Department of Psychiatry
Penn Behavioral Health

HIV/AIDS Prevention Research Division

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Previous and Closed Studies - Division Trials





Risk Assessment Project

The RAP study began with Center pilot funds in 1988 and received an RO1 in 1989. The objectives during this initial funding period were to examine the prevalence and incidence of HIV infection among in treatment (IT) and out of treatment (OT) injection drug users (IDUs) in Philadelphia.

This initial cohort included 31 infected and 224 uninfected subjects who were recruited at our field office located in North Philadelphia and followed at six-month intervals. At each assessment, participants completed an extensive behavioral assessment and were tested for HIV infection. After three years, this first cohort demonstrated overall HIV incidence rates of over 3% per year.

Among those recruited while out-of-treatment, the incidence rates were significantly higher, over 5% per year (Metzger, Woody et al, 1993; Metzger, Navaline et al, 1998). Studies were also conducted to explore the prevalence of sexual risk behaviors (Watkins, Metzger et al, 1992; Watkins, Metzger et al, 1993), the risk profiles of female IDUs (Cohen et al, 1995), feasibility of assessing risk behaviors via computer-assisted self interview (Navaline et al, 1995) and the social networks of IDUs (Frey et al, 1995).

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HIV Prevention Trials Unit

In July of 2000, the AIDS Research division was awarded a five-year cooperative agreement to be a site in the newly organized HIV Prevention Trials Network (HPTN). This Network is funded by NIH Institutes (e.g. NIDA, NIMH, NICHD, and NIAID) and awarded through NIAID. The mission of the HPTN is to test biomedical and behavioral HIV prevention interventions, using seroincidence as the endpoint.

Studies are developed in six science working groups-Perinatal; Behavioral; Substance Use; Microbicides; Antiretroviral Therapy; and STD. Dr. Metzger, as chair of the Substance Use Science Direction Group,has facilitated the development of two approved concept plans to evaluate the efficacy of social network interventions with IDUs in Thailand, Philadelphia, and New York. Additionally, a concept plan is being developed to test the efficacy of buprenorphine and naloxone in reducing incidence of HIV infection among heroin injectors in China.

The Philadelphia HPTU is continuing to play an active role in microbicide development and is slated to conduct two Phase I microbicide trials in the upcoming year. With the involvement of Dr. John Jemmott, a HPTN Co-Investigator from Penn's Annenberg School, our site is also taking the lead in developing a behavioral intervention protocol for adolescents in South Africa.

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VPS I: Vaccine Preparedness Study I

A vaccine preparedness study (VPS I) was initiated to examine the incidence of HIV infection among women at heterosexual risk and to expand the number of high risk IDU participants.

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VPS II: Vaccine Preparedness Study II

In 1998, a second vaccine preparedness study (VPS II) was initiated to examine the incidence of HIV infection among women at heterosexual risk and to expand the number of high risk IDU participants.

Our site recruited 222 women at high risk of infection due to heterosexual activity associated with their non-injection drug use (crack cocaine). At the close of the study, after 12 months of follow-up, HIV incidence was 2.04 per 100 person years and retention was 93%.

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High Risk IDU

The purpose of this study is to enroll a cohort of injection drug users who are considered to be at highest risk of HIV infection from the use of contaminated syringes and paraphernalia. It is desirable to include IDUs in future domestic vaccine trails for at least two reasons: first, to determine the efficacy of vaccines among persons whose risk of HIV infection is solely or primarily parenteral; and second, a large portion of the HIV/AIDS epidemic is now occurring among drug injectors and their sexual partners, and these groups account for much of the burden of HIV/AIDS among minority populations.

Many injection drug users, particularly women IDUs, may be dually at risk for HIV infection through needle use and through sexual exposure. However, this proposed recruitment is intended to focus on individual who are primarily at risk through needle use. Admittedly, it is difficult to isolate this risk factor entirely. However, risk behavior data will be collected during regularly scheduled VPS interviews with study participants. To the extent possible, these interview data will be used to associate seroincidence with particular risk behaviors.

The recruitment proposed here will focus on IDUs who are less likely to be practicing prevention strategies. Recent literature and unpublished data indicate that these higher risk individuals are mot likely to be found among younger injectors and IDUs being released from detoxification.

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HIVNET 014: Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox Vaccine

To expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine strategies: canarypox vector vCP205, or vCP205 with SF-2 rgp120. [AS PER AMENDMENT 7/2/98: To obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing antibody response to primary isolates of HIV-1 in the context of previous immunization with a canarypox vector expressing HIV antigens (vCP205). To evaluate cytotoxic T lymphocyte responses at 1 and 2 years after initial vaccination with vCP205 plus rgp120 SF-2 or vCP205 alone.] In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies that neutralize homologous laboratory strains; over 50% of patients have developed CD8+ cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential large-scale trials. [AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.]

