Optimizing Access to nPEP for HIV Using Contingency Management in Stimulant-Using MSM

The majority of new HIV infections across Los Angeles County continue to be found among men who have sex with other men (MSM). Within MSM, stimulant abuse, particularly methamphetamine abuse, is the major factor in driving new infections, primarily via behavioral disinhibition contributing MSM methamphetamine users to engage in extremely high-risk sexual transmission behaviors. Friends Care combines the biomedical intervention of Post-exposure Prophylaxis (PEP) for HIV prevention with the behavioral intervention Contingency Management (CM), which targets reduction of methamphetamine use as a way of reducing concomitant high-risk sexual behaviors for HIV-negative, methamphetamine-using MSM.

Friends Care will enroll 49 HIV-negative, methamphetamine-using MSM into the CM component of the dual intervention. Participants receive a baseline assessment including urine analysis for the presence of methamphetamine metabolites, a rapid oral HIV antibody test, a physical examination including a comprehensive metabolic panel and complete blood count, HIV/STI prevention information, and medication adherence information. Following baseline assessments, participants begin an 8-week, 3x/week, CM intervention and are given a 4-day starter pack of tenofivir with emtricitabine (i.e., Truvada). Participants earn vouchers for methamphetamine metabolite-free urine samples, which are redeemable for goods and services.

In the event of an unexpected high-risk sexual exposure to HIV, i.e., unprotected anal intercourse with an HIV-positive or status unknown partner, participants are instructed to immediately call the clinic and begin the 4-dose starter pack of Truvada. An appointment with the physician is scheduled within 96 hours of the participant’s first dose of Truvada; participants then receive a second rapid oral HIV antibody test and are given the additional 24-day pack of Truvada.

Participants return to the clinic at 3-months post baseline for a follow-up evaluation and a third rapid oral HIV antibody test. In combining these two interventions in this unique program, Friends Care aims to reduce methamphetamine use and concomitant high-risk sexual behaviors, while reducing potential seroconversions.

China Provider Project

China has one-fifth of the world’s population (1.4 billion people); the risk of an HIV pandemic is substantial. In 2005, AIDS surpassed hepatitis B to become the third deadliest infectious disease in China in 2005. The Chinese government has implemented a national program, “Four Frees and One Care,” which mandates access to free HIV testing and free anti-retroviral (ARV) treatment to AIDS patients in China.

As the demand for HIV treatment and care increases rapidly, service providers in China are at a critical point with growing responsibilities to deliver adequate services and care for patients living with HIV/AIDS (PLH). However, experiences of unwelcoming treatment often discourage PLH from seeking care from providers who exhibit discriminatory attitudes and behaviors. HIV-related stigma has a tremendous impact on PLH’s health outcomes, health seeking behavior, and treatment adherence. Only when patients’ fears of discrimination are reduced will they be more willing to participate in HIV testing and treatment.

The National Institute of Mental Health funds this four-year randomized controlled trial that addresses both individual and structural components to reduce HIV-related stigma among service providers in China. This intervention trial builds on a three-year pilot study that we conducted among 1,344 service providers in China from 2003 to 2006. From the pilot, we recognized the need to address HIV-related stigma by building social norms of acceptance and focusing on the well-being of all patients as well as service providers. This Popular Opinion Leader [POL] and access to universal precautions intervention integrates the behavioral level with the structural level and incorporates all core elements of the POL model with four training sessions and bi-monthly reunion sessions. We plan to train 600 POL providers in 40 county hospitals in Yunnan and Fujian, China.

The intervention trial will proceed in two phases. In Phase 1, we will develop and finalize the intervention, assessment instruments and implementation procedures. In Phase 2, we will randomly assign 40 hospitals to either: 1) an intervention group, or 2) a standard care group. The impact of the proposed intervention will be assessed over 12 months (baseline, 6 & 12 months), with 1,760 service providers and 1,000 patients. The provider outcomes are providers’ attitude and behavior changes toward patients and their universal precaution practice. The patient outcomes are patients’ perceived stigma, medical service utilization, and satisfaction and treatment adherence.

