Description
Core Elements, Key Characteristics, and Procedures
Adapting
Resource Requirements
Recruitment
Policies and Standards
Quality Assurance
Monitoring and Evaluation
Key Articles and Resources
References

Description

CLEAR (Choosing Life: Empowerment, Action, Results!) is an evidence-based HIV prevention and health promotion intervention for youth and adults (ages 16 or older) living with HIV/AIDS or at high risk for HIV. This individual-level intervention uses cognitive-behavioral techniques within a client-centered model to motivate people to change behavior. CLEAR can be implemented as a stand-alone intervention or integrated into Comprehensive Risk Counseling and Services programs. Because of the way CLEAR is designed (i.e., 5 required core skill sessions, 21 menu sessions, and a wrap-up session), counselors can tailor the intervention to fit each client's unique circumstances.

CLEAR has been packaged by CDC's Diffusion of Effective Behavioral Interventions project. Information on training and related materials on the intervention is available at The Diffusion of Effective Behavioral Interventions (DEBI) website.

Goals

CLEAR aims to help clients maintain health, reduce transmission of HIV and other sexually transmitted diseases, and improve their quality of life.

How It Works

CLEAR is unique in that it not only focuses on HIV prevention but provides clients with the skills to make healthy choices in all areas of their lives. In other words, it addresses the client's overall life context. Life goals often are at the forefront of clients' minds and help motivate clients to avoid making decisions that might harm their health or prevent them from reaching their dreams. Therefore, CLEAR is structured to focus first on clients' life goals and then on HIV prevention goals.

The intervention starts off with 5 required core skill sessions, during which the counselor introduces the core elements and the client learns the essential cognitive-behavioral techniques (e.g., reframing, positive self-talk, relaxation) of CLEAR. By the end of the 5 core skill sessions, the client (with the help of the counselor) identifies both a life goal and 1 or more prevention goals on which to focus during the remainder of the program. The client's prevention goals drive the selection of the menu sessions.

Using the individual prevention plan developed in core skill session 5, the counselor selects sessions from a menu of 6 domains to assist the client in achieving his or her prevention goals. Each client does not have to complete sessions in each of the 6 domains; the counselor should only implement the domains that are germane to the client's prevention goals. Moreover, the counselor must select the menu domains based on the order of the prevention goals prioritized by the client. The 6 domains address sexual risk, substance use risk, health care and self-care, medication adherence, disclosure, and HIV stigma. Each domain consists of 2 to 6 sessions that help clients practice the cognitive-behavioral techniques that were introduced in the core skill sessions. After the menu sessions are complete, a final wrap-up session addresses the maintenance of behavioral changes made in the program.

Theory Behind the Intervention

The CLEAR intervention is based on Social Action Theory, which asserts that a person's ability to change behaviors that endanger his or her health is influenced by the individual's self-change process (i.e., cognitive capability, information, self-efficacy, outcome expectancies, social skills, self-regulating skills, rewards) and contextual factors (i.e., environmental factors and social interactions) that encourage or discourage the change process.

CLEAR was designed to address the self-change process of the model by building clients' problem-solving and negotiation skills and increasing clients' self-efficacy to change behaviors.¹

Research Findings

The original CLEAR intervention was evaluated with 175 HIV-positive people living in Los Angeles, San Francisco, and New York.² Participants were ages 16-29, 26% were black, 42% were Latino, and 69% were gay men. They were assigned to a 3-module intervention that consisted of 18 sessions, delivered by telephone, in person, or a delayed-intervention condition. After the intervention, the proportion of protected sexual acts increased for all partners (and especially HIV-negative partners) among participants who received the in-person intervention. In addition, participants who received the in-person intervention had a larger decrease in the number of HIV-negative partners than did those in the control group.

During preparation for its use in the field, CLEAR was modified to make implementation easier. For example, the number of intervention sessions was reduced from 18 sessions to 5 core skill sessions and additional menu sessions. This change in the number of sessions did not change the content of the curriculum. Further, all of the core elements responsible for CLEAR's effectiveness were maintained.

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Core Elements, Key Characteristics, and Procedures

Core Elements

Core elements are critical components of an intervention's conceptualization and design that are believed to be responsible for the intervention's effectiveness. These core elements are derived from the behavioral theories on which the intervention or strategy is based. Core elements are essential and cannot be ignored, added to, or changed, in order to maintain intervention fidelity and intent.

CLEAR has the following 5 core elements:

• Development of emotional awareness through use of a “feeling thermometer” and identification of the link between feelings, thoughts, and actions (Feel-Think-Do framework).
• Identification of one's ideal self to help motivate and personalize behavior change.
• Teaching, modeling, and practicing short- and long-term goal setting.
• Teaching, modeling, and practicing SMART (Self-Management and Recovery Training) problem solving.
• Teaching, modeling, and practicing assertive behavior and communication.