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BestBET: Empowering Women Drug Users to Reduce HIV Risk

Available epidemiologic data suggest that female drug users are at the highest risk of HIV infection, relative to other risk groups in the US. The proposed project, BestBET, addresses core features of a female drug user's HIV risk--- economic and emotional dependence on an often-risky sex partner. The intervention uses a woman-specific prevention approach, already tested for feasibility and short-term behavior change on diverse cultural groups (Gollub, French et al, 2000).

Based on Body Empowerment Theory, BestBET provides interactive, skills-based learning, and offers a range of new protection technologies to women, including the female condom. Group intervention sessions, led by trained "near-peer" counselors, will focus on risk-reduction for sexual and drug-related HIV risk, and on combined drug-sex risk behavior. This 3-year, randomized controlled trial will recruit 240 out-of-treatment drug-using women in West Philadelphia. Both arms will first receive an enhanced HIV CT module composed of 2 short individualized counseling sessions.

The study will test the effects of adding a multiple-group session model administered over 5 weeks, with 2 boosters, against a control condition receiving only the CT module. Follow-up assessments for behavioral (via Audio- CASI) and biological/serological outcomes (incidence of gonorrhea, chlamydia, trichomonas, HIV and syphilis) will occur at 6-month intervals over 12 months. Treatment of incident infections will provide valid measures of STD incidence. A strong relationship with community organizations will be sought, including: community input into the study throughout, training of community group leaders in study techniques and technologies, the distribution of women's "sexual risk reduction kits", and adoption of study activities by community groups by the time of study termination.

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CCT: Comparison of Consumer-Controlled Testing and Traditional HIV Counseling and Testing

Recent advances in early retroviral therapy and the availability of antibiotic prophylaxis for opportunistic infections, combined with the opportunity to prevent perinatal HIV infection, underscores the value of early diagnosis of HIV infection. The recent licensing of HIV antibody home test kits (consumer-controlled testing, CCT) now offers individuals the opportunity to collect a blood sample, send it anonymously to a laboratory facility, and receive pre- and post-test counseling and referral over the phone. A demand for CCT as been documented among untested persons at-risk of HIV infection. This demand has been highest among young, low income, nonwhite males engaging in HIV risk behavior.

The cost of home test kits ($50) may preclude individuals at greatest risk of HIV infection, such as injection drug users, from using this technology. With this potential cost barrier the important public health goal of increased access to HIV testing through home testing may not be realized among persons most at-risk of HIV infection. Many high-risk drug users referred to traditional counseling and testing (CT) do not get tested, or if tested, do not receive their results. Consequently, considering the use of CCT within the context of existing HIV risk-reduction and outreach programs might facilitate access to HIV testing, early diagnosis, and treatment for drug using individuals at-risk of HIV infection.

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Project LinCS: Linking Communities and Scientists

Funding from the CDC for Project LinCS (Linking Communities and Scientists) was awarded in 1996. This multi-site, qualitative study examined community perceptions and concerns regarding government sponsored biomedical research, particularly HIV vaccine research (Strauss, Sengupta et al, 2001). Our site took the lead in writing and producing a video, entitled "We All Have Our Reasons." This video was created using qualitative methodology and involved filming interviews with potential trial participants from three communities-African Americans in Durham, North Carolina; gay men in San Francisco; and injection drug users in Philadelphia.

We were able to successfully capture the distinct and common concerns that potential participants face when considering involvement in large-scale government sponsored research. The video has received wide acclaim and won a Bronze Apple from the National Educational Media Network in the category of Health and Ethics. This video has been distributed nationally by the CDC Clearinghouse and has been featured at many national and local meetings regarding ethical trial conduct and informed consent.

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RARE: Community-Based Rapid Assessment, Rapid Response and Evaluation

Managed in partnership with the Office of Minority Health, the Rapid Assessment, Response, and Evaluation (RARE) Project is a Federal technical assistance effort that helps local communities conduct assessments regarding HIV/AIDS needs and develop community-based interventions and services to address those needs. RARE targets communities in which the impact of HIV on people of color is significant and severe, offering evidence-based strategies to change HIV risk behaviors, knowledge and community structures. The first RARE Projects were 8-10 week pilots that started in June 1999 in three cities: Detroit, Miami, and Philadelphia.

