Posts classified under: Adherence

PRIDE

Adherence to therapy is now more important than ever in HIV/AIDS care due to recent advances in HIV therapeutics. Poor adherence to antiretroviral drugs can result in the development of resistance by HIV to multiple drugs–and to whole classes of drugs. Such development of resistant HIV strains poses a potential public health danger. Large, multidisciplinary trials to determine how to effectively improve medication adherence for HIV+ patients are urgently needed. Prior to such major trials, preliminary work is needed in a number of areas: (1) successful models of adherence and barriers to adherence need to be determined; (2) information regarding antiretroviral treatment needs to be simplified so that it is easily understandable to general populations; (3) interventions that rely on multiple disciplines and that utilize the best intervention strategies from the research on patient education, behavior change, and social support need to be developed; and (4) pilot trials need to be conducted.

The purpose of this study is to pilot an adherence intervention; this would be accomplished by the following four aims of this proposed study.

  1. Simplify antiretroviral treatment information regarding the rationale for adherence, benefits of adherence, and risks of nonadherence, so that the material is easily comprehensible to patients and can be utilized in a treatment adherence intervention.
  2. Through a series of small focus groups (total N = 35) with HIV-infected individuals currently prescribed antiretroviral therapy, identify successful techniques for adherence that they have utilized, as well as barriers; and obtain feedback on the simplified treatment information.
  3. Utilize focus group information to finalize an adherence intervention protocol that is preliminarily designed as a 5-session, tailored behavioral, mixed format intervention co-facilitated by a cognitive-behavioral therapist and a nurse: (1) a group session in which information regarding treatment and the rationale for adherence is discussed, and behavioral strategies are reviewed; (2) an individual meeting in which the patient receives assistance in developing their personal adherence plan by tailoring behavioral strategies; (3) a group session in which progress is reinforced, barriers are discussed, and participants engage in exercises designed to help them gain a sense of control in their health care planning and role-play ways to discuss issues with their providers; (4) an individual session to modify and strengthen the patient’s personal adherence program; and (5) a group session focused on long-term adherence maintenance.
  4. Conduct a small pilot, randomized, controlled trial in which 50 HIV-infected patients who have been prescribed antiretroviral therapy are assigned to one of two conditions: the tailored behavioral intervention or an assessment only control group, to determine if the intervention significantly increases medication regimen adherence, with patients assessed post-intervention and at 3 and 6 month follow-ups.

Because of the the rapid development of resistance, the fact that when resistance develops drug efficacy is lost forever, and due to cross-resistance several drugs may be lost, there is an urgent need to develop effective interventions. This multidisciplinary project seeks to provide information needed for large intervention trials.

 

 

Staying healthy: Taking Antiretrovirals Regularly (STAR)

Adherence with prescribed medication regimens is critically important for patients with HIV infection, due to recent advances in HIV therapeutics. Due to the unique nature of the drugs they take (e.g., rapid development of viral resistance when only minimal doses are missed) as well as complexity of the medication regimens, there is an urgent need to develop interventions to assist patients in medication compliance. Poor adherence to antiretroviral drugs not only can result in the development of resistance by HIV to multiple drugs, but to whole classes of drugs; resistant HIV strains pose a public health danger.

In this proposal the best strategies from prior adherence and behavior change research are utilized in an intervention trial that expands previous work in that it is: (1) interdisciplinary; (2) provides sufficient “dosage” or amount of intervention; and (3) includes booster maintenance sessions.

A sample of 144 HIV-infected men and women having difficulty adhering to their antiretroviral regimen will be randomly assigned to one of two conditions: a tailored behavioral group (TBG) intervention facilitated by a behavioral psychologist and a nurse practitioner, which includes social support and patient education; or a standard care condition (SC). Extended intervention and relapse prevention are needed for long-term adherence: this intervention consists of an initial 5 sessions and 4 booster sessions. All participants will be assessed at pre- and post-intervention, and at 3, 9, 15, and 21 month follow-ups.

The aims of the study are:
1. to determine whether a tailored, behavioral intervention that includes social support and patient education components and maintenance booster sessions promotes medication adherence and effective problem-solving related to medication compliance among HIV-positive individuals over long-term follow-up;
2. to determine the level of adherence that is maintained over time in the intervention group;
3. to determine if improvement in medication adherence is associated with less evidence of emotional and behavioral distress, and better quality of life;
4. to explore how medication adherence is associated with sexual transmission risk behaviors; and
5. to explore relationships between medication adherence and potential moderating and mediating variables (including self-efficacy and outcome expectancies related to adherence, behavioral intentions, coping methods, and health care satisfaction).
The results of this study will provide empirical data urgently needed by medical providers, public health agencies, community clinics, and other organizations as they attempt to develop medication adherence interventions for HIV-infected populations.

