Posts classified under: HIV -

Friends Care I

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.

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P-QUAD Study

PQUAD is a pilot project to evaluate the acceptability, safety, and feasibility of delivering community-based HIV post-exposure prophylaxis in diverse Los Angeles County communities. It is a joint venture of UCLA, the Los Angeles Office of AIDS Programs and Policy (OAPP), the Department of Public Health Sexually Transmitted Disease Program, AIDS Project Los Angeles (APLA), and pharmaceutical industry partners.

Originally conceived in December, 2007, P-QUAD is now operational at 2 sites in epicenters of the HIV epidemic in Los Angeles: The Los Angeles Gay and Lesbian Center (opened March 2, 2010 in the Hollywood/West Hollywood area of Los Angeles with a largely MSM catchment), and The OASIS Clinic (opened April 15, 2010 in the south central area of Los Angeles with a largely lower socioeconomic status, at risk African-American and Latino catchment). The study provides dual or triple-agent ART for 28 days as post-exposure prophylaxis for HIV infection to individuals exposed sexually or via injection-drug works sharing, when presenting within 72 hours of an appropriately high-risk exposure. Additionally, substance use, mental health, and behavioral risk reduction referrals/linkages are provided as appropriate. Efficacy, safety, adherence, tolerability and behavioral outcomes are being collected. In the event of seroconversions, longitudinal specimens are stored for virologic analyses.

The program currently is providing Truvada (tenofovir + emtricitabine), or Combivir (zidovudine + lamivudine) with or without Kaletra (ritonavir + lopinavir). An upcoming amendment will offer Isentress (raltegravir) as an alternative to Kaletra for intolerance. An IND has been filed with the FDA for the use of these agents in a non-FDA approved study context (IND # 104,989) and the study is overseen and all study documents approved by the UCLA Institutional Review Board. Since opening the program, the P-QUAD has enrolled 30 participants as of May 6, 2010 [29 at LAGLC and 1 at OASIS], with an initially planned enrollment of 100 participants (50 at each site).

Feasibility Study of a Community Level, Multi-Component, Intervention for Black MSM

To ascertain the feasibility and acceptability of an intervention among Black men who have sex with men (MSM), to prepare for a community-level randomized trial to test the efficacy of the intervention in reducing HIV incidence among Black MSM.

Approximately 2136 “first wave” participants (267 per site at eight sites) and approximately 400 referred partners (70 per site at six sites). There will be no limit on enrollment of participants referred by “index” participants already in the study (according to the referring scheme in the protocol). Index participants are defined later in the protocol, but can be generally described as those newly identified with HIV infection, those with previously diagnosed HIV infection who are not receiving HIV care, and certain HIV negative participants. Men enrolling for this study who have not been referred by an index participant will be called “first wave” participants. Enrollment of first wave participants will cease when 200 first wave participants eligible for longitudinal follow up have been enrolled. Enrollment of certain sub-categories of first wave participants will be limited according to criteria detailed in the protocol.

Treatment Regimen:

The intervention components provided to participants include: HIV risk-reduction counseling, testing and referral for care STI testing and referral for care Screening for substance use and mental health issues, and provision of counseling and referral for care (if indicated) Engagement with peer-health navigators to facilitate uptake of healthcare and other services Enumeration of up to 20 social and sexual network members by all participants and referral of up to 5 sexual partners by index participants for enrollment into the study

Primary Objectives:

To obtain information needed to design the full community-randomized trial, particularly in the areas of: recruitment of black MSM satisfaction of Black MSM with intervention components uptake of the intervention components by Black MSM, including: Proportion of enrolled participants who agree to HIV testing Proportion of participants who agree to STI testing Proportion of participants who utilize peer navigator referrals Proportion of HIV infected participants entering HIV care Increase in condom use in all participants from enrollment to week 52 Decrease in viral load among HIV infected participants from initiation of HAART to week 52 Decrease in STIs among all participants from enrollment to week 52

Secondary Objectives:

To collect samples, behavioral data and HIV test results to improve laboratory measures of HIV incidence based on samples derived from cross-sectional studies To estimate the HIV incidence rate and the effect of the intervention on the incidence rate through mathematical modeling To describe characteristics of sexual network members of black MSM who are newly diagnosed with HIV infection, or previously diagnosed but not in care To assess attitudes of black MSM toward other prevention interventions To describe social and sexual networks of Black MSM within cities to inform decisions about what constitutes a randomizable unit for a future trial of the intervention.