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A-CASI: Applications of Computer Technology in the Assessment of Risk Behaviors

Randomized Controlled Trial of Audio Computer-assisted Self-Interviewing: Utility and Acceptability in Longitudinal Studies.

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NEP: Effectiveness of Multi-Site Needle Exchange Program in Preventing HIV & HBV

NEP and a "Bridge to Treatment": In March of 2001 we completed the data collection Phase of a three-year study of needle exchange programs (NEPs) as a "bridge to treatment". Using our mobile assessment unit, we recruited three groups of injectors via community-based outreach. These groups include 112 regular needle exchange users, 115 IDUs who do not use the exchange, and 115 IDUs who live in a neighborhood without a needle exchange program. We will examine the influence of harm reduction (needle exchange use) on drug treatment participation and the prevalence and incidence of HIV and hepatitis B. Those without antibody have been referred for HbV vaccination. Our hypothesis is that needle exchange use will be associated with earlier and more stable drug treatment patterns.

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WomenFIT: Women Fighting Infection Together

In 1999, the WFIT (Women Fighting Infection Together) study, a women's behavioral HIV prevention protocol, was approved for a feasibility study by the HIVNET. This multi-site randomized controlled trial was designed and led by Dr. Gollub of the AIDS Research Division. The WFIT tested a 4-session, small-group intervention which employed "near peers" as group leaders. The study was conducted at 3 domestic HIVNET sites (Philadelphia, Providence, New York) and enrolled 180 women. The control group for this study received individual risk reduction counseling and HIV testing. The WFIT intervention takes a step-by-step approach, with intensive training activities for the group leaders and multiple quality assurance/monitoring activities to ensure fidelity of the intervention. The study also piloted community activities, including enhanced referrals to reproductive health care services, measurement of women's use of community social service, drug treatment and healthcare agencies, and a full day community training, promoting dialogue between the research institution and local community groups.
WFIT intervention group sessions and assessments were completed by mid-November 2000. Demographic data for these 180 women reveal that 67% are African-American and the mean age is 39 years. 48% have not achieved a high school degree and 75% are unemployed. At baseline, the mean percentage of protected sexual acts (reported via Audio-CASI) with primary partners was 15%, and 20% with all partners. Only 9% reported using the female condom in the past 3 months.

Mean attendance for the 5 total sessions (4 intervention sessions plus the "reunion session") is 83%. Using a 3-point scale (low-medium-high), intervention monitors at all three sites rated the experimental group's level of participation during the 2 1/2 hour group sessions as "high". Intervention acceptability data, taken from the participant exit interview, indicate that participants were very pleased with the intervention. At the 4-wk post intervention assessment, 87% of women reported that they had taken home a female condom; 85% reported that they had used the female condom at least once (57% more than once) over the four-week period. Similarly, 82% reported that they had taken home male condoms; 70% reported that they had used this method at least once.

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LT/LI: Persistent Effects of Low-Intensity/Low-Threshold Drug Risk Counseling

This three year, NIDA funded project, known as the LT/LI project, began in January of 2000 and is testing the hypothesis that involvement in regularly scheduled HIV counseling and testing is a cost effective HIV prevention intervention. In this study, the original participants of the Risk Assessment Project are being recalled and invited to participate in a series of semi-annual HIV counseling and testing sessions. Since these original cohort members have not been seen for more than three years, we expect to observe a rise in seroincidence and risk behaviors.

The project presents special challenges given the length of time since our last contact. Our current contact rate is about 85%. Unfortunately, we are finding a very high rate of mortality, with 28% of our original cohort confirmed deceased. This study will also provide valuable data regarding the long-term drug, health and social impacts of injection drug use since participant data will extend for 14 years by the study's end.

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Interaction of Human Immune Cells, Alcohol and HIV

Acute and chronic alcohol abuse in both humans and experimental animals alters many specific immune functions, and thus has been implicated as a cofactor in HIV/AIDS disease. The mechanisms by which alcohol affects the functions of the human immune cells that are the targets for HIV are largely unknown. There are conflicting data regarding the role of alcohol in HIV infection of immune cells. In the proposed research, we will use immune cells derived from both healthy donors and from chronic alcohol abuses with or without HIV infection to address the following questions using an in vitro model system: 1). Does chronic alcohol use increases immune cell susceptibility to HIV infection at the time of exposure to alcohol? 2). Can chronic alcohol use by HIV-infected individuals increase HIV replication and promote HIV disease progression?

We hypothesize that alcohol affects HIV infection of specific human immune cells including microglia, macrophages and T Lymphocytes through modulation of the functions of the immune cells. These cells are the primary targets for HIV in both central nervous system and peripheral blood and tissues. We will determine whether alcohol enhances susceptibility of the immune cells to HIV infection (entry, attachment, and replication cycle) in vitro and whether alcohol activates and promotes HIV replication in latently infected cells in vitro and ex vivo.

