccine candidate should be considered as not protective.
A volunteer may choose not to be tested for HIV after receiving pre-test counseling.
The type of HIV testing that is used may vary by site. Many sites now use the rapid HIV tests that require only a finger prick to collect a blood sample and test for the presence of antibodies against HIV. Results from these tests are available in just 15 minutes. Some trial sites will do two rapid tests at the same time so they can be more assured of the results. At sites where rapid tests are not available it is very important to ensure that volunteers return for their test results so they can receive the post-test counseling and be referred to healthcare facilities for HIV care and treatment should they be HIV-infected. For AIDS vaccine trials, more sophisticated HIV tests may be used in addition to the classic rapid tests to ensure accuracy.
Once the results are available the counselor will inform each person whether or not they are HIV infected and help them to understand the results. If the volunteer is not HIV infected the counselor will explain that there is a period of time (called a "window period") between when a person gets infected and when the body makes antibodies against HIV. Though they usually appear in three weeks, it can take up to three to six months for these antibodies to register on the test. If the volunteer reports risk behaviors in this window period then they may be asked to return for a repeat test.
Counselors will review ways for volunteers to reduce risk behaviors in the future, regardless of the test results. For volunteers who are HIV infected the post-test counseling will provide the volunteer with the opportunity to discuss their concerns. The counselor will help the volunteer set a plan of action, including notifying their partners or families finding ways to stay healthy, and referral for care and treatment available in the community.
RVCT has many benefits for communities. Research studies have shown that HIV incidence often declines in areas where extensive testing and public health campaigns promoting HIV education take place. People who know their HIV status are also likely to encourage other members of their community to be tested. This helps support enrollment in vaccine trials or clinical research studies.