Published Journal Articles :

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MD for Life: Making Decisions for Life

MD for Life is a study that will help health-care professionals and researchers learn how well an intervention works with people living with HIV. Funded by the University-wide AIDS Research Program, the intervention is designed to reduce sexual risk and substance behavior by increasing motivation and intention for behavior change among individuals living with HIV. The intervention will be delivered in two different modalities. The first intervention delivery strategy will have a health care professional, trained in counseling techniques, talk with patients about their sexual and substance use risk behaviors. The second delivery strategy will have the patient receive the counseling via an interactive and engaging computer program. The counseling is based on a proven technique called motivational interviewing. This counseling technique has been successful in reducing alcohol use in multiple populations. A total of 400 patients are being recruited from four health clinics (100 patients from each clinic) that primarily serve individuals living with HIV.

While other HIV prevention programs have been successful, they have been expensive, needed multiple small group sessions, and required coordination of many schedules and extensive training for staff. This project builds on previous prevention successes and utilizes existing staff, treatment delivery settings, and new technology to deliver a brief innovative intervention that can be repeatedly delivered to a diverse population of individuals living with HIV. If successful, this program would be an inexpensive and fairly effortless program to implement in health clinics nationwide.

Links to Interventions, Training Manuals, etc. : 

Please call us, 310-794-8278, regarding the computerized based intervention.

Healthy Living Project (HLP): Multi-Institutional Collaborative Research Project

The UCLA Healthy Living Project was funded by the National Institute of Mental Health (NIMH) and was designed to promote health-related behavior changes in adults living with HIV. This project aimed to reduce sexual and injection drug use risk behaviors among 1,200 HIV positive men and women in order to decrease the likelihood of secondary HIV transmission. The research study focused on four subgroups: women, heterosexual men, men who have sex with men, and injection drug users. The study was conducted at four sites: Los Angeles, Milwaukee, New York, and San Francisco.

Targeted Risk Group:

Adults living with HIV

Interventions, Training Manuals, etc. : 

Intervention model:

Cognitive behavioral intervention comprised of 15 individually delivered counseling sessions covering three areas: “Stress, Coping, and Adjustment,” “Risk Behaviors,” and “Health Behavior.”

Research Methods: 

In a random assignment study, individuals assigned to take part in the intervention were compared with individuals assigned to a control group, i.e. delayed intervention, on HIV-transmission behaviors, including unprotected sex and substance use. Because participants were followed over two years, longitudinal random effect regression models were used to test the efficacy of the intervention.

Local Significance: 

The intervention was demonstrated to reduce risky sexual behavior and substance use.
At the end of the study, the goal was to train service provider staff to deliver the intervention to their clients. By collaborating with service providers early on in the intervention study, it was possible to learn how to tailor the intervention to the specific needs of the agencies involved and the people they serve.

International Significance: 

HLP provided a behavioral intervention that can be adapted for other countries and cultures to reduce HIV-transmission risk behaviors

Project Tech Support

Interventions, Training Manuals, etc: 

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Out-of-treatment, methamphetamine-using men who have sex with men (MSM) are at extreme risk of HIV acquisition and transmission, predominantly through high-risk sexual behaviors that are facilitated by use of the drug. Project Tech Support study enrolls 50 out-of-treatment, methamphetamine-using MSM into an information technology (IT) communication intervention. Field workers conduct outreach in identified venues in the natural settings where out-of-treatment, methamphetamine-using MSM congregate. Over the course of two weeks, participants engage in a text messaging intervention and receive real-time HIV prevention messages, social support and referrals for healthier, prosocial choices regarding drug- and sexual-risk behaviors.