Study Sites:
• Atlanta: Emory University
• Boston: Fenway Community Health Center
• Los Angeles: University of California Los Angeles
• New York City: New York Blood Center/Harlem Hospital
• San Francisco: San Francisco Department of Public Health
• Washington DC: George Washington University

Interventions, Training Manuals, etc. :
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Community Health Study

There have been few attempts to monitor the risk behaviors and HIV seroprevalence among the general population.

Understanding the HIV epidemic in Los Angeles requires establishing an integrated, multilevel surveillance system for HIV, sexually transmitted diseases (STDs), and the Hepatitis C virus (HCV). Information about sexual and substance use risk behaviors, HIV seroprevalence, and public knowledge, attitudes, and norms regarding HIV are needed for public health planning. A surveillance system will be required in order for Los Angeles to maintain funding for Ryan White and other federal and state funding sources. To begin to develop a method for mounting a comprehensive surveillance system, the City of Los Angeles is planning a study examining the acceptability of anonymous HIV testing and volunteering information about one’s risk behaviors in order to allow planning for HIV-related services.

Most studies of HIV seroprevalence and risk behaviors have been conducted with subgroups identified at high risk for HIV: young gay men, injecting drug users, homeless adolescents, or seriously mentally ill adults. There have been few attempts to monitor the risk behaviors and HIV seroprevalence among the general population (not necessarily from identified high-risk groups). Before any comprehensive surveillance system can be established, the ability to monitor HIV in community settings and among households in neighborhoods with high rates of AIDS cases must be established. To fill this gap, a two-phase project is being initiated by the city in order to assess the acceptability of HIV testing and reporting one’s risk behaviors when approached: 1) in a household survey; or 2) in a neighborhood setting such as a shopping mall, grocery center, theater, or church.

First, the acceptability of gathering HIV-related information from a household will be examined by conducting a supplement to the Los Angeles Health Survey that will be mounted this summer. An anonymous telephone interview will be conducted with random digit dialing of households within the City of Los Angeles. Randomly selected telephone numbers (n=100) will be surveyed on knowledge of transmission of HIV, attitudes and norms towards members of high-risk groups (e.g., gay men) and infected persons, and willingness to anonymously be tested for HIV. All responses will be recorded unlinked from telephone numbers selected by random digit dialing; therefore the identify of all respondents will be unknown and can never be traced. From gathering this information, the acceptability of a household approach as a method of gathering information about HIV-related information will be assessed.

Second, a community with a high rate of AIDS cases will be selected. In this neighborhood, local leaders will be consulted to identify a strategy for sampling community members anonymously and in settings accessible to all community members. In shopping malls in both communities, adults will be asked to anonymously volunteer to participate in a survey of attitudes and norms regarding HIV prevention activities, recent sexual and substance use risks acts, and consent to a saliva-based HIV test. The results of any individual test results will not be available; unmarked samples will be collected in order to indicate a community seroprevalence rate. Interested individuals will be offered an incentive for participating in the survey and test. The willingness of adult members of the community to participate in a study anonymously will be evaluated. Similar to the telephone household survey, no identity of any participant will be obtained. Overall, community rates will be obtained, but no individual information regarding risk or infection status.

The results of these two activities will be used to inform the Los Angeles County Board of Supervisor’s decisions regarding the best method for establishing surveillance methods for HIV infection and predictions regarding the future routes and subgroups for HIV infection. Currently, the County is considering adopting a method of practitioners informing public health officials of all persons testing seropositive for HIV or for a system of unique identifiers for persons who test seropositive for HIV. Both of these systems rely on the identification of seropositive persons, an event that typically occurs about 10 years after a person has become infected. Alternative strategies for monitoring the epidemic, especially among communities with an emerging epidemic must be identified. These studies will inform the strategy selected by the County and may become a national model.

