Posts classified under: HIV+

Masihambisane – Pregnant Women: KZN

There are four intersecting epidemics among pregnant women in South Africa: hazardous alcohol use (30%), HIV (27%), TB (60% of HIV+), and malnutrition (24% of infants). Unless the prevention programs for these epidemics are horizontally integrated, there will never be adequate resources to address these challenges and stigma will dramatically reduce program utilization. Since clinics are the typical sites for treating each of these health problems, the NIMH-funded Masihambisane study is examining a clinic-based prevention program delivered by neighborhood Mentor Mothers (MM) to reduce the consequences of hazardous alcohol use, HIV, TB, and poor nutrition. The intervention encourages mothers to care for their own health, parent well, maintain their mental health, and, if the mother is living with HIV (HIV+ MAR), reduce HIV transmission and/or reduce alcohol use and abuse. The results begin to inform the optimal delivery strategy for next generation of preventive interventions in order to be feasible and sustainable for broad dissemination immediately following an efficacy trial.

Targeted Risk Group: 

Mothers at risk for hazardous alcohol use, HIV, TB, and malnutrition, as well as their infants

Published Journal Articles :

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Interventions, Training Manuals, etc. :  

Surveys and Scales Used: 

Intervention model:  
In the intervention arm, participants will receive the Department of Health-delivered Prevention of Mother to Child Transmission (PMTCT) program plus the Project Masihambisane mentor mothers support program, delivered by HIV-positive mentor mothers. HIV-positive mentor mothers are women who are thriving in the community and who have been through the PMTCT program. They have been recruited and trained to deliver the intervention to pregnant mothers living with HIV.

Research Methods: 

Eight clinics were randomly assigned to the intervention (4 clinics) or control condition (4 clinics). There are two levels of nesting in the study. Mothers and their infants are nested within clinics, and repeated observations over time are nested within individuals. Longitudinal random effect regression models will be used to account for the nesting and examine the efficacy of the intervention at improving the health of infants and their mothers over time.

Local Significance: 

The study is ongoing so it is too early to draw conclusions on the effectiveness of the intervention and the local significance.

International Significance: 

The study is ongoing so it is too early to draw conclusions on the effectiveness of the intervention and the local significance.

IMAGE Program

The incidence of HIV is high among women of childbearing age in the U.S., and mothers living with HIV (MLH) report their greatest source of stress is combining the maternal role with the psychological and medical demands of coping with a chronic, life-threatening condition.

The purpose of this R01 pilot study is to develop and then test the feasibility of implementing a parenting intervention for HIV-infected mothers with well children age 6–14 years old.  The intervention is designed to improve parenting skills and maternal self-care skills in order to improve child and maternal outcomes.  The basis for development of this intervention is work from two previous R01s (MH # 5R01MH057207, currently Yr. 12) designed to longitudinally assess HIV-positive mothers and their children.

MLH (n = 60) and their children (total N = 120) will be recruited, randomized to a theory-based, skills training intervention or a control condition, and assessed at baseline and 3, 6, and 12-month follow-ups.  The intervention (“Improving Mothers’ parenting Abilities, Growth, & Effectiveness”—the IMAGE program) will consist of 5 sessions, and will be based on the Information – Motivation – Behavioral Skills (IMB) model of health behavior change, with specific skills selected based on our 10-year observational study of MLH and their children, which is on-going at UCLA.  A random subset of 40% of the intervention mothers (n = 12) will be asked to participate in an in-depth qualitative interview after their last follow-up, to obtain detailed process information on their experiences in the intervention.

