To view Dr. Coates’ presentation, please click here.
To view other presentations on the “Current Imperatives in HIV Prevention and Treatment” panel, please click here.]]>
CROI 2015, February 23-26, 2015, Seattle, Washington
FACTS 001, a double-blind placebo-controlled phase 3 trial, found that tenofovir 1% vaginal gel did not protect South African women who used it before and after sex from acquiring HIV infection . As in the VOICE trial , poor adherence appeared to contribute to tenofovir gel’s failure in the 2000-woman FACTS study. So far only a 900-woman phase 2b study, CAPRISA 004 , found that tenofovir gel protects women from HIV. FACTS findings proved particularly disappointing because the trial went to some length to encourage good adherence to gel use.
FACTS 001 enrolled 18- to 30-year-old HIV-negative sexually active women willing to use effective contraception and condoms. Researchers randomized over 2000 women to tenofovir 1% gel or to placebo and instructed women to apply the gel 12 hours before and within 12 hours after sex, the same schedule used in CAPRISA 004. All women received intensive ongoing counseling on gel adherence and HIV risk reduction. Study participants made monthly visits for HIV testing, safety checks, and new gel. A case-cohort substudy of 214 women assessed tenofovir levels in cervicovaginal fluid collected monthly.
The FACTS efficacy analysis involved 1015 women randomized to tenofovir and 1014 randomized to placebo More than 90% of women attended study visits. Median age of the study group stood at 23, collectively younger than women in VOICE or CAPRISA 004. Almost 90% of women were single, and almost two thirds were living with parents or siblings, so they probably were not having sex at home, where applying gel before and after sex would be more convenient.
In both study arms 56% of women had secondary or higher education. Only one third of women reported consistent condom use, and only 1% reported anal sex. Few study participants–18% in the tenofovir arm and 17% in the placebo arm–said they perceived greater than usual HIV risk in the past 28 days. Women had a median of 1 sex partner in the past 28 days.
After more than 1500 person-years of follow-up, the investigators counted 61 HIV infections in the tenofovir group and 62 in the placebo group. HIV incidence was precisely the same in both study arms–4.0 per 100 person-years (95% confidence interval [CI] 3.1 to 5.2). As a result the incidence rate ratio comparing the tenofovir group with the placebo group sat squarely at 1.0 (95% CI 0.7 to 1.4).
In the case-cohort analysis of 1075 samples from 214 women, tenofovir could be detected in 64% of cervicovaginal samples. Two thirds of women had detectable tenofovir at some quarterly visit, 22% had detectable drug at all quarterly visits, and 13% never had detectable tenofovir.
In an analysis adjusted for age, HSV-2 status, living with parents, and baseline factors related to HIV incidence, women who had detectable tenofovir in cervicovaginal samples and reporting sex in the past 10 days had lower HIV incidence that women using placebo (adjusted hazard ratio 0.48, 95% CI 0.23 to 0.97). That result indicated 52% protection with tenofovir (P = 0.04).
Considering all adherence data, the FACTS 001 team calculated that women used gel for an average of 50% to 60% of sex acts. The investigators concluded that “the majority of participants were not able to achieve sufficiently high levels of gel coverage required for protection.” They stressed the “urgent need for a range of HIV prevention options for young women which may be easier to integrate into their lives.”
1. Rees H, Delany-Moretlwe SA, Lombard C, et al. FACTS 001 phase III trial of pericoital tenofovir 1% gel for HIV prevention in women. CROI 2015. February 23-26, 2015. Seattle, Washington. Abstract 26LB.
2. Marrazzo JM, Ramjee G, Richardson BA, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015;372:509-518. http://www.nejm.org/doi/full/10.1056/NEJMoa1402269
3. Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329:1168-1174. http://www.sciencemag.org/content/329/5996/1168.long
Click here for the webcast.]]>
To learn more about Dr. Landovitz, please visit http://chipts.ucla.edu/people/raphael-landovitz/
For other presentations from CROI 2015, please visit http://www.croiconference.org/]]>
Paying patients in the Bronx and in Washington — where infection rates are high among poor blacks and Hispanics — up to $280 a year to take their pills daily improved overall adherence rates very little, the study’s authors said.
The hope was that the drugs would not only improve the health of the people taking them, but help slow the spread of H.I.V. infections. H.I.V. patients who take their medicine regularly are about 95 percent less likely to infect others than patients who do not. The Centers for Disease Control and Prevention estimates that only a quarter of all 1.1 million Americans with H.I.V. are taking their drugs regularly enough to not be infectious.