Angola – Acceptability of Handheld Computers to Collect Self-reported Sexual Behavior Data in Angola

Acceptability of Handheld Computers to Collect Self-reported Sexual Behavior Data in Angola

This study evaluates the cultural acceptability and cost-effectiveness of using handheld computers to collect sexual behavior data, in order to reduce disparities in access to HIV/AIDS prevention and care services in Angola, a country severely impacted by HIV/AIDS. Specifically, this study aimed 1) to assess how comfortable Angolans feel in disclosing sexual behavior in handheld computer surveys compared to paper surveys, and 2) to assess how comfortable Angolan interviewers feel in administering handheld computer surveys vs. paper surveys.

Targeted Risk Group: 

Sexually active adults, 18-45

Intervention model: 

Randomized Control Trial

Research Methods: 

We conducted an experiment in three neighborhoods of Luanda, Angola to assess the impact of the technology on people’s comfort and willingness to disclose sensitive personal information, such as sexual behavior. Participants were asked about their HIV/AIDS-related knowledge, attitudes, and practices by local interviewers using either handheld computers or paper surveys. T-tests showed no differences between participants’ self-reported comfort across handheld and paper conditions. However, participants in the handheld condition were more likely to give socially desirable responses to the sexual behavior questions than participants in the paper condition.

International Significance: 

Handheld computers have potential to improve HIV/AIDS programs in healthcare settings in low-income countries, by improving the speed and accuracy of collecting data. However, the acceptability of the technology (i.e., user attitude and reaction) is critical for its successful implementation. Acceptability is particularly critical for HIV/AIDS behavioral data, as it depends on respondents giving accurate information about a highly sensitive topic – sexual behavior. These results suggest that using handheld computers in data collection in Angola may lead to biased reports of HIV/AIDS-related risk behaviors.

¡Tu Vales!: An HIV Testing Campaign for Latino Day Laborers

Project Name: 

¡Tu Vales!:  An HIV Testing Campaign for Latino Day Laborers

Some Latino men involved in high risk behaviors have been found to be more likely to choose to get tested for HIV when the HIV test is “bundled” with other tests.

A recent study of Latino male immigrant day labors in Los Angeles County found that engaging in risk behaviors, such as having sex with men, was not associated with HIV testing. Thus some day laborers at high risk may not be accessing HIV testing services. However, increasing HIV testing among Latino day laborers may not solely be a function of offering the HIV test to them. Unique ways of offering HIV testing may be required in order to increase HIV testing. Some Latino men involved in high risk behaviors have been found to be more likely to choose to get tested for HIV when the HIV test is “bundled” with other tests compared to when it is offered by itself. The objective of this study is to increase HIV testing among day laborers at risk for HIV. The specific aims of this study are:

(1) to determine if a “bundled” HIV testing protocol directed at day laborers results in more immigrants accessing HIV testing compared to an HIV-only testing protocol., and

(2) to determine if a “bundled” HIV testing protocol results in more men engaging in HIV prevention services among those involved in high-risk activities compared to when an HIV-only testing protocol is used.

The “bundled” HIV testing protocol will include tests or screeners for syphilis, gonorrhea, chlamydia, alcohol problems, drug dependence, depression and HIV. Individuals in the HIV-bundled protocol will be able to choose to be tested for all conditions or just some of them.