Key Characteristics

Key characteristics are those parts of an intervention (activities and delivery methods) that can be adapted to meet the needs of the community-based organization or target population.

CLEAR has the following 6 key characteristics:

• Use incentives to encourage clients to return to sessions.
• Complete each session in 60 to 75 minutes.
• Conduct sessions once per week to allow clients time to practice new skills before the next session.
• Use experienced counselors or mental health professionals who have received formal clinical training.
• Deliver the intervention with a client-centered approach.
• Hold sessions in a room that ensures privacy and confidentiality and is free from interruptions.

Procedures

Procedures are detailed descriptions of some of the elements and characteristics listed above. Some of the procedures for CLEAR are as follows:

Pre-assessment to establish eligibility

Before implementing CLEAR, agencies should determine eligibility criteria and communicate this information to potential referral sources. When potential clients have been identified, agencies should conduct a brief pre-assessment to ensure that clients are eligible to participate in the program. At a minimum, clients should have at least a moderate level of motivation to make changes in high-risk behaviors related to any of the 6 menu domains: 1) substance use risk, 2) sexual risk, 3) health care and self-care, 4) medication adherence, 5) disclosure, and 6) HIV-related stigma. Level of motivation can be gleaned from a client's history of keeping commitments to goals and tasks, expressed desire to seek support for general life or HIV-related stressors, or past attempts to seek support or participate in therapy or intervention programs.

Ongoing assessment

In CLEAR, counselors do not conduct client assessments just at the beginning of the intervention. Rather, the counselor gathers information from the client in an informal manner throughout his or her relationship with the client. Through this process, the counselor and the client work together to identify the client's life goals and develop an individualized prevention plan. The life goals and prevention plan inform the menu selections.

Conducting CLEAR sessions

CLEAR sessions should occur on a weekly basis and be delivered by using a client-centered approach. Using this approach, the counselor lets the client dictate the priority of various goals and does not attempt to push an HIV-prevention agenda on the client. This is not to say that HIV prevention is not a focus of CLEAR; a skilled counselor will be able to create concern in clients about high-risk behaviors by tying these in with the client's general life concerns.

Core skill sessions

There are 5 core skill sessions. Each of the sessions should be implemented sequentially, starting with core skill session 1 and ending with core skill session 5:

• Getting to Know Each Other
• Creating a Vision for the Future
• Stressors and SMART Problem Solving
• Exploring Different Types of Communication
• Putting It All Together

Menu sessions

There are 21 menu sessions that fall under 6 domains. Like the core skill sessions, the menu sessions in each domain must be implemented sequentially. However, the counselor should begin with whatever domain was prioritized on the basis of the prevention goal the client chose to focus on first.

Domain 1: Sexual Risk (6 sessions)

• Understanding Why I Have Unsafe Sex
• How to Use Condoms (Correctly)
• Can I Influence My Partner to Use Condoms?
• Can I Influence My Partner to Engage in Safer Sex?
• How Do I Refuse Unsafe Sex?
• Should I Disclose My Status to My Sexual Partner(s)?

Domain 2: Substance Use Risk (5 sessions)

• Setting a Foundation for Change
• What Are My External Drug and Alcohol Triggers?
• What Are My Internal Drug and Alcohol Triggers?
• What Will Help Me Achieve My Goal Related to Injection Drug Use?

Domain 3: Health Care and Self-Care (3 sessions)

• Motivation for Change: Wanting to Stay Healthy
• Attending Health Care Appointments
• Partnering in My Care and Treatment

Domain 4: Adherence (3 sessions)

• Understanding My Medications and Adherence
• What Affects the Way I Take My Medications?
• How Can I Discuss Medications with My Health Care Provider?

Domain 5: Disclosure (2 sessions)

• Should I Disclose My Status?
• When and How Should I Disclose My HIV Status?

Domain 6: Stigma (2 sessions)

• How Can I Cope with Internal Stigma?
• How Can I Cope with External Stigma?

Termination

After addressing each of the client's prevention goals, the counselor conducts a wrap-up session to bring closure to the client's experience with CLEAR. This final session is designed to help the client develop maintenance strategies for sustaining new behaviors, provide an opportunity for the client to reflect on his or her experiences in CLEAR, and give the client his or her workbook, which can be used as a future resource.

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Adapting

CLEAR can be used in a variety of settings where people are living with HIV/AIDS or have behaviors that put them at high risk for HIV. Because CLEAR is designed to address the unique needs of each client through the menu sessions, it is easily adaptable. In addition, CLEAR can be used as a structured approach to conducting comprehensive risk counseling and services.