Choosing Life: Empowerment, Action, Results! (CLEAR) for Comprehensive Risk Counseling and Services (CRCS)

CLEAR-CRCS is an evidence based HIV prevention and health promotion intervention developed for people living with HIV enrolled in Comprehensive Risk Counseling and Services (CRCS). It is a client-centered program delivered one-on-one with clients who are having difficulty initiating or sustaining behaviors that prevent HIV transmission and reinfection. The program teaches clients cognitive-behavioral strategies to cope with triggers and other stressful situations that lead to risky behaviors and unhealthy choices. The goal of CLEAR-CRCS is to help these people maintain health, reduce transmission of HIV and infectious diseases, and improve their quality of life. CLEAR-CRCS is a product of extensive collaboration among researchers, staff from public and private agencies serving the population, and members of the intended population, representing diverse backgrounds and perspectives.

CLEAR-CRCS is structured such that the CRCS provider can individually tailor the program to address the unique needs of each client. The program consists of six foundational sessions that teach the core behavioral strategies of the program. Within these initial sessions, the client also develops a personal life goal and his or her prevention plan which will direct the focus of subsequent sessions. The provider then has a menu of 21 sessions to choose from in which the client can practice and apply the core strategies to realize his or her goals. The sessions in the menu address five domains: sexual behavior, substance use, treatment adherence, mental health, and successful disclosures.

Research on the original CLEAR Intervention: The original CLEAR study was conducted from 1999-2003 with an ethnically and culturally diverse group of substance using young people living with HIV/AIDS. The intervention was conducted as a multi-site trial in Los Angeles, San Francisco, and New York. The study demonstrated a significant increase in protected sexual acts, such as using condoms, with all partners and with HIV-negative partners.

Underlying Theory and Principles: The intervention was developed based on the social action theory. Social action theory stresses the importance of social interactions and environmental factors in a person’s ability to control behaviors that may endanger his or her health. It incorporates the principles that are expressed in traditional social-cognitive models of health-behavior change, including social-cognitive theory, the health belief model, and the transtheoretical model (stages of change). CLEAR-CRCS is predicated on the notion that behavior change depends both on a person’s belief that he or she can change a behavior (self-efficacy) and the beliefs that changing the behavior will result in a desired outcome (response efficacy).

Interventions, Training Manuals, etc. : 
For the most current CDC manuals please CLICK HERE visit the DEBI website.

Original RCT Protocol 1998-2002

  • Module 1
  1.   CLEAR- Mod 1, Sess 1: Identifying My Strengths: Creating A Vision for the Future. (1.5 hrs)
  2.   CLEAR- Mod 1, Sess 2: I'm HIV-Positive: Attitudes as Barriers to Future Goals. (1.5 hrs)
  3.   CLEAR- Mod 1, Sess 3: Making Commitments: Evaluating and Changing Substance Use. (1.5 hrs)
  4.   CLEAR- Mod 1, Sess 4: Seeing the Patterns: Why Do I Use Drugs and Alcohol? (1.5 hrs)
  5.   CLEAR- Mod 1, Sess 5: Beliefs: Thoughts That Influence My Substance Use Patterns. (1.5 hrs)
  6.   CLEAR- Mod 1, Sess 6: Future Goals: The Impact of Using Drugs and Alcohol. (1.5 hrs)
  • Module 2
  1.   CLEAR- Mod 2, Sess 7: Higher Self and Sexual Decisions: Facing the Challenges. (1.5 hrs)
  2.   CLEAR- Mod 2, Sess 8: Higher Self and Sexual Decisions: Changing Risk Behaviors. (1.5 hrs)
  3.   CLEAR- Mod 2, Sess 9: Making Sexual Decisions: Having Safety and Pleasure. (1.5 hrs)
  4.   CLEAR- Mod 2, Sess 10: Making Sexual Decisions: Can I Use Condoms (Correctly)? (1.5 hrs)
  5.   CLEAR- Mod 2, Sess 11: Making Sexual Decisions: Can I Influence My Partner To Use Condoms? (1.5 hrs)
  6.   CLEAR- Mod 2, Sess 12: Making Sexual Decisions: How Do I Refuse Unprotected Sex? (1.5 hrs)
  • Module 3
  1.   CLEAR- Mod 3, Sess 13: Motivation for Change: Wanting to Stay Healthy (1.5 hrs)
  2.   CLEAR- Mod 3, Sess 14: Attending Health Care Appointments (1.5 hrs)
  3.   CLEAR- Mod 3, Sess 15: Participating In Medical Care: Communication and Decision-making Skills (1.5 hrs)
  4.   CLEAR- Mod 3, Sess 16: Medication Schedules: Can I Stay on Track? (1.5 hrs.)
  5.   CLEAR- Mod 3, Sess 17: Medication Schedules: More Tools to Stay on Track (1.5 hrs)
  6.   CLEAR- Mod 3, Sess 18: Maintaining My Progress: Focus on the Future. (1.5 hrs)
  •  Workbooks
  1. CLEAR Individual Workbook I (Prevention for HIV Positive Adult and Youths)
  2. CLEAR Individual Workbook II (Prevention for HIV Positive Adult and Youths)
  3. CLEAR Individual Workbook III (Prevention for HIV Positive Adult and Youths)

Telephone Conference Call Groups

NOTE:  The original randomized controlled trial had a telephone group format that was not feasible for youth at that time.  Only the 1st module was completed, but it is in included here for reference.  The activities can be adapted and used for more current interventions.

 

Surveys and Scales Used:

 
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