Cranston R.D.,University of Pittsburgh |
Hoesley C.,University of Alabama at Birmingham |
Carballo-Dieguez A.,Center for Clinical and Behavioral Studies |
Hendrix C.W.,Johns Hopkins University |
And 5 more authors.
AIDS Research and Human Retroviruses | Year: 2014
Dapivirine (DPV) is a nonnucleoside reverse transcriptase inhibitor with a favorable safety profile following vaginal application. A penile tolerance study was conducted prior to further development of DPV as a candidate vaginal microbicide. Twenty-four circumcised and 24 uncircumcised (N=48) healthy HIV-negative male participants aged 18 years or older were randomized 2:1:1 to apply DPV 0.05% gel, matched placebo gel, or universal placebo gel, respectively, to their penis once daily for 7 sequential days. The safety, acceptability, and pharmacokinetic profile of DPV 0.05% gel were assessed by the presence of Grade 2 or higher genitourinary adverse events (AEs) and systemic AEs, a behavioral questionnaire, and pharmacokinetic plasma blood draw, respectively, at the final clinic visit (FCV). There were no Grade 2 genitourinary AEs in 47 participants completing the FCV. One participant in the DPV arm failed to attend the FCV. There were 13 AEs reported; all were Grade 1 except one Grade 2 corneal laceration unrelated to study product. Participants liked the gel to a moderate extent, yet 72% reported they would be "very likely" to use a gel like the one they used in the study every time they have intercourse. DPV was detectable in plasma in all 23 DPV arm study participants at the FCV. On average, the circumcised participants' DPV concentrations were 54% of those in uncircumcised participants (p=0.07). Topical seven-day penile application of DPV 0.05% gel was locally and systemically safe, was acceptable to male participants, and resulted in systemic exposure to the drug. © Mary Ann Liebert, Inc.
Nguyen H.T.,National Institute of Hygiene and Epidemiology |
Tran A.V.,Hanoi Medical University |
Nguyen N.B.,National Institute of Hygiene and Epidemiology |
Nguyen S.H.,Hanoi Medical University |
And 4 more authors.
American Journal of Public Health | Year: 2015
Objectives: We implemented an intervention to reduce drug use in an urban commune in northern Vietnam. Methods: We encouraged the intervention commune to accept responsibility for developing their own intervention strategies based on a community mobilization model used in southern, rural China. We selected a comparison commune, which had demographic characteristics and a drug history similar to the intervention commune. The 2-year incidence of new drug users was estimated retrospectively in the intervention and comparison communes between baseline (2003) and follow-up (2009). Results: Increased incidence of new (noninjecting) drug users between 2003 and 2009 in the intervention commune was lower than that in the comparison commune, and these participants expressed more positive attitudes toward local authority and people with drug use and HIV/AIDS. Increased condom use during last intercourse with female sex workers and with female casual partners was observed in the intervention commune. HIV prevalence and positive opioid tests decreased more in the intervention commune. Conclusions: Our results suggested that the community mobilization had a positive influence in the intervention commune.
Kintu K.,Makerere University |
Andrew P.,Family Health International 360 |
Musoke P.,Makerere University |
Richardson P.,Johns Hopkins University |
And 11 more authors.
Journal of Acquired Immune Deficiency Syndromes | Year: 2013
BACKGROUND: The development of a safe and effective vaccine against HIV type 1 for the prevention of mother-to-child transmission of HIV would significantly advance the goal of eliminating HIV infection in children. Safety and feasibility results from phase 1, randomized, double-blind, placebo-controlled trial of ALVAC-HIV vCP1521 in infants born to HIV type 1-infected women in Uganda are reported. METHODS: HIV-exposed infants were enrolled at birth and randomized (4:1) to receive vaccine or saline placebo intramuscular injections at birth, 4, 8, and 12 weeks of age. Vaccine reactogenicity was assessed at vaccination and days 1 and 2 postvaccination. Infants were followed until 24 months of age. HIV infection status was determined by HIV DNA polymerase chain reaction. RESULTS: From October 2006 to May 2007, 60 infants (48 vaccine and 12 placebo) were enrolled with 98% retention at 24 months. One infant was withdrawn, but there were no missed visits or vaccinations among the 59 infants retained. Immune responses elicited by diphtheria, polio, hepatitis B, haemophilus influenzae type B, and measles vaccination were similar in the 2 arms. The vaccine was well tolerated with no severe or life-threatening reactogenicity events. Adverse events were equally distributed across both study arms. Four infants were diagnosed as HIV infected [3 at birth (2 vaccine and 1 placebo) and 1 in vaccine arm at 2 weeks of age]. CONCLUSION: The ALVAC-HIV vCP1521 vaccination was feasible and safe in infants born to HIV-infected women in Uganda. The conduct of high-quality infant HIV vaccine trials is achievable in Africa. Copyright © 2013 by Lippincott Williams & Wilkins.