The study aims to:

(1) conduct formative work to assist in the development of an IT communication intervention for reducing methamphetamine use and high-risk sexual behaviors among out-of-treatment MSM;

(2) assess the feasibility and utility of the behavioral intervention on the target population; and

(3) gather indicators of the mechanism of action for this intervention, a dose-response association will be evaluated between the extent of use of IT communication system and the degree of reduction in methamphetamine use and concomitant sexual risk behaviors.

Evaluations, including biological markers for drug use and HIV serostatus are collected at baseline and two months post-intervention.  Cognitive and behavioral outcomes are measured. Findings from this study will inform the field on the feasibility of adapting an IT communication intervention for reducing sexual risk behaviors and HIV acquisition and transmission among out-of-treatment, methamphetamine-using MSM.

 

Voucher-based Incentives in a Prevention Setting (VIPS)

Interventions, Training Manuals, etc. : 

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Homelessness is a significant problem plaguing American cities and homeless substance abusers face increased risks. Homeless, gay and bisexual male abusers suffer approximately 80% seroprevalence and often engage in exchange sex and resist treatment for substance abuse. Contingency management interventions, which provide positive incentives for behavior change, may be particularly well suited for this disenfranchised, high-risk cohort. Specifically, voucher-based incentive therapies may be effective since they have established potency for increasing prosocial behaviors that successfully compete with taking drugs and for reducing drug use.

A randomized, controlled trial assigns 131 non-treatment seeking gay, bisexual or MSM substance users to either voucher-based incentive therapy or control groups for 24 weeks, with follow-up evaluations at 7, 9 and 12 months post randomization. The voucher-based group earns vouchers in exchange for completing prosocial and healthy behaviors, and/or submitting drug-negative urine and alcohol-negative breath samples, and/or attendance in a standard HIV prevention program, OAPP-funded The G.U.Y.S. Program. The control group receives feedback regarding behaviors performed and urinalysis and breathe alcohol tests, but does not receive voucher points for these behaviors, but does receive vouchers for attendance in a standard HIV prevention program, The G.U.Y.S. Program. Vouchers are redeemable for goods located in an onsite voucher store or purchased for the participant.

The study will assess the efficacy of the voucher-based intervention for increasing prosocial and healthy behavior and reducing substance abuse among these non-treatment seeking gay, bisexual and MSM substance users receiving standard HIV prevention services. The study will also assess the impact of the voucher-based incentive therapy on other measures of therapeutic change consistent with a harm reduction approach, including reduction of psychiatric symptoms, decreased injection drug use and high-risk sexual behavior, increased participation in The G.U.Y.S. Program, and improvement in different domains of overall functioning (medical/social/vocational).  Additionally, the study will examine whether baseline participant characteristics predict voucher-based outcomes.

Applying voucher-based incentive therapy to non-treatment seeking gay, bisexual and MSM substance users as well as integrating the intervention into a county-funded HIV prevention program with a harm reduction philosophy are both highly innovative. The VIPS study has the potential to have a significant impact on the public health of the Los Angeles homeless, gay and bisexual substance-using community. If voucher-based incentive therapy is efficacious for motivating non-treatment seeking gay, bisexual and MSM substance users in a community-based HIV prevention program to increase prosocial and healthy behaviors and decrease drug/alcohol use, established prevention programs may modify their approaches to include contingency management, and use it to address the staggering public health problems non-treatment seeking homeless substance users face on a daily basis.