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HPTN 037: Social Network Study

A Phase III Randomized Study to Evaluate the Efficacy of a Network-oriented Peer Educator Intervention for the Prevention of HIV Transmission Among Injection Drug Users And Their Network Members

The intervention tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Providing peer educator training to IDUs may efficiently cultivate sustainable protective behavioral norms related to injection and sexual risk among the IDU educators’ social networks. Prior studies have demonstrated that peer educator programs can realize such normative changes, and it is hypothesized in this study that these normative changes will be reflected in significant reductions in the rates of HIV transmission among the peer educators and the members of their social networks.

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Substance P: Drug Abuse, Substance P and HIV

In collaboration with investigators (Drs. Wen-Zhe Ho and Steven Douglas) from the Department of Immunology at the Children's Hospital of Philadelphia, we are participating in a four year, NIDA funded study of the effects of opioids (e.g., morphine) on the neuropeptide substance P (SP). This relationship is of particular interest since both are involved in modulation of the function of immune cells (microglia, monocytes/macrophages and lymphocytes) and human immunodeficiency virus (HIV) infection.

The overall goal of this research is to understand the mechanism of interaction of opioids and SP in the immunopathogenesis of HIV infection and AIDS. Our general hypothesis is that opioids affect HIV infection of human immune cells by affecting neuropeptides, such as SP, and that opioids and SP have a synergistic effect on HIV replication of human immune cells.Further, we hypothesize that regulation of SP receptor by opioids facilitates HIV entry into human immune cells. Using blood specimens obtained from HIV-infected and non-infected drug users, we will study the relationships between SP levels, HIV infection and drug abuse.

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Project Shakedown



HIV Media Campaign

 


HIVNET 020: Phase I Vaginal Microbicide Study




HPTN 049: Phase I Safety and Acceptability Study of the Vaginal Microbicide 6% Cellulose Sulfate Gel Among HIV-Infected Women

The purpose of this study is to access the safety and acceptability of 6% cellulose sulfate (CS) gel for vaginal use versus a control gel among HIV-infected women, and to access the acceptability of CS gel among the HIV-infected male sexual partners of female participants. The study is a multi-site, Phase I, double blind, randomized, controlled frequency escalation study with 14 days of product exposure and follow-up.

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HPTN 050: Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel

The primary objectives of this study are to assess the safety and toxicity of PMPA gel for vaginal use on vulvar and cervicovaginal mucosa and to assess the systemic absorption and toxicity of PMPA gel in assigned doses and frequency in HIV-uninfected women at low risk for HIV infection and in HIV-infected women.

The secondary objectives of this study are: (1) to assess the acceptability of, and adherence to, a short-term regimen of PMPA gel for vaginal use in low-risk, HIV- uninfected women and in HIV infected women and their male sexual partners when relevant; (2) to examine qualitative aspects of acceptability, adherence, and study burden as a pilot for substantive qualitative and quantitative assessments in future studies; (3) to measure the occurrence of vaginal shedding of HIV before and after the use of PMPA vaginal gel; (4) to measure vaginal flora characteristics before, during, and at the end of PMPA vaginal gel use, and to descriptively examine changes in these characteristics over the course of PMPA vaginal gel use.

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HPTN 035

A multi-center clinical trial that aims to determine whether the candidate microbicides, BufferGel® and PRO 2000, can prevent the sexual transmission of HIV in 3,100 sexually active HIV-negative women. The trial, which was launched in early 2005, involves six sites in Africa and U.S. site.

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HVTN 502

A Multi-center, Double-Blind, Randomized, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the Merck Adenovirus Serotype 5 HIV-1 Vaccine gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) in Adults at High Risk of HIV-1 Infection

Primary Safety: To demonstrate that intramuscular injection of the Merck Adenovirus Serotype 5 HIV-1 gag/pol/nef Vaccine (MRKAd5 HIV-1 gag/pol/nef) is generally safe and well tolerated in 18 to 45 year old HIV-1 seronegative adults with baseline Ad5 titers < 200.

Primary Efficacy: To demonstrate that intramuscular injection of the MRKAd5 HIV-1 gag/pol/nef vaccine (a) reduces the proportion of subjects who acquire HIV-1 infection and/or (b) results in a decrease in the HIV-1 viral load set-point (HIV-1 RNA at ~ 3 months post-diagnosis), in subjects who become HIV-1 infected, relative to placebo recipients.

(See HVTN 504)

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