Vuylsteke B.,Institute of Tropical Medicine |
Semde G.,Family Health International 360 |
Auld A.F.,Centers for Disease Control and Prevention |
Sabatier J.,Centers for Disease Control and Prevention |
And 3 more authors.
Journal of Acquired Immune Deficiency Syndromes | Year: 2015
Background: Antiretroviral therapy (ART) for HIV-infected sex workers is an important HIV prevention strategy. However, sex workers may have additional challenges for retention in ART care. The objectives of this study were to assess retention of sex workers on ART in a routine setting in Ivory Coast and identify risk factors for loss to follow-up (LTFU). Methods: The design was a retrospective cohort study. An analysis of clinic files was conducted in 2 sites providing ART services to sex workers in Ivory Coast. Demographic, behavior, and clinical data of female and male sex workers on ART were abstracted onto a standardized anonymous data collection form. Data collection took place between May 11 and 28, 2010. Results: A total of 376 female and 38 male sex workers were included in the analysis. The retention probability was 75% at 6 months, 68% at 12 months, 55% at 24 months, and 47% at 36 months. Attrition was mainly because of LTFU. Factors significantly associated with LTFU in bivariate analysis were lower schooling level, later calendar year of starting ART, and not receiving initial adherence counseling. Later year of starting ART and not receiving adherence counseling at ART initiation remained significantly associated with LTFU in a multivariate Cox regression model. Conclusions: To improve the retention of sex workers on ART, there is a need for more in-depth investigation of the role of pre-ART counseling and the increasing rates of LTFU with each calendar year. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
O'Neill E.,University of North Carolina at Chapel Hill |
Tang J.,University of North Carolina at Chapel Hill |
Garrett J.,University of North Carolina at Chapel Hill |
Hubacher D.,Family Health International 360
Contraception | Year: 2014
Objective Subdermal contraceptive implant continuation has not been well studied in Africa. We conducted a secondary data analysis to compare baseline characteristics of Kenyan women who continued to use the subdermal implant at 12 months to those who did not. Study Design Kenyan women aged 18-24 years who presented to a family planning clinic for short-acting hormonal contraception were offered a two-rod subdermal implant instead. Participants were followed for 12 months after initiation of their contraceptive method. Statistical analysis included Pearson's chi-square or Fisher's exact tests for comparisons of proportions. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated to determine factors associated with continuation. Results Eighty-six (89%) of the 97 women who chose the implant were followed for 12 months. Of these women, 68 (79%) continued to use the implant. None of the factors we examined had a statistically significant association with continued use of the implant. Duration of intended use was the only strong factor; 83% of women with 3 + years of need continued using the implant, compared to 56% of those with shorter needs (Risk ratio = 1.48, 95% CI = 0.94-2.31). No substantive continuation differences were found when comparing other participant characteristics including months with their current partner, personal desire and partner preference for future children, previous use of modern birth control and other factors. Conclusion High implant continuation rates were noted regardless of previous use of modern birth control, partner preference for children or baseline concern for menstrual change. Implications Contraceptive use in Africa continues to focus on short-acting contraceptives despite the proven superior efficacy of long-acting reversible contraceptives in other settings. The high subdermal implant continuation among Kenyan women in this prospective study, regardless of baseline characteristics, supports the need for increasing access and future research in this population. © 2014 Elsevier Inc. All rights reserved.