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Intervention Summary

Choosing Life: Empowerment! Action! Results! (CLEAR) Program for Young People Living With HIV

The Choosing Life: Empowerment! Action! Results! (CLEAR) Program for Young People Living With HIV targets HIV-positive adolescents and young adults (aged 16-29 years) and is designed to prevent the transmission of HIV by reducing substance use and unprotected sex. The manual-driven CLEAR intervention is delivered by a facilitator who trains the client to identify situations that are most likely to positively modify the client's patterns of substance use, to successfully negotiate the use of condoms with sexual partners, and to identify long-term life goals, despite having a positive HIV serostatus. The facilitator works with the client through role-plays and rehearsals of difficult scenarios regarding HIV risk behavior, which are tailored to the client's anticipated experiences. The client also learns to anticipate situations that trigger negative emotions (e.g., anxiety, depression, fear, anger), apply a "Feeling Thermometer" to the situation to approximate the level of emotional intensity, and employ strategies (e.g., relaxation, self-instruction, meditation) to neutralize the negative emotions.

Facilitators conduct one-on-one, weekly sessions with clients; these sessions are typically held in private rooms at AIDS clinics, but they also can be conducted in community centers that serve young people living with HIV or in a client's home (if the home is judged to be safe and private). Each facilitator (i.e., a master's-level licensed therapist, clinical social worker, or experienced peer health worker) is trained to deliver the intervention and is supervised on a biweekly basis.

In the research reviewed by NREPP, CLEAR was delivered in person or by phone and consisted of 18 sessions, with 6 sessions covering each of three core modules: improving physical health, reducing substance use and using condoms during sex, and improving emotional mental health. However, the current version of CLEAR, which is being disseminated by the Centers for Disease Control and Prevention (CDC) through the Diffusion of Effective Behavioral Interventions (DEBI) project, consists of 5 core skill sessions, 21 sessions chosen by the client from a menu of six domains (substance use, sexual behaviors, disclosure, stigma, medication adherence, and health care), and a wrap-up session. The change in the number of sessions does not alter the original content of the intervention; rather it emphasizes the client-centered approach by which the intervention is tailored to meet the needs of each client.

Descriptive Information

Areas of Interest Substance use disorder treatment
Outcomes
1: Substance use frequency
2: HIV sexual risk behavior (condom use)
Outcome Categories Drugs
Ages 18-25 (Young adult)
Genders Male
Female
Races/Ethnicities Black or African American
Hispanic or Latino
White
Race/ethnicity unspecified
Settings Outpatient
Home
Other community settings
Geographic Locations Urban
Implementation History CLEAR was adapted from the Teens Linked to Care intervention for youth living with HIV--from a small group format to an individual format--and was first implemented with 175 participants in a randomized clinical trial funded by the National Institute on Drug Abuse. CLEAR also was culturally adapted and implemented in a research trial in Uganda, with 50 participants receiving the intervention. CLEAR has been disseminated through CDC's DEBI project, and CDC offers CLEAR both as a stand-alone intervention and as the core intervention for the Comprehensive Risk Counseling and Services program. CLEAR has been implemented in 20 States by 30 community-based and AIDS service organizations that have been trained to deliver the intervention.
NIH Funding/CER Studies Partially/fully funded by National Institutes of Health: Yes
Evaluated in comparative effectiveness research studies: Yes
Adaptations In partnership with the Uganda Youth Development Link, CLEAR was adapted for use in reducing the sexual risk behaviors of youth living with HIV in Kampala, Uganda. Findings from a study conducted to examine the effectiveness of this adaptation were published in Prevention Science.
Adverse Effects No adverse effects, concerns, or unintended consequences were identified by the developer.
IOM Prevention Categories IOM prevention categories are not applicable.

Quality of Research

Documents Reviewed

The documents below were reviewed for Quality of Research. The research point of contact can provide information regarding the studies reviewed and the availability of additional materials, including those from more recent studies that may have been conducted.

Outcomes

Outcome 1: Substance use frequency
Description of Measures Substance use frequency was measured by each participant's self-report of the number of days and the average number of times per day in the past 3 months he or she used cocaine, crack cocaine, inhalants, marijuana, opiates, methamphetamines, and stimulants.