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Resource Requirements

Counselors

CLEAR requires trained counselors or mental health professionals. In the original intervention study, CLEAR was delivered by people who either held a master's degree or were enrolled in a doctoral program in psychology, social work, or public health. Counselors with the following combination of skills and experience will be most successful in delivering CLEAR:

• Knowledge of HIV/AIDS.
• Knowledge of the target population.
• Past direct experience with the target population (children and adults living with HIV/AIDS or at high risk for HIV).
• Previous clinical training.
• Understanding of and experience working from a cognitive-behavioral theoretical orientation.
• Previous experience in delivering structured interventions.
• Bachelor's or graduate degree in psychology, social work, or related field.
• Cultural sensitivity.

Clinical Supervisors

Counselors should participate in weekly group or individual clinical supervision in order to debrief about existing clients. Clinical supervision should be facilitated by a licensed clinician (e.g., clinical psychologist, marriage and family therapist, social worker) who has a strong background in cognitive-behavioral therapy.

Clinical supervision typically addresses the following areas:

• Counselors' personal feelings that may have surfaced during the session with the client.
• Clinical issues (e.g., family of origin concerns, history of trauma) that arose during the session.
• Delivery of the session from a clinical perspective.
• Delivery of the session from a client-centered perspective.
• Adherence to the intervention's curriculum and integration of core elements.

Confidential Space

CLEAR sessions should be conducted in a comfortable space that is free from interruptions. Clients will be able to best learn new skills, share their life experiences, and develop trust in themselves and the counselors if sessions are held in a friendly, informal atmosphere where confidentiality is ensured. This space should include a table for taking notes and reviewing various handouts.

Materials

The CLEAR intervention package includes several helpful worksheets, handouts, and templates:

• Feeling thermometer.
• F-T-D grid.
• Weekly goal cards.
• Guidelines for good goals.
• SMART problem-solving steps.
• Individual prevention plan worksheet.
• Life goals worksheet.

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Recruitment

Agencies should have a recruitment plan in place that details how clients will be recruited, including recruitment venues, recruitment and marketing tools, and number to be recruited. An agency's community advisory group should be able to help to develop this plan. Agencies implementing CLEAR may be most successful at recruiting and retaining clients from partner agencies that offer related services (e.g., Ryan White case management, substance abuse treatment, mental health services, counseling and testing). In addition, clients can be recruited via street outreach by using flyers or brochures, or via word-of-mouth from previous clients.

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Policies and Standards

Before a CBO attempts to implement CLEAR, the following policies and standards should be in place to protect clients, the CBO, and the CLEAR intervention team.

Confidentiality

A system must be in place to ensure that confidentiality is maintained for all participants in the program. Before sharing any information with another agency to which a client is referred, signed informed consent from the client or his or her legal guardian must be obtained.

Cultural Competence

CBOs must strive to offer culturally competent services by being aware of the demographic, cultural, and epidemiologic profile of their communities. CBOs should hire, promote, and train all staff to be representative of and sensitive to different cultures. In addition, they should offer materials and services in the preferred language of clients, if possible, or make translation available, if appropriate. CBOs should facilitate community and client involvement in designing and implementing prevention services to ensure that cultural issues are incorporated. The Office of Minority Health of the Department of Health and Human Services has published the National Standards for Culturally and Linguistically Appropriate Services in Health Care, which should be used as a guide for ensuring cultural competence in programs and services. (Please see Ensuring Cultural Competence in the Introduction of these guidelines for standards for developing culturally and linguistically competent programs and services.)

Data Security

To ensure data security and client confidentiality, data must be collected and reported according to CDC requirements.

Informed Consent

CBOs must have a consent form that carefully and clearly explains (in appropriate language) the CBO's responsibility and the client's rights. Individual state laws apply to consent procedures for minors; at a minimum, consent should be obtained from each client and, if appropriate, a legal guardian if the client is a minor or unable to give legal consent. Participation must always be voluntary, and documentation of this informed consent must be maintained in the client's record.

Legal and Ethical Policies

If agencies offer HIV testing with CLEAR, clients will learn their HIV status when they return for their test results. CBOs must know their state laws regarding disclosure of HIV status to sex partners and needle-sharing partners. CBOs are obligated to inform clients of the organization's responsibilities if a client receives a positive HIV test result and the organization's potential duty to warn. CBOs also must inform clients about state laws regarding the reporting of domestic violence, child abuse, sexual abuse of minors, and elder abuse.

Referrals

CBOs must be prepared to refer clients as needed. For clients who need additional assistance in decreasing risk behavior, providers must know about referral sources for prevention interventions and counseling, such as comprehensive risk counseling and services, partner counseling and referral services, and other health department and CBO prevention programs.