 

Philani- Cape Town

There are four intersecting epidemics among pregnant women in South Africa: hazardous alcohol use (30%), HIV (27%), TB (60% of HIV+), img_5313and 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. Furthermore, while clinics are the typical sites for treating each of these health problems, the NIAAA-funded Philani study is examining a home-visiting prevention program delivered by neighborhood Mentor Mothers (MM) as an alternative to clinic-based interventions 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 the 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: 

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Surveys/Scales Used: 
  1. Tolerance, Worried, Eye-Opener, Amnesia, Cut Down (TWEAK) - Survey
  2. Social Support - Survey
  3. Romantic Relationships - Survey
  4. Reproductive Health - Survey
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  6. Routines
  7. Relationships and Violence - Survey
  8. Household Characteristics and Composition - Survey
  9. AIDS Knowledge and Attitude for Pregnant Women - Survey
  10. Edinburgh Postnatal Depression Score (EPDS)
  11. Alcohol Use Disorders Identification Test (Audit C) - Scale
  12. Feeding Strategies to Prevent Transmission - Survey
  13. Medication Adherence - Survey
  14. Employment and Labor Experience Assessment - Survey
  15. CDC Sexual Behavior Questions (CSBQ)
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  17. Alcohol and Other Drug Abuse (AOD) - Scale
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  19. HIV Testing Assessment - Survey
  20. General Medical History Assessment
  21. General Health Questionnaire

Intervention model:
Mothers who are thriving in the community are chosen to act as role models, i.e. mentor mothers, for mothers at risk in the same community. This is based on the positive peer deviant model. Mentor mothers conduct home visits during the course of the study.

Research Methods:
Twenty four neighborhoods were randomly assigned to the intervention (12 neighborhoods), i.e. a mentor mother home visiting program, or control condition (12 neighborhoods). There are two levels of nesting in the study. Mothers and their infants are nested within neighborhoods, 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. Preliminary results are promising and suggest the mentor mother program may be an efficient mechanism to conduct healthcare-related home visits.

International Significance:
If found to be efficacious, the home-visiting model that relies on paraprofessionals, i.e. trained mentor mothers, offers a viable alternative to clinic-based healthcare and or care that requires professional healthcare providers that may not be practical in poorer countries outside the U.S.

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.

Guys Understanding Your Situation (G.U.Y.S. Program)

Interventions, Training Manuals, etc. : 

The G.U.Y.S. Program offers a multi-tier health education/risk reduction (HE/RR) intervention – utilizing both individual and group-level interventions – designed to reduce high-risk sexual and drug behaviors among homeless, substance-using gay men and non-gay identified men who have sex with other men, and with women, and with transgender women. Most specifically the intervention targets sexual risk behaviors that are most likely to occur while using methamphetamine, particularly unprotected anal intercourse, as well as exchange sex risks and injection drug risks.

The program consists of a comprehensive, culturally appropriate, continuum of services that includes outreach, individual-level interventions (ILI), skills building group-level interventions (GLI) and art support GLIs. Follow-up ILI assessments are conducted at 30, 60 and 90 days. Face-to-face street outreach is conducted in identified high-risk areas of Hollywood and West Hollywood and in the natural settings where homeless, substance-using men congregate. The program has successfully worked with these populations in highly charged sexual arenas and developed non-invasive outreach and intervention strategies for these venues, which vary based on the safety and atmosphere of each public or commercial sex environment. The skills building GLI component of the intervention serves to increase knowledge and awareness of HIV risk behaviors and develop skills to decrease HIV risk behaviors. Concurrently, the art support GLI component of the intervention serves to increase social support and self-esteem. Art is used as a harm reduction strategy by offering an opportunity for participants to closely identify their feelings and work towards understanding many of their high-risk behaviors. The art support GLI provides a space to cultivate their voice and express their experiences through art. Both the skills building GLI and art support GLI – working concomitantly with the outreach encounters and ILI – motivate ongoing and maintained HIV risk reductions and gear participants’ towards HIV testing to identify their HIV status and, finally, develop skills for disclosing HIV status.

 

Street Smart Uganda; UYDEL

Targeted Risk Group: 

Urban Ugandan youth (UYDEL)

Street Smart was an intensive HIV/AIDS program for slum youths whose behaviors place them at risk of becoming HIV infected. It was implemented in collaboration with Uganda Youth Development Link.