The main aims of this randomized pilot trial are to:

  1. Develop the intervention and then evaluate the feasibility and acceptability of implementing the 5-week, theory based, individual behavior intervention to enhance positive parenting skills of MLH; and
  2. Conduct preliminary evaluation of the data for effect sizes and investigate trends in the data for
      • Parenting practices outcomes (utilizing the parent practices scale), and secondary outcomes of parenting efficacy
      • Parenting behaviors targeted (parent-child communication, parental monitoring, family routines, and appropriate parentification) and the self-care skills targeted (social support, disclosure, dealing with perceived stigma)
      • Maternal outcomes for mental health indicators and physical health indicators
      • Child outcomes of mental health indicators, behavioral problems, and self-concept and coping
      • Family outcomes (family functioning, parent-child relationship)

We are now in the third decade of the HIV epidemic, and few interventions, other than for prevention or medication adherence, are available for women living with HIV; this study will be the first step in the evaluation an intervention that will assist HIV-positive mothers in dealing with the stress of parenting while coping with HIV. The pilot data will lead to a future application for a full-scale trial of the intervention to test efficacy.

Teens and Adults Learning to Communicate (TALC: NYC)

Teens and Adults Learning to Communicate

Project TALC was funded by the National Institute of Mental Health (NIMH) and is an intervention designed to improve behavior and mental health outcomes among parents with AIDS and their adolescent children. The study sample was comprised of 307 financially-needy, AIDS-infected parents in New York City and 412 adolescent children. The majority (80%) of the parents were mothers. Approximately one-half of the study participants were Latino and over one-third were African American.

Targeted Risk Group: 

AIDS-infected parents and their children

 Intervention model:

Cognitive behavioral intervention comprised of two modules. The first module was for parents only (8 sessions) and focused on coping with the HIV illness and disclosure. The second module was for parents and their adolescents (16 sessions) and focused on ways to plan a legacy, e.g. making custody arrangements.

 Research Methods: 

In a random assignment study, families assigned to take part in Project TALC were compared with families assigned to a control group on mental health and health behaviors, including sexual behavior and substance use. Because participants were followed over time, longitudinal random effect regression models were used to test the efficacy of the intervention.

 Local Significance: 

Over the two-year follow-up period, adolescents assigned to take part in the intervention reported significantly and substantially lower levels of emotional distress, conduct problems, and family-related stressors and higher levels of self-esteem than did control group adolescents.

 International Significance: 

Project TALC provided a behavioral intervention that can be adapted for other countries and cultures to improve behavior and mental health outcomes among parents with AIDS and their adolescent children.

Published Journal Articles:

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Please see TALC LA for the up-to-date intervention manuals.

Surveys and Scales Used: 

  1. Needle Use and Sharing - Survey
  2. Acculturation, Habits, and Interests Multicultural Scale for Adolescents (AHIMSA)
  3. Medication Adherence - Survey
  4. Self Harm: Suicide History - Survey
  5. CDC Sexual Behavior Questions (CSBQ)
  6. Health Belief Model: Self-Efficacy for Sexual Discussion (HBMSD) - Scale
  7. Self-Efficacy to Refuse Sexual Behavior (RSB) - Scale
  8. Self-Efficacy for Limiting Substance Use - Scale
  9. Self-Efficacy for Negotiating Condom Use - Scale
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  11. Detention and Jail History Assessment - Survey
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  13. Alcohol and Other Drug Abuse (AOD) - Scale
  14. Dealing with Illness - Scale
  15. Rosenberg Self-Esteem (RSE) - Scale
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  17. Parker Parental Bonding Instrument
  18. Network Assessment
  19. Life Events Assessment - Survey
  20. HIV Related Incidents - Survey
  21. Healthcare Utilization, Providers, and General Health Assessment: Including STD and Pregnancy - Survey
  22. HIV Testing Assessment - Survey
  23. Global HIV Competence Assessment - Scale
  24. Getting Services Assessment - Survey
  25. General Medical History Assessment
  26. Multiple Problem Behavior - DSM Conduct Problems (DSMC) - Conduct Disorder
  27. Composite International Diagnostic Interview (CIDI)