Participants were assessed with audio computer-assisted self-interviewing (ACASI) technology at baseline and at 3, 6, 9, and 15 months after baseline (follow-ups).
Key Findings In a multisite randomized clinical trial, HIV-positive and drug-using adolescents and young adults (aged 16-29 years) referred from AIDS clinics and community-based sites in three cities (Los Angeles, New York, and San Francisco) were assigned to one of three conditions: one-on-one, in-person delivery of the intervention (in-person CLEAR); one-on-one telephone delivery of the intervention (telephone CLEAR); or a delayed-intervention control. From baseline to the 15-month follow-up:

  • Among participants still using substances, those assigned to the intervention conditions reported less frequent use of the following substances in comparison with those assigned to the control condition: crack cocaine (in-person CLEAR vs. control, p < .001; telephone CLEAR vs. control, p < .001), marijuana (in-person CLEAR vs. control, p < .001; telephone CLEAR vs. control, p < .001), and methamphetamines (in-person CLEAR vs. control, p < .001; telephone CLEAR vs. control, p < .001).
  • Among participants still using substances, those assigned to the telephone CLEAR condition reported less frequent use of stimulants than those assigned to the control condition (p < .001), and those assigned to the in-person CLEAR condition reported less frequent use of inhalants than those assigned to the control condition (p < .001).
Studies Measuring Outcome Study 1
Study Designs Experimental
Quality of Research Rating 2.7 (0.0-4.0 scale)
Outcome 2: HIV sexual risk behavior (condom use)
Description of Measures HIV sexual risk behavior (condom use) was measured by each participant's self-report of the following items over the past 3 months: total number of sexual partners, total number of sexual acts, and number of specific sexual acts with each partner, as well as whether condoms were used during each of these sexual acts. A sexual partner was defined as a male or female with whom the participant engaged in vaginal or anal sex. A sexual act was defined as a single session of receptive or insertive vaginal or anal sex. The proportions of vaginal and anal sex acts protected by condoms with all partners, HIV-positive partners, and HIV-negative partners (or partners of unknown status) were calculated for each participant.

Participants were assessed with ACASI technology at baseline and at 3, 6, 9, and 15 months after baseline (follow-ups).
Key Findings In a multisite randomized clinical trial, HIV-positive and drug-using adolescents and young adults (aged 16-29 years) referred from AIDS clinics and community-based sites in three cities (Los Angeles, New York, and San Francisco) were assigned to one of three conditions: one-on-one, in-person delivery of the intervention (in-person CLEAR); one-on-one telephone delivery of the intervention (telephone CLEAR); or a delayed-intervention control. From baseline to the 15-month follow-up:

  • The proportion of protected sexual acts (i.e., condom use) with all sexual partners increased for participants assigned to the in-person CLEAR condition compared with those in the control condition (p < .01). The proportion of protected sexual acts with all partners did not differ significantly between participants assigned to the telephone CLEAR condition and those assigned to the control condition.
  • The proportion of protected sexual acts with HIV-negative partners increased for participants assigned to the in-person CLEAR condition compared with those assigned to the telephone CLEAR condition (p < .01).
Studies Measuring Outcome Study 1
Study Designs Experimental
Quality of Research Rating 2.8 (0.0-4.0 scale)

Study Populations

The following populations were identified in the studies reviewed for Quality of Research.

Study Age Gender Race/Ethnicity
Study 1 18-25 (Young adult) 77.7% Male
22.3% Female 		42.3% Hispanic or Latino
26.3% Black or African American
23.4% White
8% Race/ethnicity unspecified

Quality of Research Ratings by Criteria (0.0-4.0 scale)

External reviewers independently evaluate the Quality of Research for an intervention's reported results using six criteria:

  1. Reliability of measures
  2. Validity of measures
  3. Intervention fidelity
  4. Missing data and attrition
  5. Potential confounding variables
  6. Appropriateness of analysis

For more information about these criteria and the meaning of the ratings, see Quality of Research.

Outcome Reliability
of Measures 		Validity
of Measures 		Fidelity Missing
Data/Attrition 		Confounding
Variables 		Data
Analysis 		Overall
Rating
1: Substance use frequency 2.3 2.5 3.5 3.4 2.0 2.8 2.7
2: HIV sexual risk behavior (condom use) 2.8 2.6 3.5 3.4 2.0 2.8 2.8

Study Strengths

An earlier study with a similar sample population had high test-retest reliability for the measurement items underlying the HIV sexual risk behavior outcome. The use of an ACASI assessment format has independent support for increasing the validity of self-reported substance use and sexual behavior in this population. The intervention was manual driven and delivered by interventionists who had relevant academic degrees and who participated in a 3-day curriculum training. The implementation of intervention sessions was either audiotaped (telephone delivery) or videotaped (in-person delivery), and a random selection of taped sessions was rated for intervention fidelity, which confirmed that more than 80% of the selected intervention sessions exceeded protocol criteria and process measures for fidelity. Ninety-five percent of eligible adolescents and young adults agreed to participate in the study, and follow-up rates were adequate to good (e.g., 78% at the 6-month follow-up, 86% at the 3- and 9-month follow-ups) and similarly distributed across the three study locations. Random assignment controlled for many potential confounding variables, the comparison to a delayed-intervention control was appropriate, and an intent-to-treat model used all of the data in mixed-effect regression analyses.