Based on the fact that adolescence is a time of experimentation and developmental change in behavior, thoughts and emotions, Street Smart linked feelings, thoughts, emotions and attitudes to behavior change.

In 2007, nearly 1 million young people became infected with HIV in sub-Saharan Africa. Existing prevention programs have not been effective, prompting more attention toward the social determinants of HIV, such as unemployment. Without hope for the future, it is unlikely that young people will be motivated to remain free of HIV, as poverty creates vulnerability to survival sex or sex without condoms. The Street Smart intervention was developed in the United States to eliminate or reduce HIV risk behaviors among young people. Despite its success, it does not address the problems of economic vulnerability and investment in the future. The aim of this study was to test the added value of vocational training provided to urban Ugandan youth, in addition to the Street Smart HIV prevention program.

Download the UYDEL 2010 brochure here:  Uganda Youth Development Link (UYDEL) (2010) - Brochure

Interventions, Training Manuals, etc. : 

  1. Street Smart Introduction
  2. Street Smart Session 1: Language of HIV and STDs
  3. Street Smart Session 2: Personalized Risk
  4. Street Smart Session 3: How to Use Condoms
  5. Street Smart Session 4: Drugs and Alcohol
  6. Street Smart Session 5: Recognizing and Coping with Feelings
  7. Street Smart Session 6: Negotiating Effectively
  8. Street Smart Session 7: Self Talk
  9. Street Smart Session 8: Safer Sex
  10. Street Smart Session 9: Personal Counseling
  11. Street Smart: Table of Contents - Sessions 1-10

Intervention model: 

Street Smart consists of a total of 10 sessions (eight two- hour group sessions, one individual session and a group visits to a community health resource), exposes youth to information regarding HIV/AIDS, drug abuse, condom use, personalized risks, negotiating safer sex, recognizing and coping with feelings and self talk. Intervention sessions included participatory discussions, role-plays & use of tokens. Participants were divided into groups consisting of 8 to 9 members per group. Each group attended 3 sessions a week, each session lasting an average of 2hrs and 30 minutes.

Research Methods:

The project included a total of 50 street and slum youth from two slum centers in Kampala. Participants completed a behavioral assessment at baseline and at 4-months. Twenty-five participants from one slum center initially served as the control group and received the intervention after their 4-month follow-up assessment. Twenty-five participants from the second slum center received the 10-session HIV prevention intervention immediately following their Baseline assessment.

Local Significance: 

A total of 24 participants (96%) completed the entire 10 session intervention. The youth were also linked to important support services available to them. Given the small sample size and limited statistical power, longitudinal hierarchical linear models to examine the efficacy of the intervention were not appropriate. However, feedback gathered from both the youth participants and research staff, the intervention was very well-received. The youth’s engagement in the intervention is also apparent in the extremely high completion rate of the intervention.

International Significance: 

There were two primary objectives to the collaboration with Uganda Youth Development. The first objective was to build the research capacity and skills among the team of Uganda collaborators. During the course of the project, the UCLA team conducted non-formal and formal training activities in Uganda. The second objective was to adapt, implement, and evaluate the efficacy of the adapted HIV prevention intervention with street and slum urban youth in Kampala, Uganda. This was accomplished through the collaborative effort of the UCLA researchers and the Uganda research team.

The Street Smart intervention continues to be implemented by the staff at UYDEL, demonstrating the staff support and commitment to the intervention and the work completed through the research. Mr. Rogers Kasirye has consulted with other Ugandan agencies regarding the development of interventions and research with street and slum youth in Uganda.

Despite some study limitations, the results suggest that at 4 months the vocational training program improved employment, satisfaction with life, and social support; and reduced delinquent behaviors. Vocational training plus Street Smart improved social support and reduced sexual risk-taking, delinquent behavior, and substance use at 2 years. Fewer than half had ever worked prior to the program, but over 80% were employed at 2 years. Larger trials of HIV interventions addressing social determinants are warranted.