Cost and threshold analysis of an HIV/STI/hepatitis prevention intervention for young men leaving prison: Project START.

The objectives of this study were to: (a) estimate the costs of providing a single-session HIV prevention intervention and a multi-session intervention, and (b) estimate the number of HIV transmissions that would need to be prevented for the intervention to be cost-saving or cost-effective (threshold analysis). Project START was evaluated with 522 young men aged 18-29 years released from eight prisons located in California, Mississippi, Rhode Island, and Wisconsin. Cost data were collected prospectively. Costs per participant were $689 for the single-session comparison intervention, and ranged from $1,823 to 1,836 for the Project START multi-session intervention. From the incremental threshold analysis, the multi-session intervention would be cost-effective if it prevented one HIV transmission for every 753 participants compared to the single-session intervention. Costs are comparable with other HIV prevention programs. Program managers can use these data to gauge costs of initiating these HIV prevention programs in correctional facilities.

HIV, STD, and hepatitis risk behaviors of young men before and after incarceration.

High rates of HIV, STD and hepatitis and associated risk behaviors have been documented among persons entering correctional facilities. However, there is a paucity of data on risk behaviors after release from custody. This study documents risk behaviors and informs intervention development targeting young men leaving incarcerated settings. We enrolled and interviewed 106 men from five prisons up to 60 days prior to their release from prison and interviewed them again four times after their release (at 1-week, 1-, 3- and 6-months). At enrollment, men were 18-29 years of age. Nearly 54% identified as African American, while 27% identified as White, 10% identified as Hispanic/Latino and 10% identified as "other". Approximately 83% had been incarcerated multiple times, 37% reported a prior STD diagnosis and their mean lifetime number of sex partners was 36 (median = 20). Many reported multiple sex partners and inconsistent condom use after release. A significant decrease in condom use during vaginal sex with primary committed female partners and in oral sex with both committed and casual female partners after release from prison were reported from 1-6 months. These young men are at sexual risk of HIV, STD and hepatitis infection after release from prison. Interventions are needed to prevent this population from acquiring and transmitting HIV, STD and hepatitis.

Women's anal sex practices: implications for formulation and promotion of a rectal microbicide.

To gain insight into practices that may inform formulation and use of rectal microbicides, in-depth interviews were conducted with an ethnically diverse sample of 28 women who engage in anal intercourse. Microbicides are compounds under development to decrease sexually transmitted infections. Most women practiced anal sex in conjunction with vaginal intercourse. Anal sex typically was not preplanned, and few women reported preparation. Condom use was rare. Most women relied on saliva, vaginal fluids, prelubricated condoms, or used no lubrication at last intercourse. Women were uncertain about the amount of lubricant used during sex, with typical estimates of 1 to 2 teaspoons. This may prove challenging to the formulation and promotion of rectal microbicides, as substantially higher amounts may be required. Additional challenges include infrequent use of packaged lubricants, and typical male lubricant application, which may make women's control of rectal microbicides more difficult. Women overwhelmingly expressed interest in rectal microbicides.

Neurocognitive and psychological contributions to quality of life in HIV-1-infected women.

OBJECTIVES: The purpose of this study was to examine the impact of neurocognitive and emotional distress and immune system dysfunction on quality of life in women with HIV. METHODS: Thirty-six HIV-seropositive women were administered measures of mood status (Profile of Mood States), quality of life (Multidimensional Quality of Life Questionnaire for Persons with HIV) and cognitive function. CD4 cell counts were obtained as an indicator of immune system status. RESULTS: Regression analyses revealed that independent of severity of emotional distress, neurocognitive deficits on measures of executive control and speed of information processing were associated with reduced quality of life. Emotional status also was associated with quality of life and together with neurocognitive performance accounted for most of the variance associated with quality of life. Reduced CD4 cell count was significantly associated with neurocognitive deficits, but not severity of emotional distress or quality of life. CONCLUSIONS: Quality of life among women who are infected with HIV is strongly influenced by both neurocognitive and emotional status, as women with the greatest neurocognitive impairment and emotional distress report the poorest quality of life.

Acceptability of a novel vaginal microbicide during a safety trial among low-risk women.

CONTEXT: The increasing recognition that women who are unable or unwilling to discuss or use condoms with their sexual partners need female-controlled methods for preventing sexually transmitted diseases (STDs), including HIV, has led to considerable focus on the development of vaginal microbicides. While many such products are being tested for safety and effectiveness, clinical trials generally overlook another key factor in a product's impact on infection rates-its acceptability to users. METHODS: A Phase I clinical trial of a microbicidal gel included an assessment of the product's acceptability among 27 low-risk participants. Information on acceptability was gathered from structured interviews, participants' daily diaries and unstructured exit interviews. RESULTS: Participants reported only minor side effects of product use, such as itching, burning and difficulty urinating; two women developed candida infections while participating in the study. None of the side effects could be conclusively linked to use of the gel. Some women noted product discharge and messiness as drawbacks of the method, but this experience varied according to how often the women applied the gel. For example, one-third of those who used it once daily said that at least some of the time, it was too "wet or drippy," compared with two-thirds of women who inserted the gel twice a day. However, participants considered these "nuisance factors" that could be outweighed by the potential protective characteristics of the product. The majority reported that they would use the product if it were available and proven efficacious, and if they perceived that they were at risk of STD infection. CONCLUSIONS: Additional testing of this product is urgently needed. Furthermore, as other products approach Phase I testing, acceptability assessments should be a key component of clinical trials.