Targeted Risk Group: 

Latino day laborers engaged in high-risk activities

Research Methods: 

In contrast to previous studies with day laborers, this study will involve a random recruitment of day laborers using a spatial-temporal sampling frame. Two HIV testing protocols, one “bundled” and the other “HIV-only,” will be carried out at day labor sites in Los Angeles County. In the formative stage of our project, we plan to determine which day labor sites contain the largest number of day laborers reporting high-risk activities. We will use the Service Planning Areas (SPAs) of Los Angeles County. We will utilize SPAs 4, 6, 7 and 8. By doing so, we will be focusing on the areas in which 73.9% of all male Latino HIV/AIDS cases were identified between 2004 and 2007. Once all day labor sites in these SPAs are identified, we will visit them at randomly selected times and randomly sample 15% of the individuals who are present when we arrive. These participants will be administered a short screener to assess HIV-related high-risk behaviors. After determining which sites contain the largest number of day laborers reporting high-risk activities, we will develop a sampling unit of “site-day-shift,” where “site” refers to the day labor site, “day” to the day of the week, and “shift” to a 5-hour time period within the day. The sampling plan for the study recruitment for the main part of the study will involve 4 stages: the random assignment of the 4 SPAs to either the HIV-only protocol or the HIV-bundled protocol, the monthly random selection of the day labor sites, the monthly random selection of the sampling units and the random selection of participants at the day labor sites.

A total of 800 participants will be recruited, with one-half being recruited through the HIV-testing only protocol and the other half through the HIV-bundled protocol. Tallies will be kept of the number of people who are approached and asked to participate for each testing protocol and those who accept and decline HIV testing. Rates of HIV testing for the two HIV testing protocols will then be compared.

This study is interested also in which protocol results in greater engagement in HIV prevention services among those reporting high-risk activities. Those reporting HIV-related high risk behaviors will be contacted 2 months later for a brief phone interview to determine if they subsequently utilized the referrals to HIV prevention programs. The two HIV testing protocols will then be compared to determine which resulted in a greater use of HIV prevention services by day laborers.

Local significance:

Information on potential increased HIV testing by day laborers using a “bundled” testing protocol would contribute to advancing HIV prevention science and also provide important information for prevention programs throughout California. Thus, this project is very attentive to the needs of public health and community based organizations in California attempting to counter the present trend of late testing among Latinos.

Feasibility and Acceptability of PrEP and Non-occupational Npep for HIV Prevention in Los Angeles

This is a qualitative study of knowledge, attitudes, beliefs, and perceived barriers to implementation of biomedical prevention strategies among MSM in metropolitan Los Angeles, California. Three focus groups comprised of sixteen unique individual participants were conducted at the UCLA Center for Clinical AIDS Research and Education between April 2008 and June 2008. Additionally, five key informants were interviewed individually. Three interviews were performed face-to-face, and two were performed via telephone for participant convenience.

MSM in metropolitan Los Angeles were recruited via Craigslist (www.craigslist.com), newspaper/magazine advertising, and palm-card and flyer distribution at MSM-focused locations including bars, restaurants, dance clubs, and commercial sex venues. Twenty men responded to advertising and were scheduled for three focus group dates; 16 men presented for focus group participation. Key Informants were recruited on a first-responder basis from a master list of HIV providers and community based organization staff and activists who attend UCLA HIV-related symposia and events. Each participant (focus group and key informant) was compensated $20 for their time.

Interventions, Training Manuals, etc. :

Feasibility and Acceptability of PrEP and Non-occupational PEP for HIV Prevention - Final Study Report

Hep-Safe Hollywood

Homeless, stimulant-using gay/bisexual men and transgender women are at high risk for hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV infection due to high rates of injection drug use and high-risk sexual behaviors. Thus, use of stimulants threatens to intensify homeless persons’ risk of exposure to hepatitis B, C viruses and HIV; therefore, research focused on this group is critical. A contingency management (CM) intervention may be particularly well suited for this high-risk population. CM is an intervention that attempts to modify a targeted behavior by providing incentives for changing that behavior (in simple terms, positive reinforcement). CM interventions have been successfully implemented among stimulant-using gay and bisexual men to reduce drug use and concomitant sexual risk behaviors.