HIV Counseling & Texting Program

The HIV Counseling and Texting (HCT) program utilizes social networks testing methodology, specifically designed to work with HIV infected and high-risk gay and bisexual men of color and transgender women. HIV infected or high-risk negative participants who either come to the Friends Community Center site for services or are contacted through street outreach and meet eligibility are invited to serve as recruiters. The engagement of new recruiters will be an active and ongoing part of the program. Potential recruiters attend a group orientation, which explains the social network methodology and informs potential recruiters that they will be requested to recruit individuals from their social, sexual or drug-using networks whom they believe to be at high-risk of HIV infection. Following the training period (brief identification, group orientation, individual interview), the recruiter begins to locate network associates to be referred to our testing site. Confirmatory HIV tests and STI testing (syphilis, Chlamydia, gonorrhea) are also available at the Friends Community Center site. Participants (both those who test HIV negative and positive) are then linked to appropriate medical, social, psychological, CRCS and other needed services. Network associates who wish to become recruiters are be assessed for eligibility and appropriateness.

This program is funded by the Los Angeles County, Department of Health Services, Office of AIDS Programs and Policy (OAPP).

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.

Teaching, Raising, and Communicating with Kids (TRACK)

The purpose of this 3-year R01 is to test the preliminary efficacy of an intervention to assist HIV-infected mothers to disclose their serostatus to their young (age 6 – 12 year old), well children.

The basis for development of this intervention is work from two R01s (MH # 5R01MH057207, currently Yr. 09) designed to longitudinally assess HIV-positive mothers and their children, which included studies on maternal disclosure (e.g., Murphy, Marelich, & Hoffman, 2002; Murphy, Marelich, Hoffman, & Schuster, 2006; Murphy, Roberts, & Hoffman, 2002; Murphy, Roberts, & Hoffman, 2003; Murphy, Roberts, & Hoffman, 2006; Murphy, Steers, & Dello Stritto, 2001).  This research suggests disclosure is difficult for mothers living with HIV (MLWHs), and that outcomes for both mothers and children could be improved by the proposed intervention.

Information gathered in the previous two R01s will be used to develop a brief disclosure intervention.  MLWHs (N = 80) will be randomly assigned to the intervention or control condition.  MLWHs and children (N = 160) will be assessed at baseline, 3, 6, and 9-month follow-ups. A random subset of intervention mothers (n = 12) will be asked to participate in an in-depth qualitative interview after their last follow-up, to obtain detailed process information on their experiences in the study.

The aims of the intervention are to:  improve mother-child communication and parenting skills—particularly as they relate to disclosure.  As a result of the intervention aims, other primary and secondary outcomes include:  increasing readiness to disclose, and disclosure itself; improving both MLWH and child mental health indicators; reducing child behavioral problems, and improving the parent-child relationship and family functioning.

This study will provide important prospective, longitudinal data on MLWHs’ adjustment to having disclosed their serostatus, and their children’s adjustment to the disclosure. Previous research indicates that for some families, maternal and child psychological distress may increase immediately following disclosure, but will decrease over time; the longitudinal design of this study will allow us to follow mothers and children throughout the disclosure process.

The study will allow evaluation of maternal and child characteristics that may moderate or mediate the impact of disclosure. Finally, process evaluations for each intervention session as well as in-depth qualitative interviews with a subset of MLWHs who attended the intervention will provide information on issues that need to be addressed prior to a full-scale trial of the disclosure intervention.  Few interventions, other than for prevention or medication adherence, are available for women living with HIV; this study will evaluate an intervention that will help HIV-positive mothers deal with a serious family issue.

CLEAR Uganda; SUUBI Project

Choosing Life Empowerment Action Results is a behavioral change research project being implemented by Uganda Youth development Link (UYDEL) in collaboration with support from University of California, Los-Angeles. It is a result project known as CLEAR tried in the USA in the cities of Los Angeles and New York by the Center for Community Health (CHIPTS) to assist young people living with HIV/AIDS. Uganda and Kampala in particular, face increasing numbers of HIV/AIDS infections among young people living on the streets and slums. This project targets street and slum youth, 13-23 years living with HIV/AIDS in Rubaga and Kawempe Divisions of Kampala district.

Interventions, Training Manuals, etc. : 

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)

 

 

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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