Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial.

CAPRISA, 2014.Abstract available in pdf

Randomized controlled phase IIa clinical trial of safety, pharmacokinetics and pharmacodynamics of tenofovir and tenofovir plus levonorgestrel releasing intravaginal rings used by women in Kenya

IntroductionGlobally, many young women face the overlapping burden of HIV infection and unintended pregnancy. Protection against both may benefit from safe and effective multipurpose prevention technologies.MethodsHealthy women ages 18–34 years, not pregnant, seronegative for HIV and hepatitis B surface antigen, not using hormonal contraception, and at low risk for HIV were randomized 2:2:1 to continuous use of a tenofovir/levonorgestrel (TFV/LNG), TFV, or placebo intravaginal ring (IVR). In addition to assessing genital and systemic safety, we determined TFV concentrations in plasma and cervicovaginal fluid (CVF) and LNG levels in serum using tandem liquid chromatography-mass spectrometry. We further evaluated TFV pharmacodynamics (PD) through ex vivo CVF activity against both human immunodeficiency virus (HIV)-1 and herpes simplex virus (HSV)-2, and LNG PD using cervical mucus quality markers and serum progesterone for ovulation inhibition.ResultsAmong 312 women screened, 27 were randomized to use one of the following IVRs: TFV/LNG (n = 11); TFV-only (n = 11); or placebo (n = 5). Most screening failures were due to vaginal infections. The median days of IVR use was 68 [interquartile range (IQR), 36–90]. Adverse events (AEs) were distributed similarly among the three arms. There were two non-product related AEs graded >2. No visible genital lesions were observed. Steady state geometric mean amount (ssGMA) of vaginal TFV was comparable in the TFV/LNG and TFV IVR groups, 43,988 ng/swab (95% CI, 31,232, 61,954) and 30337 ng/swab (95% CI, 18,152, 50,702), respectively. Plasma TFV steady state geometric mean concentration (ssGMC) was <10 ng/ml for both TFV IVRs. In vitro, CVF anti-HIV-1 activity showed increased HIV inhibition over baseline following TFV-eluting IVR use, from a median of 7.1% to 84.4% in TFV/LNG, 15.0% to 89.5% in TFV-only, and −27.1% to −20.1% in placebo participants. Similarly, anti-HSV-2 activity in CVF increased >50 fold after use of TFV-containing IVRs. LNG serum ssGMC was 241 pg/ml (95% CI 185, 314) with rapid rise after TFV/LNG IVR insertion and decline 24-hours post-removal (586 pg/ml [95% CI 473, 726] and 87 pg/ml [95% CI 64, 119], respectively).ConclusionTFV/LNG and TFV-only IVRs were safe and well tolerated among Kenyan women. Pharmacokinetics and markers of protection against HIV-1, HSV-2, and unintended pregnancy suggest the potential for clinical efficacy of the multipurpose TFV/LNG IVR.Clinical Trial RegistrationNCT03762382 [https://clinicaltrials.gov/ct2/show/NCT03762382

Experience of Forced Sex and Subsequent Sexual, Drug, and Mental Health Outcomes: African American and Hispanic Women in the Southeastern United States

OBJECTIVES: This cross-sectional study examined African American and Hispanic women’s (N = 1,509) self-reports of unwanted forced sex and its association with behavioral and mental health outcomes after the event. METHODS: Twenty percent of the women had experienced forced sex (1st occurrence at age 15 years or younger for 10%, 1st occurrence at older than 15 years of age for 10%). RESULTS: Regardless of when forced sex 1st occurred, women were more likely to have engaged in unprotected vaginal and anal sex, to have had multiple unprotected sex partners, to have sexually transmitted infections, to have reported binge drinking and illicit drug use, and to exhibit distress and have received mental health counseling. CONCLUSIONS: Forced sex may have wide-ranging behavioral and mental health consequences years later

“Research participants want to feel they are better off than they were before research was introduced to them”: engaging cameroonian rural plantation populations in HIV research

<p>Abstract</p> <p>Background</p> <p>During a period of evolving international consensus on how to engage communities in research, facilitators and barriers to participation in HIV prevention research were explored in a rural plantation community in the coastal region of Cameroon.</p> <p>Methods</p> <p>A formative rapid assessment using structured observations, focus group discussions (FGD), and key informant interviews (KIIs) was conducted with a purposive non-probabilistic sample of plantation workers and their household members. Eligibility criteria included living or working >1 year within the plantation community and age >18 years. Both rapid and in-depth techniques were used to complete thematic analysis.</p> <p>Results</p> <p>Sixty-five persons participated in the study (6 FGDs and 12 KIIs). Participants viewed malaria and gastrointestinal conditions as more common health concerns than HIV. They identified three factors as contributing to HIV risk: concurrent sexual relationships, sex work, and infrequent condom use. Interviewees perceived that the community would participate in HIV research if it is designed to: (1) improve community welfare, (2) provide comprehensive health services and treatment for illnesses, (3) protect the personal information of participants, especially those who test positive for HIV, (4) provide participant incentives, (5) incorporate community input, and (6) minimize disruptions to “everyday life”. Barriers to participation included: (1) fear of HIV testing, (2) mistrust of researchers given possible disrespect or intolerance of plantation community life and lack of concern for communication, (3) time commitment demands, (3) medical care and treatment that would be difficult or costly to access, and (4) life disruptions along with potential requirements for changes in behaviour (i.e., engage in or abstain from alcohol use and sex activities).</p> <p>Conclusions</p> <p>Consistent with UNAIDS guidelines for good participatory practice in HIV prevention research, study participants placed a high premium on researchers’ politeness, trust, respect, communication, tolerance and empathy towards their community. Plantation community members viewed provision of comprehensive health services as an important community benefit likely to enhance HIV research participation.</p

Social and psychological correlates of unprotected anal intercourse among Hispanic-American women: implications for STI/HIV prevention

Heterosexual anal intercourse is associated with increased risk for HIV and other sexually transmitted infections. Research on the social and psychological risk factors associated with heterosexual unprotected anal intercourse among Hispanic women in the USA is limited. We examined demographic, mental health, relationship power, sexual self-efficacy, self-esteem, acculturation and HIV knowledge as correlates of unprotected anal intercourse among 514 HIV-negative Hispanic women, 18 to 59 years of age, residing in one urban county in southern Florida. In both unadjusted and adjusted results, the likelihood of engaging in unprotected anal intercourse was associated with food insecurity in the past 30 days (adjusted odds ratio [AOR] = 1.57, 95% confidence interval [CI] 1.03, 2.40) and more interpersonal power attributed to the male partner (AOR = 1.63, 95%CI 1.08, 2.45). Not significant, yet of possible importance, were ever having engaged in exchange sex (AOR = 1.96, 95%CI = 0.97, 3.98) and lower HIV knowledge (AOR = 0.80, 95%CI = 0.63, 1.01). Interventions aimed at reducing heterosexual unprotected anal intercourse risk for HIV infection among Hispanic women may benefit by addressing socioeconomic and interpersonal issues, and assessing HIV knowledge and comprehension