The Hep-Safe Hollywood study will implement a CM intervention to increase successful HAV/HBV vaccination completion programs among homeless, stimulant-using gay/bisexual men and transgender in Hollywood. This randomized, control trial will assign 500 homeless, stimulant-using gay and bisexual men to either an enhanced nurse case managed program, which includes specialized education and CM, or a standard program, which includes brief education and CM. This study is innovative in that it will allow us to look at the effect of an enhanced nurse case management and CM program versus a standard brief education and CM program. The study will evaluate the effectiveness of homeless, stimulant-using gay/bisexual men and transgender women on completion of the HAV/HBV vaccine and, secondarily, on reduction of risk for hepatitis and HIV. Additionally, the study will assess the relative cost of these programs in terms of completion of the vaccine series. The study combines best strategies to approach, engage and intervene with this hidden and high-risk population and to assess the feasibility and efficacy of interventions that may prove beneficial in preventing hepatitis A, B, C and HIV infections.

This study is a collaboration between UCLA School of Nursing and Friends Research Institute, with Dr. Adeline Nyamathi, as the principal investigator.

 

HIV Prevention Capacity Building Assistance and Technical Assistance for Community-Based Organizations and Health Departments

This CDC-funded project is a collaboration between AIDS Project Los Angeles (APLA) and CHIPTS aimed to deliver capacity building assistance (CBA) services to community based organizations (CBOs) and health departments in the areas of (1) organizational infrastructure and program sustainability, (2) evidence based interventions and public health strategies, and (3) monitoring and evaluation.

The project will provide a wide range of CBA services to CBOs, including individually-tailored CBA (ICBA) services to address specific HIV prevention programmatic needs for organizations serving racial and ethnic minority communities and other high risk populations. The project will conduct an individual CBA needs assessment as the foundation of ICBA services, through which we will jointly develop an action plan with the CBO to address identified needs.

ICBA services may include: individualized technical assistance and consultation; skills building trainings (both inperson and web-based formats); web seminars; information transfer and technology transfer through the broad dissemination of technical information; participation in an online discussion forum to promote peer-to-peer sharing of best practices; and promotion of program collaboration and service integration across public health initiatives. In addition, the project will implement similar CBA services to health departments as it does to CBOs. However, we will tailor information and materials, skills building trainings, web seminars, etc. to address the unique needs and problems of health departments. The project will also work closely with health departments to provide training in the evaluation of community planning methodologies. We also propose to collaborate with other CBA providers to develop a Professional Development Certificate Program for health department staff, ensuring a basic level of knowledge across all four component areas.

For more information, please visit the Shared Action website at www.sharedaction.org.

Popular Opinion Leader HIV Intervention among Chinese Market Workers

This project is part of the NIMH Collaborative HIV/STD Prevention Trial which adopts a two-arm, randomized community-level design to test the Popular Opinion Leader (POL) HIV prevention intervention model at five international sites (China, India, Peru, Russia, and Zimbabwe). CCH is the lead on the China site.

China, representing 1/4th of the world’s population, has a rapidly emerging HIV epidemic with about 1.2 million individuals already infected, more than the total of all the Asian nations combined. Similar to Africa and India, the country’s 200-250 million labor migrants are a key to the epidemic’s future; however, HIV infection is predominantly occurring in rural settings (75% of population) and migrants transmit the virus heterosexually when moving to the cities annually.

The goals of this project are: 1) to adapt a comprehensive community-level preventive intervention – The Popular Opinion Leader – to populations in China based on data from ethnographic studies and compare the results with the other four international sites which follow the same research procedure; 2) to test the efficacy of this community-level preventive intervention in China as well as the four international sites utilizing both behavioral and biological outcomes; and, 3) to develop a manual that will permit different health care agencies and service providers to conduct rapid ethnographic studies, translate this community-level intervention to different settings and populations, and assess intervention efficacy.

The ability of CCH investigators to successfully implement the project is based on previous successful HIV prevention trials including interventions in China and participation in HIV-related cooperative agreements; support of the project from experienced Chinese collaborators, officials, and organizations; access to sites in China; collaboration with experienced Chinese investigators, several of whom have trained at UCLA; collaboration of the Qualitative Core of the UCLA-NPI with considerable cross-national and cross-site experience; and previous experience in conducting interventions and assessments that are culturally sensitive and appropriate.

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