Click here for the full article.]]>
On Thursday, February 12, 2015, Dr. Andrew Jolivette presented to the Los Angeles County Commission on HIV as part of the CHIPTS HIV Research and Community Colloquia Series. He presented findings from his “Indian Blood” study, which was a two year ethnographic, community-based study of risk factors for HIV/AIDS seroconversion among mixed-race American Indians in the San Francisco Bay Area. The presentation explores six key factors that produce greater levels of risk within the Native population through the development of the Indian Blood Psycho-Social Nexus (IBPN) of Risk Model.
Andrew Jolivette (Opelousa/Atakapa-Ishak) Ph.D., is an accomplished educator, writer, speaker, and social/cultural critic. His work spans many different social and political arenas – from education reform and cultural representation in Native America to community of color identity issues, critical mixed-race movement building, LGBT/Queer community of color identity issues and gay marriage, and AIDS disparities within Indigenous and people of color communities.
Dr. Jolivette is Associate Professor and Department Chair in American Indian Studies at San Francisco State University, where he is an affiliated faculty member in Educational Leadership and Race and Resistance Studies. Dr. Jolivette is an IHART (Indigenous HIV/AIDS Research Training) Fellow at the Indigenous Wellness Research Institute at the University of Washington in Seattle. In 2005, he completed a Ford Foundation Postdoctoral Fellowship through the National Academy of Sciences.
The move to cut $4 million from the contracts, paid for with federal money, marked the latest clash between the county and the nonprofit AIDS Healthcare Foundation, one of the largest providers of medical services to HIV patients in the region.
The foundation and the county have tangled politically and in court over other contracts and issues, including enforcement of requirements for adult film actors to use condoms and a foundation drive to create a breakaway public health department serving the city of Los Angeles.
Read the full article here.]]>
A recently-discovered form of HIV in Cuba has been found to progress into AIDS some three times faster than the most common strains of the virus, according to a recent study.
The study, conducted by researchers from the University of Leuven in Belgium, followed several reports of HIV-infected people in Cuba developing AIDS in less than three years, far faster than the usual 10 years it typically takes. All patients infected with CRF19, a recently-discovered strain of the HIV virus, had higher levels of it in their body.
Read the full article here.]]>
He had tested positive for gonorrhea and chlamydia. That meant she was very likely infected.
Loud, insult-fueled cross-accusations ensued. But the conversation did not disintegrate, as might otherwise be expected.
That is because William, who asked to be identified by his middle name to protect his privacy, was able to include some good news. The sort-of girlfriend — his term — would not need to face the hassle and embarrassment of being tested.
His clinic had issued prescriptions for them both; William himself could give her the antibiotics. For free. Immediately.
Read the full article here.]]>
Dr. Rotheram’s Slides
January 26, 2015 – Dr. Rotheram provided the Keynote Address for CHIPTS’ Cross-Core meeting, focusing on her work with community health workers in South Africa.]]>
Click to download Dr. Banerjee's slides (13)
CHIPTS Methods Seminar – UCLA-Semel Institute Center for Community Health
Sudipto Banerjee, PhD
Professor and Chair
Dept. of Biostatistics
UCLA Fielding School of Public Health
Tuesday, February 3, 2-3pm
Center for Community Health, UCLA Wilshire Center
10920 Wilshire Blvd., Suite 350, Conference Room
Advances in Geographical Information Systems (GIS) and related software have led to a burgeoning of spatial-temporal databases. Statisticians and spatial analysts today routinely encounter situations where they seek to model relationships among variables across space and time. In recent times interest has turned to inferring about rates of change of health outcomes over space and time. Why are such questions relevant and how should we estimate them? One example considers analyzing monthly hospitalization rates aggregated over the counties in California where hospital management seeks to carry out inference on gradients of the temporal process, while at the same time accounting for spatial similarities across neighboring regions. Another example (an extension) is to analyze spatial-temporal gradients for environmental pollutants to understand the nature of dispersal of pollutants. Here, we are interested in directional rates of change over space at any given time, temporal gradients at any given location and even “mixed” gradients, e.g., how the temporal rate of change varies over space. We will work within a fully Bayesian inferential paradigm without unnecessary, and potentially inflexible, parametric modeling assumptions and obtain the full posterior predictive distribution for these gradients using process-based models.
(Co-authors: Harrison Quick and Bradley P. Carlin)]]>