Volunteers

If the CBO uses volunteers to assist with or conduct this intervention, the CBO should know and disclose how their liability insurance and workers' compensation applies to volunteers. CBOs must ensure that volunteers also receive the same training and are held to the same performance standards as employees. All training should be documented. CBOs must also ensure that volunteers sign and adhere to a confidentiality statement.

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Quality Assurance

Quality assurance is an ongoing process that ensures that counselors maintain fidelity to the core elements of the intervention. The following quality assurance activities should be in place when implementing CLEAR.

Counselors and Supervisors

Training

Both counselors and clinical supervisors should participate in training and continuing education to ensure that they have the requisite skills to implement CLEAR successfully. Program managers, executive directors and key stakeholders should participate in the overview webinar to ensure they are aware of CLEAR program planning, implementation, and evaluation issues.

Session observation

The clinical supervisor should observe the counseling sessions periodically to ensure that counselors are consistently adhering to the CLEAR protocol and are providing high-quality counseling. These observations may be done in person, or the counselor might videotape or audiotape the session for later review by the supervisor or peer-review groups. Before the clinical supervisor observes the session, the counselor must obtain the consent of the client.

Record review

Records should be reviewed regularly to ensure that counseling sessions are documented consistently and correctly, consent forms (signed either by the client, if older than 18 or emancipated, or by a legal guardian) are on file, and that notes are of sufficient detail to document that clients are participating actively.

Case conferences

Case conferences are an ideal opportunity for counselors and supervisors to obtain support from and provide constructive feedback to other staff in the agency. During case conferences, the counselors and supervisors can present challenging sessions, practice using the CLEAR intervention materials, and discuss strategies for better serving their clients. Peer role-playing can be a useful strategy during these meetings.

Clients

CLEAR staff should administer client satisfaction surveys to clients at the end of the 5 core skill sessions and then every 3 to 4 sessions thereafter. These anonymous surveys can be used to assess clients' satisfaction with the overall counseling experience, session components (e.g., development of the individual prevention plan), and counselor characteristics (e.g., display of empathy). Clients also should be given the opportunity to offer suggestions on how to improve the sessions.

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Monitoring and Evaluation

Specific guidance on the collection and reporting of program information, client-level data, and the program performance indicators will be distributed to agencies after notification of award.

General monitoring and evaluation reporting requirements for the programs listed in the procedural guidance will include the collection of standardized process and outcome measures. Specific data reporting requirements will be provided to agencies after notification of award. For their convenience, grantees may utilize PEMS software for data management and reporting. PEMS is a national data reporting system that includes a standardized set of HIV prevention data variables, web-based software for data entry and management. CDC will also provide data collection and evaluation guidance and training and PEMS implementation support services.

Funded agencies will be required to enter, manage, and submit data to CDC by using PEMS or other software that transmits data to CDC according to data requirements. Furthermore, agencies may be requested to collaborate with CDC in the implementation of special studies designed to assess the effect of HIV prevention activities on at-risk populations.

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Key Articles and Resources

• Comulada WS, Swendeman DT, Rotheram-Borus MJ, Mattes KM, Weiss RE. Use of HAART among young people living with HIV. American Journal of Health Behavior. 2003;27:389–400.
• Ewart CK. Social action theory for a public health psychology. American Psychologist. 1991;46:931–946.
• Lightfoot M, Rotheram-Borus MJ, Tevendale H. An HIV-preventive intervention for youth living with HIV. Behavior Modification. 2007;31:345–363.
• Lightfoot M, Swendeman D, Rotheram-Borus MJ, Comulada WS, Weiss R. Risk behaviors of youth living with HIV: pre- and post-HAART. American Journal of Health Behavior. 2005;29:162–171.
• Rotheram-Borus MJ, Lee MB, Murphy DA, Futterman D, Duan N, Birnbaum JM, Lightfoot M, and the Teens Linked to Care Consortium. Efficacy of a preventive intervention for youths living with HIV. American Journal of Public Health. 2001;91:400–405.
• Swendeman D, Rotheram-Borus MJ, Comulada S, Weiss R, Ramos ME. HIV-related stigma among young people living with HIV. Health Psychology. 2006;25:501–509.

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References

1. Lightfoot M, Tevendale H, Comulada WS, Rotheram-Borus MJ. Who benefited from an efficacious intervention for youth living with HIV: a moderator analysis. AIDS and Behavior. 2007;11:61–70.
2. Rotheram-Borus MJ, Swendeman D, Comulada WS, Weiss RE, Lee M, Lightfoot, M. Prevention for substance-using HIV-positive young people: telephone and in-person delivery. Journal of Acquired Immune Deficiency Syndromes. 2004;37(Suppl 2):S68–S77.

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