Study Weaknesses

No sample reliability statistics were presented for the substance use or HIV sexual risk behavior measurement items, although they were adapted from parent instruments and went through several iterations in previous studies. Self-reported substance use and HIV sexual risk behavior data were not independently validated by collateral reports from friends, parents, or main sexual partners, and the agreement of self-reported data with urine drug screens for cocaine or crack cocaine with a subset of participants at baseline was low (33%; kappa = .31). From baseline to the 15-month follow-up, participants in the delayed-intervention control condition had a reduction in substance use and fewer sexual partners, which suggests that repeated assessments alone (i.e., without the delivery of a prevention intervention) might account for some of the outcome findings. The level of incentive payments to retain participants in the study may have introduced a demand bias, and no information was provided regarding other services or interventions that study participants may have received during the follow-up period.
Readiness for Dissemination

Materials Reviewed

The materials below were reviewed for Readiness for Dissemination. The implementation point of contact can provide information regarding implementation of the intervention and the availability of additional, updated, or new materials.

CLEAR Wall Charts:

  • Feeling Thermometer
  • Guidelines for Good Weekly Goals
  • SMART Problem-Solving Steps

Klosinski, L., Elia, C., Swendeman, D., & Payne, J. Choosing Life: Empowerment! Action! Results! Comprehensive risk and counseling services. [PowerPoint slides]. Los Angeles: University of California, Los Angeles, Center for Community Health and Semel Institute for Neuroscience and Human Behavior.

Overview of Core Session Activities and Elements

Project CLEAR Client Flow Chart

Rotheram-Borus, M. J., & Klosinski, L. E. CLEAR: Choosing Life: Empowerment, Action, Results! A one-on-one intervention with youth and adults living with HIV/AIDS or at high risk for HIV infection--Implementation manual. Los Angeles: University of California, Los Angeles, Center for Community Health and Semel Institute for Neuroscience and Human Behavior.

Rotheram-Borus, M. J., Klosinski, L. E., & Elia, C. CLEAR: Choosing Life: Empowerment, Action, Results! A one-on-one intervention with youth and adults living with HIV/AIDS or at high risk for HIV infection--Technical assistance guide. Los Angeles: University of California, Los Angeles, Center for Community Health and Semel Institute for Neuroscience and Human Behavior.

Sample Implementation Budget for Provider Costs To Implement the Project CLEAR Intervention

Readiness for Dissemination Ratings by Criteria (0.0-4.0 scale)

External reviewers independently evaluate the intervention's Readiness for Dissemination using three criteria:

  1. Availability of implementation materials
  2. Availability of training and support resources
  3. Availability of quality assurance procedures

For more information about these criteria and the meaning of the ratings, see Readiness for Dissemination.

Implementation
Materials 		Training and Support
Resources 		Quality Assurance
Procedures 		Overall
Rating
3.5 2.9 3.8 3.4

Dissemination Strengths

The implementation materials for this program are thorough and easy to follow. A detailed agency readiness checklist and guidance on formulating an implementation plan (i.e., how to obtain buy-in from stakeholders, job descriptions, recommended staff workloads, qualifications for staff, time commitments of staff) are available online. Training is required for facilitators and strongly recommended for their supervisors, which helps to ensure that the program is delivered with fidelity. Supervisory training covers the observation of facilitators and encourages supervisors to observe facilitators either in person or via audio- or videotape to support quality assurance during implementation. The online evaluation field guide is extensive and well organized and explains how to approach the monitoring and evaluation of program processes and outcomes. Forms and instruments facilitate data collection for monitoring and evaluation purposes. A helpful protocol for monitoring session-by-session fidelity includes an option for tracking and providing a rationale for implementation changes that deviate from the program model.

Dissemination Weaknesses

Information on the implementation process is spread across documents, making it difficult to obtain a full overview. The training presentation includes few details for the development of a deeper understanding of the elements of the program model. Little guidance is provided on how to acquire training and technical assistance. Although there is considerable detail on what data to collect and how, little guidance is provided on using the collected data to improve program delivery.
Costs

The cost information below was provided by the developer. Although this cost information may have been updated by the developer since the time of review, it may not reflect the current costs or availability of items (including newly developed or discontinued items). The implementation point of contact can provide current information and discuss implementation requirements.

Item Description Cost Required by Developer
CLEAR implementation manual Free Yes
Online support materials (including implementation planning tools and wall chart files) Free No
10- to 15-day, on-site training (includes 30-minute, in-person consultation prior to training) $4,000 per participant, plus travel expenses No
Off-site training through regional, CDC-supported STD/HIV Prevention Training Centers (includes posttraining conference calls) Free No
CLEAR for Program Managers (Web-based training course) Free No
Phone or email consultation Free No
CLEAR technical assistance guide (includes evaluation field guide and fidelity and outcome monitoring tools) Free Yes